Page 12«..11121314..2030..»

Category Archives: Corona Virus

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design -…

Posted: July 27, 2022 at 11:23 am

NEW YORK and MAINZ, Germany, July 27, 2022 Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 g dose level. This next-generation bivalent COVID-19 vaccine candidate, BNT162b5, consists of RNAs encoding enhanced prefusion spike proteins for the SARS-CoV-2 ancestral strain (wild-type) and an Omicron variant. The enhanced spike protein encoded from the mRNAs in BNT162b5 has been modified with the aim of increasing the magnitude and breadth of the immune response that could better protect against COVID-19.

This is the first of multiple vaccine candidates with an enhanced design which the companies plan to evaluate as part of a long-term scientific COVID-19 vaccine strategy to potentially generate more robust, longer-lasting, and broader immune responses against SARS-CoV-2 infections and associated COVID-19.

BNT162b5 will be evaluated in a U.S.-based study enrolling approximately 200 participants aged between 18 and 55 who have received one booster dose of a U.S.-authorized COVID-19 vaccine at least 90 days prior to their first study visit. Participants will be stratified by the number of months since their last dose of COVID-19 vaccine received prior to entering the study (three to six months or more than six months). The study does not include a placebo (injection with no active ingredient). For more information about this study please visit http://www.clinicaltrials.govon this link.

The Pfizer-BioNTech COVID-19 Vaccine, BNT162b2, which is based on BioNTechs proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

U.S. Indication & Authorized Use

Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.

Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide:

Primary Series

Booster Series

COMIRNATY INDICATIONCOMIRNATY (COVID-19 Vaccine, mRNA) is a vaccine approved for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

COMIRNATY AUTHORIZED USESCOMIRNATY (COVID-19 Vaccine, mRNA) is FDA authorized under Emergency Use Authorization (EUA) to provide:

Primary Series

Booster Dose

Emergency Use AuthorizationEmergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in individuals 6 months of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

INTERCHANGEABILITYFDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use.

The formulations of the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 6 months through 4 years of age, 5 through 11 years of age, and 12 years of age and older are different and should therefore not be used interchangeably. The Pfizer-BioNTech COVID-19 Vaccine authorized for use in children 6 months through 11 years of age should not be used interchangeably with COMIRNATY (COVID-19 Vaccine, mRNA).

IMPORTANT SAFETY INFORMATION

Tell your vaccination provider about all of the vaccine recipients medical conditions, including if the vaccine recipient:

Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA) may not protect all vaccine recipients

Seek medical attention right away if the vaccine recipient has any of the following symptoms:

Seek medical attention right away if the vaccine recipient has any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after receiving a vaccine dose:

These may not be all the possible side effects of the vaccine. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.

Click for Fact Sheets and Prescribing Information for individuals 6 months of age and older:

About Pfizer: Breakthroughs That Change Patients LivesAt Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at http://www.Pfizer.com. In addition, to learn more, please visit us on http://www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at http://www.facebook.com/Pfizer.

Pfizer Disclosure NoticeThe information contained in this release is as of July 27, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about Pfizers efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162 mRNA vaccine program, and the Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including an enhanced mRNA-based vaccine candidate, BNT162b5, including a Phase 2 study to evaluate the safety, tolerability, and immune response of BNT162b5 at a 30-g dose level, the companies long-term scientific COVID-19 strategy, qualitative assessments of available data, potential benefits, expectations for clinical trials, potential regulatory submissions, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including Phase 1/2/3 or Phase 4 data), including any data for BNT162b2, BNT162b5, any monovalent, bivalent or variant-adapted vaccine candidates or any other vaccine candidate in the BNT162 program in any of our studies in pediatrics, adolescents, or adults or real world evidence, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies, in real world data studies or in larger, more diverse populations following commercialization; the ability of BNT162b2, BNT162b5, any monovalent, bivalent or variant-adapted vaccine candidates or any future vaccine to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when submissions to request emergency use or conditional marketing authorizations for BNT162b5, BNT162b2 in additional populations, for a potential booster dose for BNT162b2, any monovalent, bivalent or variant-adapted vaccine candidates or any potential future vaccines (including potential future annual boosters or re-vaccination), and/or other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b5, BNT162b2, any monovalent or bivalent vaccine candidates or any other potential vaccines that may arise from the BNT162 program, including a potential variant-based, higher dose, or bivalent vaccine, and if obtained, whether or when such emergency use authorizations or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b5, BNT162b2 (including any requested amendments to the emergency use or conditional marketing authorizations), any monovalent, bivalent or variant-adapted vaccine candidates, or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccines benefits outweigh its known risks and determination of the vaccines efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist which may lead to reduced revenues or excess inventory; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccines formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant-based or next generation vaccines; the risk that we may not be able to maintain or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; uncertainties regarding the impact of COVID-19 on Pfizers business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizers Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov and http://www.pfizer.com.

About BioNTechBiopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit http://www.BioNTech.com.

BioNTech Forward-looking StatementsThis press release contains forward-looking statements of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTechs efforts to combat COVID-19; the collaboration between BioNTech and Pfizer including the program to develop a COVID-19 vaccine and COMIRNATY (COVID-19 vaccine, mRNA) (BNT162b2) ( including a bivalent mRNA vaccine candidate, BNT162b5, including a Phase 2 study to evaluate the safety, tolerability, and immune response of BNT162b5 at the 30-g dose level, the Companies long-term scientific COVID-19 strategy, qualitative assessments of available data, potential benefits, expectations for clinical trials, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply); our expectations regarding the potential characteristics of BNT162b2, BNT162b5, any monovalent or bivalent vaccine candidates or any future vaccine in our clinical trials and/or in commercial use based on data observations to date; the ability of BNT162b2, BNT162b5, any monovalent or bivalent vaccine candidates or any future vaccine, to prevent COVID-19 caused by emerging virus variants; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including Phase 1/2/3 or Phase 4 data), including the data discussed in this release for BNT162b2, BNT162b5, any monovalent or bivalent vaccine candidates or any other vaccine candidate in BNT162 program in any of our studies in pediatrics, adolescents, or adults or real world evidence, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications and interpretations; the expected time point for additional readouts on efficacy data of BNT162b2 or BNT162b5 in our clinical trials; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; whether and when submissions to request emergency use or any marketing approval for BNT162b5, BNT162b2 in additional populations, for a potential booster dose for BNT162b2, any monovalent, bivalent or variant-adapted vaccine candidates or any potential future vaccines (including potential future annual boosters or re-vaccination), and/or other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b5, BNT162b2, any monovalent or bivalent vaccine candidates or any other potential vaccines that may arise from the BNT162 program, including a potential variant-based, higher dose, or bivalent vaccine, and if obtained, whether or when such emergency use authorizations or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2, BNT162b5, any monovalent, bivalent or variant-adapted vaccine candidates, or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccines benefits outweigh its known risks and determination of the vaccines efficacy and, if approved, whether it will be commercially successful; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; the ability of BioNTech to supply the quantities of BNT162, BNT162b5, any monovalent or bivalent vaccine candidates or any future vaccine, to support clinical development and market demand, including our production estimates for 2022; that demand for any products may be reduced or no longer exist which may lead to reduced revenues or excess inventory; the availability of raw materials to manufacture a vaccine; our vaccines formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the ability to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant-based vaccines; the ability to maintain or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; and uncertainties regarding the impact of COVID-19 on BioNTechs trials, business and general operations. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our productions capabilities; and other potential difficulties.For a discussion of these and other risks and uncertainties, see BioNTechs Annual Report as Form 20-F for the Year Ended December 31, 2021, filed with the SEC on March 30, 2022, which is available on the SECs website at http://www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

