Monthly Archives: April 2021

For Immediate Release: April 01, 2021

Today, the U.S. Food and Drug Administration announced two revisions regarding the number of doses per vial available for the Moderna COVID-19 Vaccine. The first revision clarifies the number of doses per vial for the vials that are currently available, in that the maximum number of extractable doses is 11, with a range of 10-11 doses. The second revision authorizes the availability of an additional multi-dose vial in which each vial contains a maximum of 15 doses, with a range of 13-15 doses that can potentially be extracted.

Both of these revisions positively impact the supply of Moderna COVID-19 Vaccine, which will help provide more vaccine doses to communities and allow shots to get into arms more quickly. Ultimately, more vaccines getting to the public in a timely manner should help bring an end to the pandemic more rapidly, said Peter Marks, M.D., Ph.D., director of the FDAs Center for Biologics Evaluation and Research.

Depending on the type of syringes and needles used to extract each dose, there may not be sufficient volume to extract more than 10 doses from the vial containing a maximum of 11 doses or more than 13 doses from the vial containing a maximum of 15 doses.

To support these changes to the emergency use authorization, the FDA evaluated data showing the number of doses that could be extracted from the vials and on the fill volumes for both vials that were submitted by ModernaTX, Inc. The Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Prescribing Information have been revised to reflect the new information and are intended to help frontline workers administering COVID-19 vaccines understand the number of doses that can potentially be extracted per vial.

Because the Moderna COVID-19 Vaccine does not contain preservative, any further remaining product that does not constitute a full dose should not be pooled from multiple vials to create one full dose. If one vial becomes contaminated during use, pooling doses from multiple vials can spread contamination to other vials. Use of contaminated vials may cause serious bacterial infections in vaccinated individuals. The updated information in the revised Fact Sheet for Vaccination Providers and Prescribing Information provides instructions to not pool vaccine from multiple vials.

The dosing regimen remains unchanged; the vaccine is administered as a two-dose series, 0.5 mL each dose, one month apart.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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04/01/2021

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Coronavirus (COVID-19) Update: FDA Makes Two Revisions to Moderna COVID-19 Vaccine Emergency Use Authorization to Help Increase the Number of Vaccine...

By: Francisco R. Velzquez, M.D., S.M.

Organisms in general, be it humans, plants, insects, bacteria, or viruses, undergo genetic mutations which can be beneficial or detrimental. Although viruses are not technically alive, these also mutate and evolve as they infect a hosts cell, replicate and move on to another cell or a new host. The process by which a virus spreads is what we call transmission. There are differences in the rates of mutations amongst different types of viruses. As an example, the SARS-CoV-2 coronavirus which causes the clinical entity we know as COVID-19 mutates approximately every 11-15 days. That is about half of the rate of influenza (flu) and about a quarter of the HIV rates. Mutations generate variability within a population, which allows natural selection to amplify traits that are beneficial, in this case, to the viral particle, as viruses are not considered organisms per-se.

We know the coronavirus currently has 12,700 identified mutations, 12 main types of the virus (identified as 19 A, the original type, through 20 J), five strains and almost 4000 variants. The strains are known as L, the original strain, which mutated into the S strain followed by V and G (further mutating into GR, GH and GV, and several infrequent mutations collectively grouped together as O). The G strains are now the dominant strain around the world. SARS-CoV-2 variants with spike (S)-protein D614G mutations have become the most common variant. It is so named because one amino acid is changed from a D (aspartate) to a G (glycine) at position number 614 of the viral spike proteins. The spike protein mediates the binding to the target receptors and the fusion to the human cell membrane. The S protein extends from the viral membrane giving the virus surface a crown-like appearance, for which the virus is named; corona is crown in Latin. Most of the variants of concern contain mutations in the receptor-binding domain (RBD). It seems these mutations are responsible for increased viral infectivity, virulence, and immune evasion potency. It is known that the RBD is involved in viral recognition and cell receptor binding and interaction, thus any structural changes seem to be directly related to viral transmissibility and virulence. It has also been identified in numerous studies that antibodies developed against the RBD have been found to have maximum potency against the SARS-CoV-2.

It all starts in the coronavirus RNA genome, which is composed of 30,000 nucleotides, the basic structural unit of nucleic acids. The best way to think about it is as an alphabet of 30,000 letters that spell the sequences for 29 genes. The virus itself is a coil of genetic material in a protein shell with an outer envelope most of the time. The virus binds to a human target cell receptor, injects its genetic material, and takes over the cell, turning into a virus replicating factory. As it replicates, mutations can take place and either help or compromise the virus. Many of the identified mutations are inconsequential as these do not change the biology of the virus. Mutations are passed down through lineage, best described as a branch in the family tree. A group of coronaviruses that have the same inherited set of very distinctive mutations is called a variant. The lineage becomes known as a strain, and in this specific example, COVID-19 is caused by a coronavirus strain known as SARS-CoV-2. Through the course of the pandemic, we have identified several variants globally, five of which are of concern as the strains are associated with higher transmission rates that may impact the effectiveness of vaccine and therapy, and it seems increased mortality may be associated with at least one variant. More recently there have been several variants identified in the United States that share some mutations with the more aggressive variants initially identified in other countries.

The first step in understanding the variants and the impact these have in infection, reinfection and possible effects on vaccines and treatments is knowing the mutations. Although there are thousands of mutations for the most part, thus far, seven of those are the most critical to know.

The D614G Spike mutation was the first mutation of concern identified in China early in the pandemic. This mutation quickly spread around the world allowing the mutated viruses to rapidly replace strains without the mutation. Although it seemed to increase the infectiousness, it was not associated with more severe disease or reduced vaccine effectiveness.

