Category Archives: Covid-19

By the numbers

Q3 revenue: $4.64B

0.7% year-over-year increase on a reported basis

Base revenue: $4.57B

6% year-over-year increase

COVID-19 testing revenue: $76M

75% year-over-year decrease

Q3 trends: Becton Dickinsons third quarter revenue was relatively flat compared to 2021 as growth in its base business was offset by a 75% year-over-year drop in COVID-19 testing sales. CEO Tom Polen said on a Thursday earnings call that the company was affected by many of the same challenges the industry is managing inflation, supply chain constraints, healthcare staff shortages and rising labor costs, China slowdown but its base business was still able to grow over last years quarter.

Stifel analysts wrote in a Thursday note that BDs $4.64 billion in revenue last quarter beat the investment firms estimate by about $170 million driven in part by incremental Covid testing sales, but also strong all-around performance from nearly every other business line.

COVID-19 testing: While coronavirus testing revenue declined year over year by about $224 million last quarter, sales still beat analyst expectations, according to J.P. Morgan. The analysts wrote in a Thursday note that BDs $76 million of sales came in ahead by about $44 million. The company expects stronger COVID-19 sales for the full year, increasing its forecast by about $50 million to a total of $500 million.

Still, the testing demand slowdown is expected to continue for the remainder of its fiscal year and into 2023. CFO Christopher DelOrefice said that the COVID-19 testing revenue will drop to $25 million next quarter, and the business in BDs fiscal year 2023 will be significantly below 2022. DelOrefice said that approximately $25 million in quarterly sales is likely to be where future quarters fall. So far this year, COVID-19 testing revenue totals about $475 million.

2022 revenue forecast: BD increased its full-year revenue forecast to a range of $18.75 billion to $18.83 billion compared to $18.5 billion to $18.7 billion previously announced. The base business forecast was increased by $215 million at the midpoint.

The companys stock price was up over 2% to $250.15 Thursday morning.

China recovery: Polen told investors that a slowdown in China due to restrictions put in place to stop the spread of the coronavirus continued into BDs third quarter, but the market rebounded faster than expected, with a strong recovery in June. Beyond the recovery of hospital patient flow, we initiated several actions to continue manufacturing and keep warehousing largely operational by working closely with our stakeholders in China, Polen said.

2023 trends: DelOrefice said that macroeconomic challenges are expected to continue in its fiscal year 2023, which typically begins in October. But the CFO added that the economic challenges are not expected to get worse next year and some may improve in the second half, such as the current complexity and challenges with the supply chain.

Read more:

BD's base business growth in Q3 offset by drop in COVID-19 testing - MedTech Dive

Pregnancy is a really exciting time, to be sure. But lets be real: It can also be stressful especially during this era of COVID-19.

Pregnant people are one of several groups at a higher risk of becoming very ill from COVID-19. COVID-19 can also lead to serious pregnancy complications as well.

The good news is that the COVID-19 vaccine can protect against severe illness and complications. The Centers for Disease Control and Prevention (CDC) recommends that anyone who is pregnant, breastfeeding, or plans to become pregnant get a COVID-19 vaccine and booster.

Getting vaccinated during pregnancy may feel intimidating, but were here to help. Keep reading as we go over eight facts about the COVID-19 vaccine that are backed by research.

According to the CDC, if youre pregnant, you have a higher risk of serious illness from COVID-19. This can include things like:

Thats not all, though: COVID-19 can also have serious consequences for your pregnancy. Thats because if you get COVID-19 while pregnant, you have a higher risk of pregnancy complications.

A March 2022 review of research notes that various studies have found that getting COVID-19 while pregnant is associated with an increased risk of:

Vaccination can go a long way in helping prevent these complications.

Lets get a big concern out of the way next: COVID-19 vaccines are indeed safe and effective during pregnancy.

Since the COVID-19 vaccines have been available, many studies have supported this. Were not going to cover each one of them here (that would take all day), but lets explore what some of them say.