CONTACTS

Pfizer:Media Relations+1 (212) 733-7410[emailprotected]

Investor Relations+1 (212) 733-4848[emailprotected]

BioNTech:Media RelationsJasmina Alatovic+49 (0)6131 9084 1513[emailprotected]

Investor RelationsSylke Maas, Ph.D.+49 (0)6131 9084 1074[emailprotected]

View post:

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design -...

Posted in Corona Virus | Comments Off on Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design -…

New studies bolster theory coronavirus emerged from the wild – Daily Independent

Posted: at 11:23 am

By LAURA UNGAR

Two new studies provide more evidence that the coronavirus pandemic originated in a Wuhan, China market where live animals were sold further bolstering the theory that the virus emerged in the wild rather than escaping from a Chinese lab.

The research, published online Tuesday by the journal Science, shows that the Huanan Seafood Wholesale Market was likely the early epicenter of the scourge that has now killed nearly 6.4 million people around the world. Scientists conclude that the virus that causes COVID-19, SARS-CoV-2, likely spilled from animals into people two separate times.

All this evidence tells us the same thing: It points right to this particular market in the middle of Wuhan, said Kristian Andersen a professor in the Department of Immunology and Microbiology at Scripps Research and coauthor of one of the studies. I was quite convinced of the lab leak myself until we dove into this very carefully and looked at it much closer.

In one study, which incorporated data collected by Chinese scientists, University of Arizona evolutionary biologist Michael Worobey and his colleagues used mapping tools to estimate the locations of more than 150 of the earliest reported COVID-19 cases from December 2019. They also mapped cases from January and February 2020 using data from a social media app that had created a channel for people with COVID-19 to get help.

They asked, Of all the locations that the early cases could have lived, where did they live? And it turned out when we were able to look at this, there was this extraordinary pattern where the highest density of cases was both extremely near to and very centered on this market, Worobey said at a press briefing. Crucially, this applies both to all cases in December and also to cases with no known link to the market And this is an indication that the virus started spreading in people who worked at the market but then started to spread into the local community.

Andersen said they found case clusters inside the market, too, and that clustering is very, very specifically in the parts of the market" where they now know people were selling wildlife, such as raccoon dogs, that are susceptible to infection with the coronavirus.

In the other study, scientists analyzed the genomic diversity of the virus inside and outside of China starting with the earliest sample genomes in December 2019 and extending through mid-February 2020. They found that two lineages A and B marked the pandemics beginning in Wuhan. Study coauthor Joel Wertheim, a viral evolution expert at the University of California, San Diego, pointed out that lineage A is more genetically similar to bat coronaviruses, but lineage B appears to have begun spreading earlier in humans, particularly at the market.

Now I realize it sounds like I just said that a once-in-a-generation event happened twice in short succession, Wertheim said. But certain conditions were in place such as people and animals in close proximity and a virus that can spread from animals to people and from person to person. So barriers to spillover have been lowered such that multiple introductions, we believe, should actually be expected, he said.

Many scientists believe the virus jumped from bats to humans, either directly or through another animal. But in June, the World Health Organization recommended a deeper probe into whether a lab accident may be to blame. Critics had said the WHO was too quick to dismiss the lab leak theory.

Have we disproven the lab leak theory? No, we have not, Andersen said. But I think whats really important here is there are possible scenarios and there are plausible scenarios and its really important to understand that possible does not mean equally likely.

The pandemic's origins remain controversial. Some scientists believe a lab leak is more likely and others remain open to both possibilities. But Matthew Aliota, a researcher in the college of veterinary medicine at the University of Minnesota, said in his mind the pair of studies kind of puts to rest, hopefully, the lab leak hypothesis.

Both of these two studies really provide compelling evidence for the natural origin hypothesis," said Aliota, who wasn't involved in either study. Since sampling an animal that was at the market is impossible, "this is maybe as close to a smoking gun as you could get."

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Department of Science Education. The AP is solely responsible for all content.

More here:

New studies bolster theory coronavirus emerged from the wild - Daily Independent

Posted in Corona Virus | Comments Off on New studies bolster theory coronavirus emerged from the wild – Daily Independent

Should you wait for the Omicron booster? In a word, no – Los Angeles Times

Posted: at 11:23 am

If youre like most Americans, youve gotten your primary doses of a COVID-19 vaccine, but you havent gotten the recommended booster shots. So if its been several months since your last primary dose, youre probably due for a booster.

But the companies behind two of the more popular COVID-19 shots, Moderna and the team of Pfizer and BioNTech, have thrown a new variable into the mix. Last month, they said they had new versions of their booster shots that are designed to target the highly infectious Omicron family of COVID variants.

So you may be asking yourself, Should I get a booster shot now, while cases are surging, or should I wait until the new boosters are ready, probably this fall?

The answer, multiple vaccine experts said emphatically and without hesitation, is that theres no time like the present.

Newsletter

Get our free Coronavirus Today newsletter

Sign up for the latest news, best stories and what they mean for you, plus answers to your questions.

Enter email address

Sign Me Up

You may occasionally receive promotional content from the Los Angeles Times.