The first variant-associated mutation seen in Europe is known as A222V, identified in the B.1.177 (20A.EU1) variant that originated in Spain and dominated the European landscape for months. We do not hear much about it, because it has not been associated with increased transmission.

More of concern are the next five mutations identified. First is the N501Y Spike mutation which has been identified in at least three variants of concern. Found at the tip of the Spike protein, this mutation seems to cause a tighter thus more effective fit to the human cell receptors.

The E484K Spike mutation is of significant concern as it has been identified not only in three of the global variants, but also in the newly described American variants. It has been observed in vitro that this mutation alters the shape of the proteins in the viral spike which can potentially mask the antigenic portion from antibodies. There has been much speculation as whether this mutation may impact the effectiveness of monoclonal antibody treatments and cause reinfection in some patients.

The next mutation, although infrequent in the United States, has been associated with many cases in California. L452R has triggered the emergence of numerous global variants and is present in the two recently identified California variants which also carry other mutations. The L452R mutation might enhance the interaction between virus and host cell, which in turn may significantly increase viral transmission and virulence. It may also reduce the virus-neutralizing ability of antibodies specifically targeting the spike RBD.

The sixth is the K417N/T mutation located on the tip of the spike protein, an area important to the antibody recognition process. In some experiments the K417N/T mutation has been associated with decreased antibody recognition and possible resistance to some antibodies. The possibility of a more effective virus/cell binding process has also been described.

More recently the Q677 mutation has been described in at least seven lineages initially identified in Louisiana and New Mexico. Its now in seven states, mainly in the south central and southeast United States. This mutation is four amino acids away from the S1/S2 cleavage site, an area where other mutations have been identified in the more infectious strains. It is unclear currently whether this mutation increases transmission rates.

The centers for Disease Control have defined three different levels of threat associated with variants. These are variants of interest (B.1.526, B.1.525 and P.2), variants of concern (B.1.1.7, P.1, B.1.351, B.1.427 and B.1.429), and variants of high consequence. In the U.S. we have identified the first two categories only. For the variants of concern there is evidence of increased transmissibility, more severe disease and reduced therapeutic effectiveness. Currently, globally-identified variants have been detected in multiple states. First identified in the United Kingdom is the variant known as B.1.1.7, now present in at least 90 countries and 51 states including Washington. This variant accumulated a high number of mutations including several in the spike protein. Of the 17 identified, the most notable is the N501Y mutation which has been found to help the virus form a tighter attachment to the ACE2 receptors. This variant is approximately 50% more infectious than the wild type of virus and is estimated to be doubling in the U.S. every 10 days.

Just as the B.1.1.7 variant was being identified, another variant with the same type of N501Y mutation was identified in South Africa. This variant is known as B.1.351 and contains additional mutations such as the K417N, and of more concern the E484K mutation. The latter has been identified in 48 countries and 30 states including Washington. In vitro studies have suggested a potential for a blunted immune response, and a small impact on vaccine efficacy.

A variant that originated in Brazil was first reported in Japan, as it was identified on four people screened upon arrival at an airport outside of Tokyo. It is postulated that the travelers acquired the variant known as P.1 while in Brazil where the lineage is traced back to the city of Manaus, the largest city on the Amazon region. This variant has 17 unique mutations in the spike protein that include the N501Y, E484K and K417N previously discussed. It has been identified in at least 25 countries and 22 states, including Washington. Of particular concern is the anecdotal reports of reinfection in people who had recovered from disease.

Several other variants have been identified in the U.S. over the past several months. One of these variants with the L452R mutation was identified in California and is considered a variant of concern. The variant designated as CAL.20C has two forms: the B.1.427 and B.1.429. It is believed to cause a stronger attachment that may prevent neutralizing antibodies from interfering with the attachment process. Additional work is needed in determining the impact this has in transmissibility, and disease severity.

The B.1.526 and B.1.525 Variants identified in New York and traced back to Washington Heights, a Manhattan neighborhood, the B.1.526 variant has two types: one with the E484K spike mutation which may blunt the antibody response and another with the S477N mutation that may increase the effectiveness of the attachment process. The E484K mutation is also present in the Brazilian and South African variants. These, in addition to the P.2 identified in Brazil, are currently classified as variants of interest.

In the Midwest, specifically in Columbus, Ohio, two novel SARS-CoV-2 clade 20G variants have been identified. The predominant variant has several mutations, including the Q677H and has been identified in several states in the upper Midwest. It is referred to as the Midwest variant. Subsequently, a second variant with the S N501Y mutation, which is a marker of the B.1.1.7, but lacking all other mutations associated with that strain has been identified. This mutation has also been associated with the South African variant. It will be important to further determine what impact these variants will have in the overall pandemic pattern.

It is important to remember that what most of these variants have in common is a more effective transmission pattern, which has been associated with a surge in infections in various areas of the world. In addition, some data suggest that increased morbidity and perhaps mortality can be associated with some of the variants. The impact on treatment and vaccines is still being determined, although preliminary data points to minimal impact on vaccine efficacy. Moreover, vaccine manufacturers have significant capabilities in the reformulation of vaccines.

We also know the transmission mode is the same as with the wild-type (unchanged) coronavirus, thus preventing infection should follow a similar public health guidance: facial coverings, social distancing, avoiding gatherings, and practicing appropriate hygiene and sanitation. These simple rules along with increased immunization and appropriate levels of testing continue to be the key pillars in our management of the pandemic.

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Coronavirus Mutations and Variants: What Does It Mean? - Spokane Regional Health

DETROIT The number of confirmed cases of the coronavirus (COVID-19) in Michigan has risen to 678,295 as of Thursday, including 16,141 deaths, state officials report.