Researchers in a 2021 study looked at the effectiveness of the Pfizer-BioNTech COVID-19 vaccine in pregnant women. They compared 7,530 vaccinated pregnant women and 7,530 unvaccinated pregnant women.

Overall, researchers found vaccinated women had a significantly lower risk of contracting the coronavirus that causes COVID-19 than their unvaccinated counterparts.

Further, none of the vaccinated women reported serious side effects from vaccination. The most common side effects were similar to those seen in the general population and included:

Vaccines work by introducing your immune system to a germ. Your immune system crafts a response, which includes antibodies, to the vaccine. Your immune system can then call upon this response to protect you from the actual germ in the future.

Another bit of good news is that pregnant people appear to make the same immune response to COVID-19 vaccination as nonpregnant people.

In a 2021 study, researchers compared immune responses in 131 pregnant, lactating, or nonpregnant women. They found the levels of antibodies made in response to vaccination were similar between all three groups. Side effects were also similar in all groups.

And theres more: Antibody levels made in response to vaccination during pregnancy were higher than the antibodies made from infection during pregnancy.

Despite the safety and effectiveness of the COVID-19 vaccine during pregnancy, vaccination in this group is still low compared with the general population.

For example, a January 2022 study in Scotland found that in October 2021, only 32.3% of women giving birth had received two doses of a COVID-19 vaccine, compared with 77.4% of the total female population.

A 2021 study found that out of a group of 1,328 pregnant women, less than one-third got the COVID-19 vaccine when it was offered to them. Vaccinated women still had similar pregnancy outcomes to those who were not vaccinated.

Raising vaccine coverage is vital for preventing severe illness and complications during pregnancy. However, concerns about the vaccine and its potential effects have made people hesitant. Lets explore some of these concerns next.

One concern about the COVID-19 vaccine is whether it increases the risk of miscarriage. Research says this isnt the case.

A 2021 research letter outlines a study on this topic. For the study, researchers used the Vaccine Safety Datalink database to analyze COVID-19 vaccines and miscarriage rates. Data from about 3% of the U.S. population is included in this database.

Researchers found 105,446 unique pregnancies, 92,286 of which were ongoing and 13,160 of which resulted in miscarriage. All three COVID-19 vaccines used in the United States were represented within this large group.

Researchers wanted to see whether COVID-19 vaccines were linked with miscarriage. They were specifically looking to see whether people who had a miscarriage were more likely to have received a COVID-19 vaccine in the past 28 days.

This isnt what they found. Instead, researchers saw that, compared with those with ongoing pregnancies, women who had a miscarriage were not more likely to have received a COVID-19 vaccine in the previous 28 days.

COVID-19 vaccination is also not associated with birth and delivery complications.

Researchers in a March 2022 study reviewed data from a population-based survey. Among a group of 97,590 pregnant people, 22,660 (23%) had gotten at least one dose of a COVID-19 vaccine during their pregnancy.

Researchers compared people who were vaccinated during their pregnancy to those who got vaccinated after their pregnancy. They found that vaccination during pregnancy did not lead to a significantly increased risk of:

Another large March 2022 study also supports these findings. This study used data from 157,521 deliveries of single babies (no twins, triplets, etc.) in Sweden and Norway.

Within this group, 28,506 pregnancies (18%) included COVID-19 vaccination at some point during pregnancy. Compared with pregnancies in which no COVID-19 vaccine was given, researchers found that among the pregnancies with vaccination, there was no increased risk of:

If youre not yet pregnant but plan to be in the near future, you may wonder whether the COVID-19 vaccine could affect your fertility. According to the CDC, theres currently no evidence that COVID-19 vaccines cause fertility issues.

Research supports this statement. A January 2022 study included 2,126 self-identified female participants ages 21 through 45 who were trying to get pregnant. Participants completed surveys every 8 weeks about:

After analyzing the data, researchers concluded that COVID-19 vaccination was not associated with long-term decreased fertility in either females or males.

But researchers did find that getting COVID-19 itself was associated with a potential temporary decline in male fertility for about 60 days.