Definitely get it now! Paula Cannon, a professor of molecular microbiology and immunology at USCs Keck School of Medicine, said in an email.

Trying to predict the future with this virus, even as close as the fall, is not a good idea, she said. And even with the more Omicron-specific vaccines, its still highly unlikely that they will provide absolute protection against infection.

That hardly makes them useless, Cannon noted: They will keep doing the much more important job that all the vaccines do, of protecting against severe illness and death.

The Centers for Disease Control and Prevention urges everyone whos at least 5 years old to get one to two booster shots, depending on their age and the health of their immune system. Thats because the protection offered by the vaccine fades over time.

But Dr. Thomas Campbell, an infectious disease specialist at the University of Colorado School of Medicine, said CDC data show that while two-thirds of the U.S. population has received the full course of primary doses (two shots in the case of Moderna and Pfizers vaccines, or one of the Johnson & Johnson vaccine), just under half of that group has gotten one booster shot. And less than 30% of the adults over 50 whove gotten one booster have gone on to receive the second recommended follow-up, Campbell said.

As a result, only a small percentage of the people across the population have received all the vaccine doses the CDC recommends, he said. Rather than waiting for the next generation of shots, Campbell said, people should get the boosters that theyre eligible for now.

He also noted that the forthcoming Moderna and Pfizer boosters, like the current ones, are available only to people who have received both of their primary doses. So if you stopped after one shot, you need to get the second one. Those shots provide certain forms of protection that the new boosters will not.

Dr. Otto Yang, professor of medicine and associate chief of infectious diseases at the David Geffen School of Medicine at UCLA, said the question of whether to wait for the new boosters has come up quite a lot, and that different people have different opinions. But his advice? Get it now, and then worry about the variant-specific booster later.

One major reason to get the shot now, he said, is the summer surge in reported cases. Another is that the current vaccine remains extremely good at keeping people from getting extremely ill or dying.

But a third reason, he said, is that the upside appears to be relatively small. Data from Moderna shows that its targeted booster was only modestly better than the current one in terms of antibody activity against Omicron.

And besides, antibodies are only part of the story when it comes to battling COVID.

Vaccines stimulate two different parts of the bodys immune system: antibodies, which mainly try to stop a virus from infecting a cell, and T cells, which can kill infected cells and stimulate the production of more antibodies. To oversimplify a bit, Yang said, antibodies seek to prevent an infection from spreading throughout your body, and if that fails, T cells try to prevent the infection from doing much damage.

The antibodies initially generated by the vaccine can prevent the coronavirus from latching on to healthy cells and fueling an infection. But SARS-CoV-2 has evolved, and variants like Omicron have changed enough that those antibodies may not recognize them.

Thats why the vaccines have not been very good at preventing people from getting infected by Omicron, Yang said. But the variant is about 97% the same as the original, he said, so the T cells stimulated by the vaccines arent hindered from doing their job.

Thats why the vaccines have continued to work very well in preventing us from getting [extremely] sick and dying, Yang said. And thats why the new vaccine is not going to be much better than the original, if at all, in preventing severe illness and death.

Research shows that vaccine-induced T cells fade over time, as do the antibodies. Thats why the CDC has recommended booster doses. At this point, the CDC is not recommending a second booster for people under 50 with healthy immune systems, or a third booster for people 50 and older or who are immunocompromised.

Many experts believe that annual or semi-annual COVID-19 boosters may ultimately be needed, but researchers are still studying the longer-term effectiveness of the vaccines.

The thing people have to realize, Campbell said, is that were learning how to use these vaccines as were using them.

One other X factor, according to Cannon, is the evolutionary path SARS-CoV-2 follows.

We dont even know that the virus variants circulating in the fall will still be Omicron and friends, she said. We could be looking at a completely new variant. ... So rather than trying to second-guess anything, we should stick with what we know, which is that boosters work well now, to top up peoples immunity.

The bottom line, Cannon said: If youre eligible for another dose, you should definitely go ahead and get a booster now.

About The Times Utility Journalism Team

This article is from The Times Utility Journalism Team. Our mission is to be essential to the lives of Southern Californians by publishing information that solves problems, answers questions and helps with decision making. We serve audiences in and around Los Angeles including current Times subscribers and diverse communities that havent historically had their needs met by our coverage.

How can we be useful to you and your community? Email utility (at) latimes.com or one of our journalists: Matt Ballinger, Jon Healey, Ada Tseng, Jessica Roy and Karen Garcia.

See the article here:

Should you wait for the Omicron booster? In a word, no - Los Angeles Times

Posted in Corona Virus | Comments Off on Should you wait for the Omicron booster? In a word, no – Los Angeles Times

Where Did the First Quasars Come From? – Sky & Telescope – Sky & Telescope

Posted: July 7, 2022 at 9:11 am

Just 700 million years after the Big Bang, when the universe was still in its infancy, we already see supermassive black holes with the heft of 1 billion Suns. How could they have grown so fast? A team of astronomers is using computer simulations to glimpse what the formation of these dark behemoths might have looked like.

If you wish to make a billion-solar-mass black hole from scratch, to borrow a phrase, you must start with a star or perhaps only with the gas that stars are made of.

While the universes first stars might have made the first black holes, those would have been relatively small on the supermassive scale, with masses of only around 100 Suns. Perhaps the first stars clustered and so when stars made black holes, those black holes merged and then merged again. Even then, such black hole seeds would have been only 1,000, maybe 10,000 solar masses. These black holes would have had to grow super-fast to become supermassive in such a short amount of time.

But theres another way: Some astronomers have put forward the idea that in the small early universe, when gas was dense and pristine, gas clouds could collapse directly into more massive black holes.

The calculations for such massive implosions are delicate, though. Whats to prevent pieces of the gas cloud from cooling and collapsing under their own weight, as star-forming clouds in the modern universe are wont to do?

Some astronomers have suggested the ultraviolet emission of nearby newborn stars might have heated the gas, keeping it too warm to fragment. Others have argued that such specific requirements would make the process too rare to explain the number of supermassive black holes weve already found in the young universe.

Now, Muhammed Latif (United Arab Emirates University), Daniel Whalen (Portsmouth University, UK, and University of Vienna), and colleagues report in Nature that massive black holes can form without these special conditions.

The finding relies on computer simulations, which rebuild the conditions of the infant universe, when it was less than 100 million years old. Simulations are necessary because this era of the first stars is out of reach for our current telescopes.