Thursdays update includes a total of 6,036 new cases and 49 additional deaths, including 33 from a vital records review. On Wednesday, the state reported 672,259 total cases and 16,092 deaths.

Testing has been steady around 35,000 diagnostic tests reported per day on average, with the 7-day positive rate above 13.5% as of Thursday, the highest since early December. The state has reported an up-tick in hospitalizations over the last several weeks.

Related: Michigan COVID hospitalizations: Concerns grow as more younger adults are in ICU

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Michigans 7-day moving average for daily cases was 5,061 on Thursday -- the highest since December. The 7-day death average was 26 on Thursday and has been flat for several weeks. The states fatality rate is 2.4%. The state also reports active cases, which were listed at 94,500 on Thursday -- the highest its been since mid-January.

More than 569,000 have recovered from the virus in Michigan.

Michigan has reported more than 4.4 million doses of the COVID-19 vaccine administered as of Wednesday, with 34.5% of residents having received at least one dose.

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More: Whitmer says Michigan plans to combat rising COVID cases with masks, vaccines -- not new restrictions

According to Johns Hopkins University, more than 30.5 million cases have been reported in the U.S., with more than 553,000 deaths reported from the virus.

Worldwide, more than 129.7 million people have been confirmed infected and more than 2.8 million have died. More than 72 million have recovered, according to Johns Hopkins University. The true numbers are certainly much higher, because of limited testing, different ways nations count the dead and deliberate under-reporting by some governments.

Michigan COVID-19 vaccinations: How to find appointments, info on phases

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Coronavirus headlines:

VIEW: Tracking Michigan COVID-19 vaccine doses

VIEW: Tracking coronavirus cases, outbreaks in Michigan schools

Gov. Gretchen Whitmer released a statement Tuesday after White House officials announced that there will increase COVID-19 vaccine doses available for Michigan starting next week.

According to a press release, next weeks shipment will increase by 66,020 bringing the total number of doses to 620,040 -- a weekly record for the state. Officials said the allocation includes 147,800 doses of the single-dose Johnson & Johnson vaccine.

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This comes after Whitmer recently requested for more vaccines as the state is seeing a rise in COVID numbers.

The CDC said that Michigan is leading the country in new cases of COVID-19 per population.

On Tuesday, officials reported 5,177 new COVID cases and 48 additional deaths, including 20 from a Vital Records review. On Monday, the state reported 660,771 total cases and 16,034 deaths.

Local 4s Dr. Frank McGeorge said hes seen a very clear increase in COVID patients at the hospital where he works.

Many of them need to be hospitalized. I would honestly say, this feels worse to me here in Southeast Michigan than it was during the wave that started in November. Now, the most concerning trend is the number of middle-aged people with severe COVID, McGeorge said.

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All Detroiters 16 and older are now eligible for a COVID-19 vaccine, the city announced Monday.

Any Detroit resident age 16 or older can now call to schedule an appointment to be vaccinated at the TCF Center.

Appointments can be made by calling 313-230-0505. Anyone living outside of the city of Detroit, but reporting to work each day in the city, also are eligible to schedule an appointment.

Johnson & Johnson vaccine site opened at Northwest Activities Center 9-1 this Saturday.

Chief Public Health Officer Denise Fair also announced that the Detroit Health Department has been informed it will receive its first allocation of Johnson and Johnson vaccine this week. Detroiters wanting the one dose J&J vaccine can call 313-230-0505 for an appointment to receive at the Northwest Activities Center, located at 18100 Meyers from 9-1 this Saturday.

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The state of Michigan announced Friday that all residents age 16 and up will become eligible for the COVID-19 vaccine on April 5, nearly a month before the May 1 date pledged by President Joe Biden.

People age 16 to 49 with certain medical conditions or disabilities will qualify starting March 22, when 50- to 64-year-olds can begin getting shots under a previous announcement. Two days later, March 24, a federally selected regional mass vaccination site will open at Detroits Ford Field to administer an additional 6,000 doses a day for two months.

Learn more here.

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MORE: Michigans updated COVID-19 vaccination schedule: Who is eligible and when

The Michigan Department of Health and Human Services announced that the first case of the COVID-19 variant B.1.351 has been identified in a child in Jackson County.

The health department did not say how the boy was infected but a case investigation is underway to determine close contacts and if there are additional cases associated.

This new variant was originally detected in South Africa in October 2020 and shares some mutations with the B117 variant. The first case of the B117 variant -- originally detected in the United Kingdom -- was identified in Washtenaw County.

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The state of Michigan has loosened its COVID-19 restrictions on bars and restaurants, including the capacity limit and nightly curfew.

On Tuesday, March 2, Gov. Gretchen Whitmer and the Michigan Department of Health and Human Services announced the restrictions on indoor dining have been revised.

Starting Friday, March 5, Michigan restaurants and bars will be allowed to fill up to 50% capacity, with a maximum of 100 people, according to the state.

Im proud that we are able to take this positive step without compromising public health, Whitmer said.

Since Feb. 1, restaurants had been capped at 25% capacity. From mid-November through the end of January, no indoor dining was allowed at bars or restaurants.

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The number of the confirmed cases of a more contagious COVID-19 variant in Michigan increased by more than 100 this week, suggesting there is undetected spread in the community.

Dr. Joneigh Khaldun, the chief medical director for the Michigan Department of Health and Human Services, said the state has confirmed 422 cases of the COVID-19 B117 variant.

That number increased from 314 cases identified as of six days prior (Feb. 24).