Now that weve debunked the main concerns about COVID-19 vaccination during pregnancy, lets take a look at some of the benefits that vaccination may give your baby.

Antibodies that your body makes after vaccination can be passed to your baby through the placenta. These antibodies can go on to protect them when theyre particularly vulnerable to germs in the months after birth.

A June 2022 study included 21,643 babies, 9,739 (45%) of whom were born to mothers who had gotten their second or third dose of a COVID-19 vaccine during pregnancy.

Researchers found these babies had a lower risk of having a positive COVID-19 test within 4 months of birth. This finding persisted during both the Delta and Omicron coronavirus variant waves, although protection was stronger against Delta.

A February 2022 study included 379 hospitalized babies; 176 of them had COVID-19 and the other 203 babies were hospitalized for other reasons.

Researchers wanted to see how effective maternal vaccination was at preventing COVID-19 hospitalization of a baby within their first 6 months of life. Using this parameter, researchers found that vaccine effectiveness was:

How long does this protection last, though? Researchers aimed to find this out.

According to a February 2022 research letter, experts compared antibody levels in babies whose mothers had either been vaccinated against COVID-19 during pregnancy or who had actually had COVID-19 during pregnancy.

Overall, researchers found that antibody levels in babies whose mothers had been vaccinated against COVID-19 while pregnant stuck around for longer.

Six months after birth, 57% of babies born to vaccinated mothers still had detectable antibodies. Only 8% of babies whose mothers had COVID-19 during pregnancy had detectable antibodies.

Its known that breastfeeding parents pass antibodies to their babies through breast milk. These antibodies can help protect a baby from various germs.

Antibodies made in response to COVID-19 vaccination have been detected in breast milk. Lets look at a research letter about a 2021 study that discussed this.

The study included 84 breastfeeding mothers who provided 504 breast milk samples over the course of the study. After getting the first dose of the Pfizer-BioNTech vaccine, participants were followed up weekly for 6 weeks.

Researchers looked for two types of antibodies to COVID-19 called IgA and IgG. IgA is found earlier in the immune response. IgG appears later.

They found the amount of breast milk samples with IgA rose early after vaccination. They peaked at week 4 (1 week after the second dose) before beginning to drop at week 6.

Few breast milk samples contained IgG after the first vaccine dose. However, by weeks 4 and 6, more than 90% of breast milk samples had detectable IgG.

This all sounds great, right? There are some caveats: The number of participants was small, and its unknown how long these antibodies last or the strength of protection they provide to a baby. More research will help find these things out, though.

The COVID-19 vaccine is safe and effective during pregnancy. Its vital for preventing serious illness and pregnancy complications from COVID-19.

The COVID-19 vaccine has not been associated with an increased risk of infertility, miscarriage, or other pregnancy and delivery complications.

In fact, vaccinated pregnant people can pass antibodies to their baby both through the placenta and breast milk. These antibodies can continue to protect babies after theyre born.

The COVID-19 vaccine is recommended for all people who are pregnant, breastfeeding, or plan to get pregnant. If you ever have questions or concerns about getting the COVID-19 vaccine, be sure to raise them with your doctor or another healthcare professional.

Read more:

8 Facts You Need to Know About the COVID-19 Vaccine & Pregnancy - Healthline

Governor Mills proposed and the Legislature approved the payments as part of bipartisan budget to help facilities recover from the pandemic

Governor Janet Mills announced today that her Administration has issued $25 million in one-time COVID-19 payments to 211 long-term care organizations to help them recover from the COVID-19 pandemic. Governor Mills proposed the MaineCare (Medicaid) payments in her supplemental budget that was passed by the Legislature on a bipartisan basis. Additionally, the Maine Department of Health and Human Services (DHHS) is increasing flexibility in the use of these and related funds, such as for fuel and other costs related to global inflation.

Long-term care facilities provide critical services for Maine people, and they are still feeling the impacts of the pandemic challenges that have only been made more difficult by inflation, said Governor Janet Mills. I am proud the Legislature supported my proposal to provide additional funding, and I am pleased we are getting these resources into the hands of our caregivers quickly so they can continue to do their important work it could not come at a better time.