The simulation followed the growth of a small, frothing sea of matter fed by four torrents of inflowing gas. While such nodes would have been common in the web of material filling the universe, Whalen says these streams were unusual because they carried so much gas. Latif adds that the rivers of gas were not only dense but fast-flowing; rushing in at speeds of 50 km/s (more than 100,000 mph), they carried between 1 and 10 Suns worth of material per year.

The sea at the center of these streams of material grew, and within the sea a clump took shape, and then another. The turbulence of inrushing gas flows kept the massive clumps from collapsing straightaway into stars; instead, the clumps continued to grow. By the end of the simulation 1.4 million years later they contained tens of thousands of Suns worth of mass.

Eventually, these clumps compress into what the researchers call supermassive stars; following their evolution requires a different kind of computer simulation, one that takes stellar physics into account. The stellar monstrosities dont last long in this simulation, just 1 million years, before they collapse again into black holes of 30,000 and 40,000 solar masses, respectively.

Such massive seeds could easily collect more gas and grow to become the dark behemoths seen by astronomers. Even though the kind of confluence explored in this study is rare, Latif, Whalen, and colleagues estimate that it would occur often enough to explain observations.

The new environment replete with cold flows thats numerically explored in this study is very exciting, says Priya Natarajan (Yale), as it seems to provide a natural pathway for the formation of massive black hole seeds.

But it isnt the only scenario that results in direct collapse, she cautions. Natarajan, who wasnt involved in the current study, explored a different scenario back in 2014, finding that a dense star cluster could similarly allow direct collapse to happen. The upshot isthat there are multiple pathways to rapidly amplifyand make massive black hole seeds in situ and early in the universe.

Upcoming James Webb Space Telescope observations, she adds, will help distinguish between the different black hole seed scenarios. Webb wont be able to detect the supermassive stars, even though theyre millions of times more luminous than the Sun, but its possible it could detect the black hole seeds that are still growing when the universe is less than 200 million years old.

Advertisement

The rest is here:

Where Did the First Quasars Come From? - Sky & Telescope - Sky & Telescope

Posted in Corona Virus | Comments Off on Where Did the First Quasars Come From? – Sky & Telescope – Sky & Telescope

Astronomers discover the fastest star in the known universe – The Independent

Posted: at 9:11 am

Researchers have discovered the fastest star in the known universe.

The star, called S4716, orbits the Sagittarius A black hole in the centre of our Milky Way, located at a distance of 100 AU the distance between the Earth and the Sun from our planet.

The star is packed in an S cluster of over 100 stars known for moving particularly fast.

After observing S4716 for almost 20 years, the scientists have established that it travels around the supermassive black hole, which has a diameter of 23.5 million kilometers, in only four years at a speed of 8,000 kilometres per second.

For a star to be in a stable orbit so close and fast in the vicinity of a supermassive black hole was completely unexpected and marks the limit that can be observed with traditional telescopes, said Dr Florian Peissker, lead author of the new study.

The close-range orbit of S4716 is still puzzling to scientists. Stars cannot form so easily near the black hole. S4716 had to move inwards, for example by approaching other stars and objects in the S cluster, which caused its orbit to shrink significantly, Michael Zajaek, an astrophysicist at Masaryk University in Brno, Czech Republic, who was involved in the study, said.

A total of five telescopes were needed to observe the star, with four of these five being combined into one large telescope to allow even more accurate and detailed observations.

The researchwas published in The Astrophysical Journal.

More:

Astronomers discover the fastest star in the known universe - The Independent

Posted in Corona Virus | Comments Off on Astronomers discover the fastest star in the known universe – The Independent

Kalamazoo Astronomical Society invites the public to stargaze in July – WKZO

Posted: at 9:11 am

KALAMAZOO, MI (WKZO AM/FM) The Kalamazoo Astronomical Society is inviting the public to observe the wonders of the universe at its Owl Observatory in July.

The Observatory features a 16-inch Schmidt-Cassegrain telescope.

In addition, telescopes of all sizes will be set up near the observatory which is located on the grounds of the Kalamazoo Nature Center at 7000 North Westnedge Avenue.

Upcoming observing dates:

Saturday, July 9:The Moon and Double Stars of Summer

Saturday, July 23:Saturn and the Summer Triangle

Observing begins both nights at 9:30 p.m.

Each session will also feature a constellation workshop to help attendees learn to read a simple star map and find bright stars and constellations on their own.

The workshop will be followed by a guided tour of the night sky.

More information can be found at http://www.kasonline.org/

Continue reading here:

Kalamazoo Astronomical Society invites the public to stargaze in July - WKZO

Posted in Corona Virus | Comments Off on Kalamazoo Astronomical Society invites the public to stargaze in July – WKZO

For Now, US Treads Water with Transformed COVID-19 – Voice of America – VOA News

Posted: July 3, 2022 at 3:45 am

The fast-changing coronavirus has kicked off summer in the U.S. with lots of infections but relatively few deaths compared to its prior incarnations.

COVID-19 is still killing hundreds of Americans each day, but is not nearly as dangerous as it was last fall and winter.

"It's going to be a good summer and we deserve this break," said Ali Mokdad, a professor of health metrics sciences at the University of Washington in Seattle.

With more Americans shielded from severe illness through vaccination and infection, COVID-19 has transformed for now at least into an unpleasant, inconvenient nuisance for many.

"It feels cautiously good right now," said Dr. Dan Kaul, an infectious diseases specialist at the University of Michigan Medical Center in Ann Arbor. "For the first time that I can remember, pretty much since it started, we don't have any (COVID-19) patients in the ICU."

As the nation marks July Fourth, the average number of daily deaths from COVID-19 in the United States is hovering around 360. Last year, during a similar summer lull, it was around 228 in early July. That remains the lowest threshold in U.S. daily deaths since March 2020, when the virus first began its U.S. spread.

But there were far fewer reported cases at this time last year fewer than 20,000 a day. Now, it's about 109,000 and likely an undercount as home tests aren't routinely reported.

Today, in the third year of the pandemic, it's easy to feel confused by the mixed picture: Repeat infections are increasingly likely, and a sizeable share of those infected will face the lingering symptoms of long COVID-19.

Yet, the stark danger of death has diminished for many people.

"And that's because we're now at a point that everyone's immune system has seen either the virus or the vaccine two or three times by now," said Dr. David Dowdy, an infectious disease epidemiologist at Johns Hopkins Bloomberg School of Public Health. "Over time, the body learns not to overreact when it sees this virus."