Through a partnership with SMART, Macomb County is offering a new vaccination location in Sterling Heights.

The vaccination site is at the Sterling Heights Senior Center on Utica Road, between Schoenherr and Van Dyke roads.

Appointments are required. Eligible residents and workers can call the SMART Macomb Vaccine line at 586-421-6579.

Wayne County announced it will open several vaccination clinics for residents 65 and older.

According to county Executive Warren Evans, the vaccination clinics will begin Feb. 23.

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Im pleased Wayne County is now in a position to begin vaccinating seniors, Evans said. I know everyone is eager to safely get back to normal. Our team is working hard to ensure all of our residents can get their COVID shot as quickly as the vaccine is available.

There are no walk-up appointments and seniors must make an appointment by calling the number for the site in their communities.

The full list of clinics and how to register can be found here.

Michigan COVID-19 daily reported cases since March 1:

March 1 -- 785 new cases

March 2 -- 1,067 new cases

March 3 -- 1,536 new cases

March 4 -- 1,526 new cases

March 5 -- 1,486 new cases

March 6 -- 1,289 new cases

March 7 -- 980 new cases

March 8 -- 980 new cases

March 9 -- 954 new cases

March 10 -- 2,316 new cases

March 11 -- 2,091 new cases

March 12 -- 2,403 new cases

March 13 -- 1,659 new cases

March 14 -- 1,571 new cases

March 15 -- 1,572 new cases

March 16 -- 2,048 new cases

March 17 -- 3,164 new cases

March 18 -- 2,629 new cases

March 19 -- 3,730 new cases

March 20 -- 2,660 new cases

March 21 -- 2,400 new cases

March 22 -- 2,401 new cases

March 23 -- 3,579 new cases

March 24 -- 4,454 new cases

March 25 -- 5,224 new cases

March 26 -- 5,030 new cases

March 27 -- 4,670 new cases

March 28 -- 4,101 new cases

March 29 -- 4,101 new cases

March 30 -- 5,177 new cases

March 31 -- 6,311 new cases

April 1 -- 6,036 new cases

Michigan COVID-19 daily reported deaths since March 1:

March 1 -- 6 new deaths

March 2 -- 24 new deaths (12 from vital records)

March 3 -- 5 new deaths

March 4 -- 37 new deaths (29 from vital records)

March 5 -- 10 new deaths

March 6 -- 56 new deaths (48 from vital records)

March 7 -- 2 new deaths

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Coronavirus in Michigan: Heres what to know April 2, 2021 - WDIV ClickOnDetroit

For Immediate Release: March 31, 2021

Following recent U.S. Food and Drug Administration actions to support test development, the FDA took swift action this week to get more tests for screening asymptomatic individuals on the market. Today, the agency authorized several tests for over-the-counter (OTC) use without a prescription when used for serial screening. In addition to the tests authorized for OTC use, one serial screening test was authorized for use in a point-of-care (POC) setting without a prescription, and an additional screening test was authorized for POC use with a prescription. The addition of the OTC and POC tests for screening will give schools, workplaces, communities and others several options for serial screening tests that are accurate and reliable. These authorizations follow the FDAs recent actions to advance OTC and other screening test development.

Screening testing, especially with the over-the-counter tests authorized today, is an important part of the countrys pandemic responsemany schools, workplaces, communities, and other entities are setting up testing programs to quickly screen for COVID-19. With the FDAs authorization of multiple tests, the public can be assured these tests have met our scientific standards for emergency use authorization. As weve said all along, if its a good test, well authorize it, said Jeff Shuren, M.D., J.D., director of the FDAs Center for Devices and Radiological Health. The FDA has taken many steps to support test development throughout the pandemic, including authorizing tests quickly, offering many avenues for test developers to work with us to get their tests on the market, if shown to be accurate and reliable, and issuing enforcement policies for COVID-19 tests. As the pandemic has progressed, we have worked with test developers wishing to add screening claims.

In total, the FDA has authorized three tests with serial screening claims (testing asymptomatic individuals multiple times on a routine basis). Specific tests authorized this week:

These tests had been previously authorized by the agency (some under different names) to test those with COVID-19 symptoms, but the actions this week authorize testing of asymptomatic individuals when used for serial testing.

These authorizations follow the agencys multiple steps to streamline the process for test developers interested in authorization for screening with serial testing to increase consumer access to testing, as well as information the FDA has issued to help schools, workplaces, communities, and others establish screening programs.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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03/31/2021

Originally posted here:

Coronavirus (COVID-19) Update: FDA Continues to Advance Over-the Counter and Other Screening Test Development - FDA.gov

MinnPost provides updates on coronavirus in Minnesota Sunday through Friday. The information is published following a press phone call with members of the Walz administration or after the release of daily COVID-19 figures by the Minnesota Department of Health.

Here are the latest updates from April 1, 2021:

Twelve more Minnesotans have died of COVID-19, the Minnesota Department of Health said Thursday, for a total of 6,860.

Of the people whose deaths were announced Thursday, five were in their 80s, two were in their 70s, four were in their 60s and one was in their 40s. Four of the 12 people whose deaths announced Thursday were residents of long-term care facilities.

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MDH also said Thursday there have been 521,667 total cases of COVID-19 in Minnesota. That number is up 2,138 from the total announced on Wednesday and is based on 43,117 new tests. The seven-day positive case positivity rate, which lags by a week, is 5.4 percent. That rate has been increasing for weeks and is above a 5-percent threshold state officials consider a concerning sign of disease spread.