This injection of funding will help long-term care facilities offset unexpectedly high costs such as contract staff, food, and other pandemic-related expenses,said Jeanne Lambrew, Commissioner of the Department of Health and Human Services. The grants are part of unprecedented support for these facilities that not only recognizes their critical role during the COVID-19 pandemic but reflects Governor Mills commitment to making high-quality long-term services and supports affordable and accessible for Maine residents.

Today's announcement is welcome news as Maine's long-term care facilities and their dedicated caregivers continue to feel the impact of COVID-19, said Angela Westhoff, President and CEO of the Maine Health Care Association.Weappreciate Governor Mills' recognition of the persistent strain on providers and are thankful that additional resources are being distributed. We are also pleased with the Administrations response to our request for greater flexibility in the use of these funds with respect to labor costs, as our members persevere toprovide care tothousands of vulnerable Maine citizens each day.

The 211 organizations receiving grants represent 272 service locations throughout the state. The $25 million will be distributed proportionally based on each facilitys 2019 MaineCare revenue and total MaineCare bed days in 2021. For facilities that received little to no MaineCare revenue in 2019, the Department will use revenue from a more recent 12-month period to determine distribution of the supplemental payment amounts by facility.

The Department is also informing long-term care facilities about greater flexibility on the uses of one-time funding to help them recover from the pandemic and combat rising costs associated with inflation. This includes addressing pandemic-related cost increases of hiring and retaining staff and higher expenses, such as for food, fuel, and energy bills. This flexibility applies to the new $25 million announced today as well as to any remaining funds from last years $123 million one-time COVID-19 supplemental payments to nursing facilities, residential care facilities, and adult family care homes.

These payments build on the Mills Administrations historic financial and operational support for nursing facilities, which includes:

This is in addition to at least $50 million in financial relief distributed directly by the Federal government to nursing facilities across Maine.

Pandemic Support: Since the beginning of the pandemic, nursing facilities have submitted and received over 330,000 COVID-19 test results from Maines Health and Environmental Testing Laboratory and these facilities have also placed over 6,400 personal protective equipment (PPE) requests and received over 2.1 million pieces of PPE. Since January 2021, the Department has used over $2 million in Federal funds to support 23,910 hours of emergency nurse and related staffing to nearly one-third of Maine long-term care facilities to support care for residents during the pandemic.

Workforce Training: Recognizing the need to address the workforce challenges exacerbated by the COVID-19 pandemic, Governor Mills included $20 million in theMaine Jobs and Recovery Planto support health care workforce training. This includes scholarships and student loan relief to enable more people to become behavioral health specialists, long term support workers, emergency medical services staff, and other health professionals. The Jobs Plan additionally supports marketing campaigns aimed at promoting health care careers in Maine andHealthcare Training for ME, a program to expand the availability of free and low-cost career training to help health care workers advance their careers, support workforce training needs of health care employers, and attract new workers to fast-growing fields. The Jobs Plan is also supporting the Caring for ME campaign to educate and encourage residents to become direct care providers.

Cabinet on Aging: Governor Mills established the Cabinet on Aging on June 13, 2022 to help Maine prepare for and address demographic changes by advancing policies that will support Maine people in aging safely, affordably, and in ways and settings that best serve their needs. The Cabinet will bring together State government agencies to improve coordination and to accelerate action. It held its first meeting on July 28 and is likely to consider reforms to long-term services and supports in Maine.

See the rest here:

Mills Administration Issues $25 Million in COVID-19 Payments to Support 211 Long-Term Care Organizations | Office of Governor Janet T. Mills -...

People with HIV remain at higher risk of dying after being admitted to hospital with COVID-19 and have not experienced the same decline in COVID-related mortality as HIV-negative people during the Omicron wave of the pandemic, a research team from the World Health Organization (WHO) reported this week at the 24th International AIDS Conference (AIDS 2022).