"What we're seeing is that people are getting less and less ill on average," Dowdy said.

As many as 8 out of 10 people in the U.S. have been infected at least once, according to one influential model.

The death rate for COVID-19 has been a moving target, but recently has fallen to within the range of an average flu season, according to data analyzed by Arizona State University health industry researcher Mara Aspinall.

At first, some people said coronavirus was no more deadly than the flu, "and for a long period of time, that wasn't true," Aspinall said. Back then, people had no immunity. Treatments were experimental. Vaccines didn't exist.

Now, Aspinall said, the built-up immunity has driven down the death rate to solidly in the range of a typical flu season. Over the past decade, the death rate for flu was about 5% to 13% of those hospitalized.

Big differences separate flu from COVID-19: The behavior of the coronavirus continues to surprise health experts and it's still unclear whether it will settle into a flu-like seasonal pattern.

Last summer when vaccinations first became widely available in the U.S. was followed by the delta surge and then the arrival of omicron, which killed 2,600 Americans a day at its peak last February.

Experts agree a new variant might arise capable of escaping the population's built-up immunity. And the fast-spreading omicron subtypes BA.4 and BA.5 might also contribute to a change in the death numbers.

"We thought we understood it until these new subvariants emerged," said Dr. Peter Hotez, an infectious disease specialist at the Baylor College of Medicine in Texas.

It would be wise, he said, to assume that a new variant will come along and hit the nation later this summer.

"And then another late fall-winter wave," Hotez said.

In the next weeks, deaths could edge up in many states, but the U.S. as a whole is likely to see deaths decline slightly, said Nicholas Reich, who aggregates coronavirus projections for the COVID-19 Forecast Hub in collaboration with the Centers for Disease Control and Prevention.

"We've seen COVID hospitalizations increase to around 5,000 new admissions each day from just over 1,000 in early April. But deaths due to COVID have only increased slightly over the same time period," said Reich, a professor of biostatistics at the University of Massachusetts Amherst.

Unvaccinated people have a six times higher risk of dying from COVID-19 compared with people with at least a primary series of shots, the CDC estimated based on available data from April.

This summer, consider your own vulnerability and that of those around you, especially in large gatherings since the virus is spreading so rapidly, Dowdy said.

"There are still people who are very much at risk," he said.

Read the original post:

For Now, US Treads Water with Transformed COVID-19 - Voice of America - VOA News

Posted in Corona Virus | Comments Off on For Now, US Treads Water with Transformed COVID-19 – Voice of America – VOA News

Could nasal swabs one day be a thing of the past? Coronavirus research update for July 2, 2022 – cleveland.com

Posted: at 3:45 am

CLEVELAND, Ohio - A new diagnostic test for the coronavirus could make nose and throat swabs a thing of the past, researchers establish the effectiveness of COVID-19 vaccines for obese people, and super immune molecules from llamas may hold the key to outwitting viral mutations.

Heres a summary of some of the latest coronavirus research findings for Saturday, July 2.

A skin patch that detects COVID-19 infection

Researchers in Japan are developing a new coronavirus test that they hope will take the place of unpleasant nose and throat swabs. Its a patch that detects antibodies through the skin.

Results from nasal and throat swab tests are expensive, take a long time (46 hours), and require specialized equipment and training. Alternatively COVID-19 infection can be detected in as little as 20 minutes by measuring antibody levels in the blood - but that requires a blood draw or painful finger stick.

However, a group of scientists from the University of Tokyo have developed a new test that can quickly and accurately detect COVID-19 infection without using any blood at all.

The test uses a skin patch about the size of a Band-Aid with tiny, biodegradable microneedles on one side. The microneedles painlessly draw small amounts of fluid from the skin, and transfers them to a paper-based immunoassay biosensor designed to detect SARS-CoV-2 antibodies .

Researchers say the test delivers results in three minutes, can be adapted to detect antibodies from other diseases, and can be used safely for on-site, rapid screening in a variety of settings. The research was published in the journal Scientific Reports.

Vaccines have demonstrated benefit for people of all body weights

Obesity was identified early on in the pandemic as a risk factor for severe COVID-19. It was previously shown that people with obesity have a slightly reduced benefit from flu vaccines. However, until now, little was known about the effectiveness of coronavirus vaccines for people with obesity.

A new study published in The Lancet Diabetes & Endocrinology shows that vaccines greatly reduced the number of cases of severe COVID-19 disease for everyone regardless of their body size, to different degrees.

The researchers compared risk of severe disease in vaccinated versus non-vaccinated people at least 14 days after receiving their second dose. Over 9 million people were included in the study.

Individuals with healthy or high BMI who were vaccinated were around 70% less likely to be hospitalized than unvaccinated people. People with a healthy or a higher BMI were also around two-thirds less likely to die than their unvaccinated counterparts.

By comparison, vaccinated people who were underweight were found to be 50% less likely to be hospitalized or die form severe COVID-19 infection..

Super immune molecules derived from llamas may provide protection from future viruses

Tiny immune molecules from a llama could provide protection against a vast array of SARS-like viruses, including COVID-19, researchers say.

In a paper published in the journal Cell Reports, the scientist suggest that super-immunity molecules, known as nanobodies, could be precursors to a fast-acting, inhalable antiviral treatment or spray that could potentially be stockpiled and used globally against the evolving pandemic and future viruses.

Llamas, camels, and alpacas have unique immune systems. They produce antibodies that are roughly one-tenth the size of normal ones, are exceptionally stable, and can firmly bind to disease targets.

Researchers discovered that by immunizing a llama against part of the COVID-19 virus, they could produce and isolate these tiny antibodies, called nanobodies, that recognized not just SARS-CoV-2, the virus that causes COVID-19, but a vast array of other coronaviruses. Because of the unique properties of these molecules, researchers can readily link multiple unique nanobodies in a chain, so if a virus attempts to escape by mutating, another nanobody is ready to keep it in check.

Their superior stability, low production costs, and the ability to protect both the upper and lower respiratory tracts against infection mean they could provide a critical therapeutic to complement vaccines and monoclonal antibody drugs if and when a new COVID-19 variant or SARS-CoV-3 emerges, explained the studys lead author Yi Shi in a press release.

While more research is needed, we believe that the broad protection, ultrapotent nanobodies we were able to isolate in the lab can be harnessed for use in humans.