As of Tuesday, the most recent day of data available, 1,682,545 Minnesotans, or 30.2 percent of the population, have received at least one dose of a COVID-19 vaccine. Thats up 24,369 from data reported the day prior. For tips on scheduling a vaccine appointment, consult the Minnesota Vaccine Hunters Facebook group, Vaccine Spotters Minnesota site or sign up for Vaccine Spotters alert notifications on Twitter. Fairview is now vaccinating anyone 50+, those with certain disabilities or health conditions and communities of color. More information can be found here.

Hospitalizations continue to rise. The most recent data available show 105 Minnesotans are hospitalized in intensive care with COVID-19, which is up from 102 in data reported Wednesday and up from 93 last Thursday. Data show 330 people are in the hospital with COVID-19 not in intensive care, up from 309 reported on Wednesday and 239 reported the week prior. The last time Minnesota had more than 100 people in the ICU with COVID-19 was late January, and the hospitalization levels are similar to last September, when a deadly surge in the virus was starting.

You can find more information about Minnesotas current ICU usage and capacity here.

More information on cases can be found here.

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Minnesota health officials continue to report new cases of more contagious COVID-19 variants in the state.

While MDH and its partners dont check every sample for evidence its a variant, they have been increasing surveillance and targeting clusters of cases or instances where people have traveled to measure spread of the variants. The B117 variant is believed to be 50 percent more contagious and resulted in a death rate 64 percent higher than other COVID-19 strains.

State Epidemiologist Dr. Ruth Lynfield told reporters Thursday the state has found 943 cases of the COVID-19 variant known as B117, which was first identified in the U.K. This is up from 479 cases last Tuesday.

Lynfield said that in 2,600 COVID-19 positive samples at one testing lab between March 22 and March 27, between 54-66 percent were found to be B117. In roughly 1,800 positive samples between March 16 and 20, about 50-65 percent were found to be caused by B117.

Among the 943 identified cases of B117, Lynfield said 36 people have been hospitalized and four people have died.

The state has identified 214 cases of variant first identified in California, which is also thought to be more contagious. Of those cases, four people have been hospitalized and two have died.

Health officials believe the 15 million ruined Johnson & Johnson vaccine doses at a Baltimore plant wont immediately affect Minnesotas allocation of the vaccine, said Kris Ehresmann, MDHs infectious disease director.

The state has been expecting an increase in J&J doses over the next several weeks. The vaccine is manufactured elsewhere in addition to the Baltimore plant. At this point, it would seem that it will not affect Minnesotas doses but we are waiting for final confirmation from CDC, Ehresmann said.

Lynfield told reporters that people infected with COVID-19 should ask their doctor if theyre a good fit to use monoclonal antibodies as a treatment. The drug, which is given via intravenous infusion, has been shown in studies to reduce hospitalizations among people at high risk of a severe case of COVID-19.

Lynfield said Minnesota has a supply of more than 9,000 doses and can infuse more than 2,000 people each week. It must be administered within 10 days of when symptoms of COVID-19 begin. The earlier the better.

Not all health care providers have antibody treatments, however. Patients or health care providers can get a referral to where they can get antibody treatments through the states Minnesota Resource Allocation Platform. People need to complete a screening questionnaire on the site.

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Current health guidance says that people who are vaccinated should still not attend large gatherings with unvaccinated people, even though theyre at less risk of severe disease.

Ehresmann said that guidance is because health officials did not know if fully vaccinated people could still be carriers of the disease while not developing symptoms, and may spread the disease to others who arent protected by vaccines yet.

New CDC research suggests vaccinated people arent asymptomatic carriers. Ultimately, Ehresmann said she expects guidance to change accordingly. But she said until there is a larger body of data and evidence, the rules around masking and distancing should still be followed as a safety net to protect others.

Some variants of COVID-19 are also thought to better evade immunity given through vaccination.

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Today on MinnPost

MDHs coronavirus website: https://www.health.state.mn.us/diseases/coronavirus/index.html

MDHs phone line for COVID-19 questions, Mon.-Fri. 9 a.m. to 4 p.m: 651-297-1304

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Coronavirus in Minnesota: 12 more deaths; hospitalizations on the rise - MinnPost

Here's the latest COVID-19 case, death and hospitalization data from the state.

ATLANTA We're breaking down the trends and relaying information from across the state of Georgia as it comes in, bringing perspective to the data and context to the trends.

Visit the 11Alive coronavirus page for comprehensive coverage, find out what you need to know about Georgia specifically, learn more about the symptoms, and keep tabs on the cases around the world.

State and federal officials with the Atlanta-based Centers for Disease Control and Prevention (CDC) are continually monitoring the spread of the virus. They are also working hand-in-hand with the World Health Organization to track the spread around the world and to stop it.