At last years IAS Conference on HIV Science, the same team presented results of a global analysis of data submitted to the WHO Global Clinical Platform on COVID-19, showing that people with HIV were more likely to be admitted to hospital with COVID-19 and 30% more likely to die after admission for COVID-19.

The updated study presented this week analysed further data submitted to the clinical platform from 50 countries on people hospitalised with COVID-19 from the beginning of the pandemic to May 2022. Data on HIV status of hospitalised patients was available for 42 countries, covering 362,841 people. Just over 8% (29,530) were living with HIV. Ninety-six per cent of the data on people with HIV came from Africa, predominantly from South Africa. This study was not able to collect data on vaccination status or previous COVID-19 illness, so it is not possible to say what effect they had on outcomes.

The presence of one or more additional health conditions at the same time as a primary condition (such as HIV).

A group of diseases characterized by high levels of blood sugar (glucose). Type 1 diabetes occurs when the body fails to produce insulin, which is a hormone that regulates blood sugar. Type 2 diabetes occurs when the body either does not produce enough insulin or does not use insulin normally (insulin resistance). Common symptoms of diabetes include frequent urination, unusual thirst and extreme hunger. Some antiretroviral drugs may increase the risk of type 2 diabetes.

A drug that acts against a virus or viruses.

When blood pressure (the force of blood pushing against the arteries) is consistently too high. Raises the risk of heart disease, stroke, kidney failure, cognitive impairment, sight problems and erectile dysfunction.

Several symptoms were more common in people with HIV compared to HIV-negative people. In order of frequency, fever (66%), shortness of breath (59%), fatigue (41%), headache (31%), chest pains (27%), loss of smell (25%) and muscle ache (19%) were more common in people with HIV than HIV-negative people. However, cough was somewhat less frequent in people with HIV (47%) than in HIV-negative people (53%).

Underlying health conditions were more common in people with HIV than HIV-negative people. Fifty-nine per cent of people with HIV who were hospitalised had at least one underlying health condition compared to 45% of HIV-negative people (p<0.001), most commonly hypertension (30%), obesity (29%), tuberculosis (27%) and diabetes (19%). With the exception of tuberculosis, which was much less common in HIV-negative people (2%), the prevalence of underlying conditions was similar in HIV-negative people. Seven per cent of people with HIV had at least three underlying health conditions.

In the updated analysis, people with HIV had a 51% increased risk of dying after admission to hospital with COVID-19, a slightly higher rate than reported previously.

Analysis by CD4 count (above or below 200) and viral load (above or below 1000) showed that having a CD4 count below 200 and a viral load above 1000 doubled the risk of dying after admission to hospital after adjusting for age, gender and co-morbidities (adjusted hazard ratio 1.96, 95% CI 1.81-2.12) when compared to HIV-negative people. People with HIV with CD4 counts below 200 and suppressed viral load (<1000 copies/ml) had a 62% higher risk (aHR 1.62, 95% CI 1.52-1.73) of dying.

A CD4 count above 200 and an unsuppressed viral load was associated with a 29% increase in the risk of dying while a CD4 count above 200 and a suppressed viral load was associated with a 12% increased risk of dying.

"The study findings emphasise the importance of promoting vaccination to people with HIV."

The WHO researchers also looked at changes in death rates over time. In 2020, during the Alpha and Beta variant waves of the pandemic, 24% of people with HIV and 21% of HIV-negative people died after hospitalisation with COVID-19. Death rates were similar in 2021 too, when Alpha, Beta and Delta variants predominated (24% and 22%, respectively). But in 2022, as the Omicron variant replaced previous variants, death rates diverged. Whereas the death rate after hospitalisation fell to 8% in the year to date in HIV-negative people, the death rate remains close to 20% in people with HIV (19.8%).

When they compared death rates between the Delta wave (August to October 2021) and the Omicron wave (November 2021 to May 2022) in South Africa, the researchers found that whereas people with HIV were 55% more likely to die during the Delta wave (aHR 1.55), they were more than twice as likely to die during the Omicron wave (aHR 2.47).