More here:

Could nasal swabs one day be a thing of the past? Coronavirus research update for July 2, 2022 - cleveland.com

Posted in Corona Virus | Comments Off on Could nasal swabs one day be a thing of the past? Coronavirus research update for July 2, 2022 – cleveland.com

Could I catch COVID at an outdoor wedding or picnic? : Goats and Soda – NPR

Posted: at 3:45 am

Print a poster version of this comic to hang up on your fridge or give away to friends. Download the poster here. Malaka Gharib/ NPR hide caption

Print a poster version of this comic to hang up on your fridge or give away to friends. Download the poster here.

Outdoor events are way less risky than indoor events when it comes to COVID. They are still, by far, the safest way to gather as the country continues to see high levels of cases and rising hospitalizations.

But "way less risky" is not "zero risk." There's still a chance of catching COVID even at an outdoor event especially as the virus continues evolving to become more transmissible and to break through prior immunity from vaccination or earlier cases.

"With the more transmissible variants, it's likely that shorter periods of close contact will result in transmission," says Dr. Preeti Malani, an infectious diseases physician and a professor of medicine at the University of Michigan.

That means activities that once seemed pretty safe are potentially riskier and that includes outdoor activities.

As Maimuna Majumder, an assistant professor at Harvard Medical School and a computational epidemiologist at Boston Children's Hospital, puts it, "the more transmissible a variant is indoors, the more transmissible it is in outdoor settings, too."

So additional precautions during a surge like the one the U.S. is currently seeing may be in order particularly if you are vulnerable or are in frequent contact with someone who is, say the experts interviewed for this story.

"People are going to make judgments based on [their] own level of risk and comfort," says Donald Milton, a professor of environmental and occupational health at the University of Maryland School of Public Health.

But, Majumder says, "that transmissibility can be drastically reduced by ensuring that an outdoor event doesn't get too crowded." That means having plenty of room for guests to move around and making sure they are vaccinated, recently tested and symptom-free is also a very good idea, she says.

With the July 4 weekend upon us and wedding season in full swing, experts answered frequently asked questions about staying safe while gathering outdoors with family and friends.

When should guests get tested?

Majumder helped her friend plan a wedding with about 100 attendees, and they have not heard of any resulting cases of COVID.

First, they made sure everything was outdoors, including events that happen around the wedding rehearsal dinners, happy hours and so on.

They reminded everyone to be up-to-date on vaccinations and boosters, which can help prevent transmission of the virus.

They also asked guests to stay home if they were feeling any symptoms.

And everyone agreed to take a rapid test right before the event.

Majumder has thrown other events and parties with similar guidelines, and so far, she's not heard of anyone getting sick.

And for those who still think that you aren't contagious if you're not showing symptoms, a required pre-event test could surprise you.

"There have been multiple instances where folks without symptoms have tested positive, so they've stayed home," says Majumder, who asks everyone to get rapid tested within an hour of her events. She also keeps rapid tests on hand in case someone isn't able to test before they arrive.

Getting tested right before the event is key. Rapid tests are pretty good at telling someone whether they are positive and very contagious at that moment. But their status can change within hours, so if you take a rapid test in the morning, you could be contagious by night.

Rapid tests aren't always foolproof sometimes you have a false negative but they can be a very helpful layer of protection in addition to other precautions.

There have also been times when people felt a bit off and stayed home from one of Majumder's events, only to test positive a day or two later which meant they would have been contagious during the party.

And in addition to monitoring symptoms, Malani says, "if you add testing and vaccination to a low risk outdoor setting, the risk of COVID becomes manageable."

Do the old rules of staying safe still apply once the event gets going?

Keeping a distance still helps enormously. Whether you're having a wedding or BBQ, that might mean putting families together at the same table, rather than mixing them in with other guests, and spacing each table a few feet apart.

The "15-minute rule" was developed for contact tracers to reach out to people who may have been exposed to COVID. If you're in close contact with someone for more than 15 minutes, you're likelier to get sick. But it is also possible to catch the virus in passing, especially indoors.

Australian authorities reported a case last summer where someone got sick after walking by an infected person for a few seconds at a shopping mall, according to video footage.

Whether you get sick all depends on several factors: how much virus a person is emitting, what your immunity level is from vaccination or prior infection and, importantly, how much fresh air is between you.

Where do masks fit in?

When it comes to COVID, the outdoors are great for two main reasons: there's plenty of fresh air outside, and you have more space to keep a distance, Milton says.

But if you're not able to keep a distance in a crowd at a concert, sporting event or protest, for instance masking up greatly reduces the risks of getting sick.

That's especially true if people are shouting and yelling, if you're near them for a long period of time and if you don't know their vaccination, test and symptom status.

"If you're close together, you're likely to share air with other people," says Milton.

Two of his colleagues believe they caught COVID outdoors early in the pandemic one at an outside brunch, and one who was waiting in line to pick up groceries in spring 2020.

"There's always been a risk outdoors," Milton says. "It's much lower [than indoors], but it's not nothing."

The closer you are physically to someone, the higher the risk. If you're close enough, say, to smell on their breath what they chose for dinner, you're close enough to inhale the viral particles on their breath.

There is also the off-chance of air blowing the wrong way.

Just like plumes of smoke, virus-laden exhalations can "travel the distance outdoors," Milton says. That means it's possible to get infected even if you're not right next to someone.

But the chances of getting COVID at a distance outdoors are significantly lower than pretty much any other form of interaction, such as talking closer together or meeting indoors.

"I think the most important thing to remember about the outdoors is that while it's safer, it's not 100% safe," Majumder says. "The more crowded an outdoor space is, the more it begins to mimic an indoor space in terms of our exposure to shared air."

But, she says, "I don't think masks are necessary while outdoors as long as the event isn't too crowded, everyone tested negative, no one is experiencing symptoms and everyone is up-to-date on their vaccinations."

What if we need to go inside during an outdoor event?

Even if your event is outside, people may need to go indoors briefly to use the bathroom or wash their hands "something I think many folks forget when planning an event," Majumder says.

Guests should wear a high-quality mask, like an N95 or KF94, anytime they need to dash inside. Hosts can keep masks "stocked and accessible" for any of these indoor forays, Majumder says.

"Masks remain very important and very effective," Malani says. Especially if you or a member of your household is high risk, "keep masks handy not so much for outdoor use, but when you go in and out."

(You can also improve ventilation and filtration indoors by opening doors and windows and running air purifiers in bathrooms or hallways.)