Appling 1879 63

Atkinson 767 16

Baldwin 3786 109

Barrow 8401 126

Bartow 10867 201

Ben Hill 1480 58

Berrien 1042 29

Bleckley 791 33

Brantley 899 30

Bulloch 5156 62

Carroll 7241 129

Catoosa 5385 61

Charlton 1044 23

Chatham 19506 394

Chattahoochee 2965 12

Chattooga 2174 60

Cherokee 21619 287

Clarke 12436 128

Clayton 22371 410

Coffee 4199 132

Colquitt 3466 73

Columbia 10764 157

Coweta 8409 181

Crawford 519 16

DeKalb 55219 873

Decatur 2106 54

Dougherty 5391 272

Douglas 11450 169

Effingham 3666 62

Emanuel 1713 51

Fayette 6423 142

Forsyth 17168 167

Franklin 2303 41

Fulton 78562 1193

Gwinnett 83585 1004

Habersham 4588 144

Haralson 1676 34

Henry 18283 272

Houston 9758 185

Jackson 8319 131

Jeff Davis 1275 37

Jefferson 1556 58

Laurens 3641 141

Liberty 3117 59

Lowndes 7582 136

Lumpkin 2718 61

Madison 2680 44

McDuffie 1620 39

McIntosh 668 14

Meriwether 1473 67

Mitchell 1498 73

Montgomery 707 20

Muscogee 13680 370

Newton 7191 207

Non-GA Resident/Unknown State 23707 445

Oglethorpe 1165 27

Paulding 10372 160

Pickens 2448 58

Randolph 463 32

Richmond 19207 389

Rockdale 5778 144

Seminole 731 17

Spalding 3861 147

Stephens 2932 75

Taliaferro 100 3

Tattnall 1824 42

Thomas 3487 112

Treutlen 622 22

Unknown 2462 11

Walton 7811 226

Washington 1599 56

Whitfield 14572 223

Wilkinson 723 27

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These are the latest COVID numbers in Georgia for April 1, 2021 - 11Alive.com WXIA

AUSTIN, Texas A highly contagious SARS-CoV-2 variant was unknowingly spreading for months in the United States by October 2020, according to a new study from researchers with The University of Texas at AustinCOVID-19 Modeling Consortium. Scientists first discovered it in early December in the United Kingdom, where the highly contagious and more lethal variant is thought to have originated. The journalEmerging Infectious Diseases, whichhas published an early-release version of the study, provides evidence that the coronavirus variant B117 (501Y) had spread across the globe undetected for months when scientists discovered it.

By the time we learned about the U.K. variant in December, it was already silently spreading across the globe, said Lauren Ancel Meyers, the director of the COVID-19 Modeling Consortium at The University of Texas at Austin and a professor of integrative biology. We estimate that the B117 variant probably arrived in the U.S. by October of 2020, two months before we knew it existed.

Analyzing data from 15 countries, researchers estimated the chance that travelers from the U.K. introduced the variant into 15 countries between Sept. 22 and Dec. 7, 2020. They found that the virus variant had almost certainly arrived in all 15 countries by mid-November. In the U.S., the variant probably had arrived by mid-October.

This study highlights the importance of laboratory surveillance, Meyers said. Rapid and extensive sequencing of virus samples is critical for early detection and tracking of new variants of concern.

In conjunction with the papers publication, consortium members developed a new tool that decision-makers anywhere in the United States can use in planning for genetic sequencing that helps to detect the presence of variants. To help the U.S. expand national surveillance of variants, the new onlinecalculatorindicates the number of virus samples that must be sequenced in order to detect new variants when they first emerge. For example, if the goal is to detect an emerging variant by the time it is causing 1 out of every 1,000 new COVID-19 infections, approximately 3,000 SARS-CoV-2 positive specimens per week need to be sequenced.

Health officials are looking for better ways to manage the unpredictability of this virus and future variants, said Spencer Woody, a postdoctoral fellow at the UT COVID-19 Modeling Consortium. Our newcalculatordetermines how many positive SARS-CoV-2 specimens must be sequenced to ensure that new threats are identified as soon as they start spreading.

He explained that the calculator has a second feature. It also helps labs figure out how quickly they will detect new variants, given their current sequencing capacity.

We created this tool to support federal, state and local health officials in building credible early warning systems for this and future pandemic threats, Meyers said.

More detailed information on the calculator ishere.

In addition to Meyers, authors of the Emerging Infectious Disease paper are Zhanwei Du, Bingyi Yang, Sheikh Taslim Ali, Tim K. Tsang, Songwei Shan, Peng Wu, Eric H.Y. Lau and Benjamin J. Cowling of the WHO Collaborating Centre for Infectious Disease Epidemiology and Control in Hong Kong and Lin Wang of the University of Cambridge.

The research was funded by Hong Kongs Health and Medical Research Fund, the National Institutes of Health and the Centers for Disease Control and Prevention.

Meyersholds the Denton A. Cooley Centennial Professorship at The University of Texas at Austin.

Link:

Undetected Coronavirus Variant Was in at Least 15 Countries Before its Discovery - UT News - UT News | The University of Texas at Austin

CLEVELAND, Ohio - Fifty-one Ohio counties remain on red alert for concern of coronavirus spread, the state announced Thursday, as the case rate overall in Ohio has been increasing this spring after a sharp decline through most of the winter.

There were 167.1 known new cases per 100,000 people over the last two weeks, up from the rate of 146.9 per 100,000 reported a week ago, and moving away from Gov. Mike DeWines stated goal of 50 before he will lift his health orders that range from mandated masks in public to limited crowds at entertainment venues.

The rate is based on when people noticed symptoms, not when their cases were reported by the state, which could be days or weeks later. And it excludes incarcerated individuals.

We have in fact seen an increase in COVID-19 activity in Ohio that mirrors what we have seen nationally, said Dr. Bruce Vanderhoff, chief medical officer for the Ohio Department of Health, noting that new strains of the virus have accounted for 80% of Ohios new cases. Here in Ohio variant activity continues to rise.

Vanderhoff noted a sharper increase in new cases along the northern border with Michigan, which has encountered one the nations sharpest increases.

What we have to do is stay on defense by wearing a mask, DeWine said. The other thing is the vaccinations.

The state reported close to 3.5 million Ohioans have received at least their first dose, with all doses completed for about 2 million.

This is a race, DeWine said in encouraging people to get vaccinated. We cannot vaccinate fast enough.

But while the case rate statewide has increased, the number of counties on red alert has declined. A week ago 55 counties were listed on red alert in the states coronavirus advisory system. This compared with 66, 76, 80 and 84 red alert counties the previous four weeks.