Outdoor tents that don't have side flaps enclosing the space can help protect from the sun or rain while allowing air to pass through. But "if the tent is enclosed, it's not that different than being indoors," Milton says.

And "sometimes, social gatherings end up moving indoors," Malani points out, because of bad weather, high or low temperatures, or annoying mosquitoes and "that's when transmission risk can go from low to high."

Should I invite people from out of town?

The nature of a big event with lots of out-of-town guests is a recipe for transmission when cases are high. Guests are likely to fly in, stay in hotels that may not have good ventilation, eat inside restaurants and meet up with family and friends. Even if the event that you're hosting is itself low-risk, these other activities may not be.

And "the larger the group, the higher the risk," Malani says, because there are more chances of someone having the virus and passing it on.

"Prevention means using a layered approach," she says. Try to take as many precautions as possible distancing, staying home if you're sick, testing and masks when needed.

When those measures are taken, she says, "being outdoors is a wonderful way to spend time together."

Melody Schreiber (@m_scribe) is a journalist and the editor of What We Didn't Expect: Personal Stories About Premature Birth.

Visit link:

Could I catch COVID at an outdoor wedding or picnic? : Goats and Soda - NPR

Posted in Corona Virus | Comments Off on Could I catch COVID at an outdoor wedding or picnic? : Goats and Soda – NPR

What it’s like to catch the coronavirus for the sake of science – Los Angeles Times

Posted: at 3:45 am

On a cold, damp Monday just over a year into the pandemic, Jacob Hopkins tilted his head back in a London hospital and did something no other human had ever done before: He allowed five doctors in full hazmat garb to dribble into his nostrils a precisely calibrated suspension of the coronavirus that causes COVID-19.

Hopkins would go on to become one of the more than 546 million people across the globe to be infected with the virus known to scientists as SARS-CoV-2.

He did it for science.

Hopkins was the first of 36 healthy young Britons to participate in a human challenge study of the most consequential virus on the planet. The experiment was widely accepted in the United Kingdom as an efficient way to gain insights into how, where and for how long the virus establishes itself in people.

Knowing the minute details of a coronavirus infection is critical to vaccine and drug designers, to public health officials, and to those caring for patients. Many of those details remained elusive until the studys findings were published this spring.

Jacob Hopkins rests his arm near vials of blood that were drawn to study what the coronavirus does inside the body.

(Jacob Hopkins)

Hopkins had only a fuzzy sense of how his act might help others. As a teenager, he had responded to a cousins leukemia by signing up with a stem cell registry, and ended up donating bone marrow. This time, he hoped his participation might speed the development or testing of vaccines for low-income countries.

I would have been devastated if I couldnt take part, he said.

In the United States, deliberately infecting humans with the coronavirus was so controversial that American officials declared it a last resort. They argued that scientists could find ways to unlock the virus secrets without exposing volunteers to even a tiny risk of death.

Human challenge studies were Plan D, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, who contemplated them only as a way to put a new vaccine through its paces.

Newsletter

Get our free Coronavirus Today newsletter

Sign up for the latest news, best stories and what they mean for you, plus answers to your questions.

Enter email address

Sign Me Up

You may occasionally receive promotional content from the Los Angeles Times.

Experiments that intentionally expose healthy volunteers to serious harm pose deep quandaries. Thats especially true when too little is known about a virus to predict its impact, and when effective treatments arent available.

But in the next pandemic, or even later in this one, some U.S. scientists say they may rethink their resistance.

We can learn things more quickly by doing challenge studies, said Dr. Stanley Plotkin, a University of Pennsylvania vaccinologist who was a leading voice in calling for such research.

When an infectious disease is spreading out of control, saving time may be worth the risk, said Arthur L. Caplan, a bioethicist at New York University.

If volunteers were willing to be infected, you could prevent potentially millions of deaths, he said.

::

Jacob Hopkins took this selfie while he was participating in a human challenge trial to help scientists learn more about SARS-CoV-2.

(Jacob Hopkins)

Jacob Hopkins path to becoming a human guinea pig wasnt particularly fraught. He had always been fit, he said, and volunteering felt like something I could do.

Hopkins was a 22-year-old history student at Newcastle University when Britain imposed the first of several strict lockdowns. He went home to live with his parents in Birmingham after his school closed.

In the final months of 2020, Hopkins was working in a grocery store and scrolling through his social media feed when he saw an ad with pictures showing attractive people masked and socially distanced, but otherwise equipped with the usual accoutrements of young adulthood backpacks, schoolbooks and earbuds.

Help us fight COVID-19, said the advertisement. Stripped across the bottom, in fine print, was a disclaimer: You may suffer COVID-19 symptoms if you take part.

It seemed like a way to help the world get back to normal faster. Hopkins first love, backpacking abroad, was not an option. Nor was socializing at home. His studies in Cold War history had been put on hold. But the prospect of playing some small role in this historical moment gave him a sense of mission.

In fact, hands shot up across the world. Hopkins was one of nearly 37,000 people who expressed initial interest in participating in the study. Researchers screened 6,135 by phone, winnowing the unresponsive, the unsure and those who were too old or too sick. With 187 potential candidates left, they pruned people whod become infected, lost interest or had gained access to vaccine. Thirty-six, including Hopkins, were deemed healthy, stable, ready to go.

His parents were definitely not happy, Hopkins said. But he was determined to see it through. While his countrymen were letting down their guard after a third round of lockdowns, Hopkins double- and triple-masked when in public. If he got infected before the study began, hed be disqualified.

I never wanted to get COVID, Hopkins said, and then quickly corrected himself. Well, I did want COVID, but I wanted it at the right time.

::

In the U.S., scientists at the National Institutes of Health took a step toward launching a human challenge trial early in the pandemic. The government ordered up SARS-CoV-2 viral samples that could be used to deliver precise, genetically identical doses to human subjects.

But that, Fauci told CNN at the time, was an absolutely far-out contingency.

He stands by that decision nearly two years later. Even if researchers had an urgent need to test a new vaccine, they could do so without infecting volunteers because the coronavirus is readily available in the world at large, he said in an interview.

Plotkin was among the scientists who lobbied the NIH to conduct a human challenge trial. He said officials were concerned that a volunteer would be harmed and that if that happened, the reputation of the NIH would be harmed.

The British, by contrast, were interested right from the beginning, he said.

A daytime view of London from Jacob Hopkins hospital room.