Among the red counties are Cuyahoga and each of the six adjacent counties in Greater Cleveland.

Level 3 red alert, according to the health department, means there remains a public emergency for increased exposure and spread, and that people should exercise a high degree of caution. The alert system takes into account more than just new case rates, but also trends in hospitalizations, doctor visits and emergency room visits related to COVID-19.

But for the last several weeks the focus has moved away from the alert map and to the Thursday updates for new cases over the previous two weeks. This is because DeWine on March 4 announced he would condition removal of his health orders to the rate dropping to 50 cases per 100,000.

At the time of his announcement, rates were going down sharply. But they have reversed. The last two updates to the rate, reported each Thursday, mark the only week-to-week increases this year.

Ohio was last below 50 per 100,000 in June. The rate was a record high of 845.5 in mid-December.

Ohio's coronavirus case rate per 100,000 residents, excluding incarcerated individuals, as reported by the Ohio Department of Health. The latest report released on Thursday, April 1, was based on data available through Wednesday, March 31.Rich Exner, cleveland.com

Level 2 orange alert (32 counties): Adams, Allen, Ashtabula, Auglaize, Brown, Columbiana, Coshocton, Darke, Fayette, Fulton, Gallia, Guernsey, Harrison, Hocking, Jackson, Knox, Lawrence, Logan, Meigs, Monroe, Morrow, Noble, Paulding, Preble, Putnam, Scioto, Shelby, Tuscarawas, Van Wert, Vinton, Wayne and Williams.

Level 1 yellow alert (5): Carroll, Clinton, Holmes, Mercer and Morgan.

Case rates by county range from 18.2 per 100,000 in Holmes County to 317 per 100,000 in Clark County. Just four counties are below the target rate of 50 per 100,000 - Homes, Mercer (36.4), Morgan (41.4) and Carroll (44.6).

In Greater Cleveland, the case rate is highest in Summit County:

* Cuyahoga: 194.3 per 100,000 this week versus 167, 162 and 190.6 in the updates each of the previous three weeks.

* Geauga: 123.9 versus 106.8, 122.8 and 147.4 the last three weeks.

* Lake: 136.9 versus, 126, 149.5 and 160.8.

* Lorain: 198.8 versus 148.5, 143 and 159.1.

* Medina County: 178 versus 190.8, 206.4 and 189.7.

* Portage County: 211.1 versus 186.5, 164.3 and 155.7.

* Summit County: 267.3 versus 219, 203.7 and 184.3.

Heres a closer look at the advisory system introduced in early July. Alert levels are determined by the number of warning benchmarks met. But once a county reaches red alert, it does not drop unless its rate of new cases also drops below 100 per 100,000 over two weeks.

* 1. New cases - Alert triggered when there are 50 new cases per cases 100,000 residents over the last two weeks.

* 2. Increase in new cases - Alert triggered by an increase in cases for five straight days at any point over the last three weeks. This is based on the date of onset of symptoms, not when the cases are reported.

* 3. Non-congregate living cases - Alert triggered when at least 50% of the new cases in one of the last three weeks have occurred in outside congregate living spaces such as nursing homes and prisons.

* 4. Emergency rooms - Alert triggered when there is an increase in visits for COVID-like symptoms or a diagnosis for five straight days at any point in the last three weeks.

* 5. Doctor visits - Alert triggered when there is an increase in out-patient visits resulting in confirmed cases or suspected diagnosis for COVID-19 for five straight days at any point in the last three weeks.

* 6. Hospitalizations - Alert triggered when there is an increase in new COVID-19 patients for five straight days at any point over the last three weeks. This is based on the county or residence, not the location of the hospital.

* 7. Intensive Care Unit occupancy - Alert triggered when ICU occupancy in a region exceeds 80% of total ICU beds and at least 20% of the beds are being used for coronavirus patients for at least three days in the last week.

Rich Exner, data analysis editor for cleveland.com, writes about numbers on a variety of topics. Follow on Twitter @RichExner. See other data-related stories at cleveland.com/datacentral.

Previous stories

How close is your ZIP code to reaching the goal of 50 coronavirus cases per 100,000, set by Ohio Gov. Mike DeWine?

How do 2021 births and deaths factor into payments under the third stimulus package? - Thats Rich! Q&A

Decline in Ohio nursing home coronavirus cases levels off

See trends, update, including the percent vaccinated by county

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Fewer Ohio counties on red alert for coronavirus, but statewide case rate is increasing, health department re - cleveland.com

The number of people being vaccinated against COVID-19 is increasing every day in the United States. On average, more than 2.8 million people are being vaccinated against the disease every day.

While vaccines are a vital part of the path out of this pandemic, theyre not fail-proof. In rare cases, officials are reporting breakthrough infections.

In these rare cases, people can still develop COVID-19 despite vaccination.

But experts say these rare cases are expected as more people get vaccinated, and they may ultimately help officials stamp out the coronavirus.

A breakthrough case is when someone develops an illness despite already being fully vaccinated.

This isnt a reason to avoid getting vaccinated. Theres no vaccine that can provide 100 percent immunity against any disease.

Experts say these rare breakthrough COVID-19 cases will give experts a way to determine the extent to which COVID-19 vaccines work and what coronavirus variants may be causing these cases despite vaccination.

I dont think we need to be overly concerned as of yet, said Dr. William Schaffner, professor of preventive medicine and infectious diseases at Vanderbilt University in Nashville, Tennessee.

We should know that these vaccines are not perfect, and under ideal circumstances they provide up to 95 percent chance of protection. Not everyone, particularly those that are frail and partly immunocompromised, may not even get 95 percent protection, he said.

Additionally, while a COVID-19 vaccine isnt completely protective against symptoms, experts stress the vaccine is extremely effective at preventing the most serious complications that lead to hospitalization and death.

In clinical trials, people given COVID-19 vaccines were not hospitalized even in rare cases of developing the disease.

Fully vaccinated people have some immunity against COVID-19, particularly against the strain of the coronavirus the vaccine was made for.

And while COVID-19 vaccines have some protection against several of these variants, it doesnt give full immunity particularly in people who may be immunocompromised.

Most people will mount a strong immunologic response. But individuals who are highly immunocompromised may have a more blunted response, and these individuals need to remain careful even if they are vaccinated, said Dr. David Hirschwerk, attending physician in the department of infectious diseases at Northwell Health in Manhasset, New York.

All of this is expected.

People who are immunocompromised dont always mount the strongest response to vaccines.

And even people who arent immunocompromised can still be vulnerable to breakthrough cases.

Experts say researching these breakthrough cases will be key in understanding the real-world effectiveness of COVID-19 vaccines and the likelihood a coronavirus variant may be able to evade vaccine protection.

Scientists can study any trends and predictors of which individuals may be less protected from vaccination, Hirschwerk said.

Researchers will be studying which groups of people get these breakthrough cases, how frequently they occur, where they occur, and the genetic sequencing of breakthrough variants to figure out how to best fight back against COVID-19.

Schaffner pointed out that by studying breakthrough cases, scientists can monitor for troubling signs of rising variants.

By understanding variants we are able to understand how commonly these phenomena are occurring, Schaffner said of breakthrough cases. And if they are preferentially being caused by variants, we may need a booster dose that protects against those strains.

The Centers for Disease Control and Prevention (CDC) is continuing to assess how COVID-19 vaccines are working in real-world conditions.

Experts will also closely watch what happens when vaccinated people develop COVID-19 and what their symptoms are like.

The majority of these will very likely be of people with mild to moderate symptoms, Hirschwerk told Healthline.

Breakthrough infections are an expected outcome in any vaccination process. No vaccines is 100 percent fail-proof.

These breakthrough cases arent a reason to panic. Instead, experts say they show why we still need to practice mask wearing, handwashing, and physical distancing measures while scientists learn how and why these cases are occurring.

And most importantly, these breakthrough cases shouldnt deter the public from getting vaccines, as they do work.

COVID-19 vaccines remain extremely effective in preventing severe and life threatening cases of COVID-19.

Rajiv Bahl, MD, MBA, MS, is an emergency medicine physician and health writer. You can find him at http://www.RajivBahlMD.com.

Originally posted here:

Rare 'Breakthrough' Cases of COVID-19 Occurring in Vaccinated People - Healthline

KINGSTON, N.Y. Ulster County reported Thursday a steep decline in active COVID-19 cases while saying its most recent positivity rate soared past 8%.

Ulster also said Thursday that there were two more COVID-19 related deaths, bringing that total to 245 since the pandemic began in March 2020.

Editors note: In the interest of public safety, critical coronavirus coverage is being provided free to all readers. Support reporting like thiswith a subscription to the Freeman.

According to its online dashboard, Ulster reported 1,788 active cases of COVID-19, down 90 from 1,878 cases reported on Tuesday.

The Ulster total is still higher than its recent low of 1,488, reached on March 1, but also below its peak of 2,622, set on Jan. 30.

Ulster County reported Thursday that 98 of its residents were diagnosed with COVID-19 among the most recent 1,197 to be tested, a positivity rate of 8.2%.

Ulster reported on Thursday it has had 13,179 confirmed cases of COVID-19 and 11,146 recoveries since March 2020.

According to the state COVID-19 vaccine tracker, 35.5% of Ulster residents have received at least one dose of the vaccine. The tracker says that 32,311 have completed with vaccination series and 63,331 have gotten at least one shot.

Dr.Neal Smoller, owner of Village Apothecary in Woodstock , NY gives out vaccinations at Best Buy in Town Of Ulster, New York.

Dutchess County said Thursday that its active COVID-19 cases saw the largest decrease this week from 1,405 reported on Wednesday to 1,361, down by 44.

Dutchess has been experiencing a weekslong rise in its number of active COVID-19 cases. The number peaked at 2,576 on Jan. 16 and then fell to 713 by Feb. 15 before starting a steady increase.

Meanwhile, Dutchess also reported Thursday that there were no additional deaths, with the total remaining at 425 since the pandemic began in March 2020.

The county also reported Thursday that 62 residents were hospitalized with COVID-19, up by three reported the day before.

Dutchess has had 26,044 confirmed cases of COVID-19 since the local outbreak began. Its latest seven-day average of positive test results is 4.34%.

The vaccine tracker says 31.9% of Dutchess County residents have received at least one dose of the COVID-19 vaccine. It says that 48,928 people have completed the vaccination process while93,658 people have got at least one dose.

Nursing Homes

The state reported Thursday a COVID-19 related death of a resident at the Golden Hill Nursing and Rehabilitation Center in Kingston. The resident died outside the nursing home, the state said.

There have been 21 COVID-related deaths of residents at the Golden Hill facility since the beginning of the pandemic and 10 facility residents have died elsewhere, according to state numbers.

In all, Ulster County has had 88 nursing home residents die in facilities and 34 who have lost their lives from the disease elsewhere.

For local coverage related to the coronavirus, go to bit.ly/DFCOVID19. To check vaccination eligibility in Ulster County and sign up, go to vaccinateulster.com.

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Coronavirus: Ulster active cases drop but county reports two more deaths and rise in rate of new cases - The Daily Freeman