(Jacob Hopkins)

The United Kingdom was uniquely positioned to move ahead quickly with a human challenge study. The National Health Service provides care for all Britons, so participants medical and mental health histories are readily available. Its universal healthcare system also means that research subjects would never be refused follow-up care if something went awry. (Neither is the case in the U.S.)

British researchers had a long tradition of studying infectious diseases including influenza, common cold viruses and malaria using controlled human infection models. The practice came of age in 1946, when Britain repurposed a wartime hospital in Salisbury as a Common Cold Research Unit.

Compensation was the principal inducement for participation, and it remained that way for decades. Healthy people with time on their hands could spend a couple of weeks in what was sometimes billed as Flu Camp. Theyd depart well-fed and rested, with some cash in their pockets.

With the COVID-19 study, it was clear that volunteers motives were overwhelmingly altruistic, said Carol Dalton, a spokeswoman for hVIVO, the clinical research company that carried out the COVID-19 study with scientists from Imperial College London. Participants earned 4,565 British pounds (about $5,500) for a 17-day hospital stay and several follow-up visits, though the pay was not a prominent feature of the hVIVO advertisements.

Separately, more than 38,000 people reached out to 1DaySooner, an online clearinghouse for people willing to participate in human challenge studies. Hopkins signed up on that website, as well as on the studys official enrollment site.

There was no precedent for so many volunteers asking scientists to put their own health at risk in such a trial, said Abie Rohrig, a student of bioethics at Swarthmore College who helped set up 1DaySooner.

::

One of Jacob Hopkins meals during his hospital stay.

(Jacob Hopkins)

Hopkins took that risk in stride. He said he understood he was taking a chance, but he was more concerned about developing long COVID, an array of lingering post-infective symptoms, than he was about catching COVID-19 itself.

As he anticipated spending weeks holed up in St. Marys Hospital in Londons Paddington quarter, he had high hopes for using his time well. He thought he might learn British sign language online and stream some movies for fun.

But the schedule didnt leave much time. Participants started each day in front of a laptop, churning through a battery of odious cognitive tests. There was also a daily scratch-and-sniff smell test and the hour he spent with his face buried in a plastic mask that measured his respiratory output. Research staff, often unrecognizable under layers of protection, were in and out of his room all day taking vital signs and drawing blood.

Meals were tasty but spartan. A bag of crisps showed up on his tray once or twice, prompting great excitement.

Strictly isolated in his hospital room, he gazed out the window at the London Eye, the citys famous Ferris wheel, and lost himself in the reassuring nostalgia of classic video games like The Sims and Ratchet & Clank.

On two occasions, Hopkins was bundled into his own hazmat suit and wheeled to a CT scanner. Those days were rare treats, when we were seeing something other than the four walls of a very sterile room, he said.

Getting the study underway took a year of debate and preparation. By the time British scientists deliberately infected Hopkins on March 2, 2021, several COVID-19 vaccines were beginning to go into arms across the United Kingdom. It was a milestone but it threatened to derail the human challenge study, which had been intended to help with vaccine development.

We had to completely rethink what this study was for, said Dr. Christopher Chiu, an immunologist and infectious disease specialist who led the team from Imperial College London. With so much still unknown about the virus, there was still a public health need, Chiu said. And researchers testing antiviral medications would still need to know how much virus it took to seed an infection.

So the aim was recast. The trial would identify the exact dose at which an exposure to SARS-CoV-2 virus would infect half of healthy young people. And it would track the coronavirus behavior and its interaction with its hosts across the length of infection.

The studys findings were reported this spring in the journal Nature Medicine.

Among its insights:

Even at the lowest concentration measurable in a lab, SARS-CoV-2 virus established a beachhead in the throats of just over half of the young, healthy subjects within two days.

The viral loads in their noses reached peak concentration an average of five days after exposure.

Whether or not subjects developed COVID-19 symptoms, they were capable of infecting others for an average of five more days.

None of the infected became seriously ill, but 83% lost their sense of taste or smell; in most cases, it returned slowly over three months. None experienced lung damage.

The findings made powerfully clear that young people have been potent drivers of pandemic spread. Further analysis of the findings is expected to yield insights into how the immune system resists infection, and why some people become infected while others do not.

So were these insights worth the risk taken by Hopkins and his fellow volunteers?

Chiu, the senior author of the paper detailing the studys findings, thinks so.

Theres unique strength to the findings from this kind of study, Chiu said. You capture every part of infection from the point of exposure to the end.

In the U.S., Caplan said he was frustrated that so much of the medical establishment was wary of allowing healthy Americans to be deliberately infected, when doing so could have yielded lifesaving insights.

People who sign up for such experiments must never be compelled to do so, Caplan said, nor induced with extravagant rewards. But people in many walks of life from test pilots and deep-sea divers to virologists who collect bat guano from caves take risks for science, he said. Every day, regular folks volunteer for early clinical trials of experimental drugs, where the correct dose is unknown and its safety is still very much in question.

Its a noble thing to do, he said, adding that many Americans wanted to do it: We knew because wed been asked.

::

This hospital room was Jacob Hopkins home for 17 days while he weathered a case of COVID-19 for the sake of science.

(Jacob Hopkins)

Hopkins said hed do it again, in a heartbeat.

Though the virus plunged him into a two-day ordeal of feeling rubbish, it was an enormous relief to realize he had become infected. After the tests he endured to get into the study, and after fending off so many COVID-19 surges, he finally had something to offer. He high-fived one of the doctors who dribbled virus down his nose.

During his entire bout, researchers tracked hour by hour the rise and fall of his vital signs, his viral loads, his altered cognitive state and his immune systems strenuous effort to clear the virus.

Column One

A showcase for compelling storytelling from the Los Angeles Times.

When at last it did after 17 days, Hopkins received a check for 1,535 British pounds (nearly $1,900); the remainder was held in reserve pending follow-up visits.

All I did was sat in a room, said Hopkins, who now counsels low-income Britons on how to secure access to nutritious food. But I was so proud and happy to be a part of this. I was really part of something special.

On his last day at the hospital, as Hopkins slung his rucksack over his shoulder and marched toward the exit, the men and women who had taken his vital signs, delivered his meals and monitored his progress showed up to applaud him.

It was a heros farewell.

Read the rest here:

What it's like to catch the coronavirus for the sake of science - Los Angeles Times

Posted in Corona Virus | Comments Off on What it’s like to catch the coronavirus for the sake of science – Los Angeles Times

Page 12«..11121314..2030..»