Dr Silvia Bertagnolio of WHO said that the continuing high death rate in people with HIV is also likely to reflect low vaccination coverage in the country contributing most of the data. By the end of 2021, 27% of South Africans had been vaccinated against COVID-19 and coverage is now estimated to have reached 32%. Bertagnolio said that vaccine coverage is still unacceptably low in sub-Saharan Africa, where 18% of the population have been vaccinated compared to a global average of 62%.

She said the study findings emphasise the importance of improving access to vaccination, promoting vaccination to people with HIV and making COVID-19 antiviral medication available for people with HIV to reduce the risk of severe outcomes.

She also stressed the importance of minimising exposure to COVID-19 among people with HIV, especially people with CD4 counts below 200 or co-morbidities, as well as ensuring uninterrupted antiretroviral treatment.

Preliminary results from the Ubuntu study of mRNA SARS-CoV-2 vaccination in South Africa, presented as a late breaker on the final day of AIDS 2022, reinforced the importance of minimising SARS-CoV-2 exposure in people with HIV.

Baseline screening results of the study, in which participants were tested for the virus before vaccination, showed that 31% of study participants screened during November and December 2021 at the beginning of the Omicron variant wave had positive SARS-CoV-2 PCR tests.

Between November 2021 and July 2022, 8% of people with HIV with no prior SARS-CoV-2 had asymptomatic SARS-CoV-2 at baseline. The risk of asymptomatic infection was higher in people without a prior history of SARS-CoV-2.

People with HIV with lower CD4 counts were at higher risk of being diagnosed with SARS-CoV-2 at baseline after adjusting for prior exposure, sex assigned at birth and temporal trend. Every tenfold reduction in CD4 count was associated with a doubling in the risk of a positive result. A person with a CD4 count of 50 had an approximately 50% probability of testing positive at baseline screening in December 2021 compared to a 25% probability in people with CD4 counts around 500.

References

Bertagnolio S et al. Are people living with HIV at higher risk of severe and fatal COVID-19? 24th International AIDs Conference, Montreal, abstract OAB0404, 2022.

View the abstract on the conference website.

Tapley A et al. High prevalence of asymptomatic Omicron carriage and correlation with CD4+ T cell count among adults with HIV enrolling in COVPN 3008 Ubuntu clinical trial in sub-Saharan Africa. 24th International AIDs Conference, Montreal, abstract OALBC0102, 2022.

View the abstract on the conference website.

See the article here:

People with HIV still at higher risk of death from COVID-19 in Omicron wave - aidsmap

Stacker compiled a list of the counties with highest COVID-19 infection rates in Rhode Island using data from the U.S. Department of Health & Human Services and vaccination data from Covid Act Now. Counties are ranked by the highest infection rate per 100,000 residents within the week leading up to August 2, 2022. Cumulative cases per 100,000 served as a tiebreaker.

Keep reading to see whether your county ranks among the highest COVID-19 infection rates in your state.

New cases per 100k in the past week: 140 (115 new cases, +19% change from previous week) Cumulative cases per 100k: 28,300 (23,229 total cases) 23.3% less cases per 100k residents than Rhode Island Cumulative deaths per 100k: 117 (96 total deaths) 65.9% less deaths per 100k residents than Rhode Island Population that is fully vaccinated: 76.2% (62,552 fully vaccinated)

New cases per 100k in the past week: 147 (185 new cases, -4% change from previous week) Cumulative cases per 100k: 29,818 (37,445 total cases) 19.2% less cases per 100k residents than Rhode Island Cumulative deaths per 100k: 193 (242 total deaths) 43.7% less deaths per 100k residents than Rhode Island Population that is fully vaccinated: 80.0% (100,413 fully vaccinated)

New cases per 100k in the past week: 153 (74 new cases, -16% change from previous week) Cumulative cases per 100k: 32,348 (15,682 total cases) 12.4% less cases per 100k residents than Rhode Island Cumulative deaths per 100k: 369 (179 total deaths) 7.6% more deaths per 100k residents than Rhode Island Population that is fully vaccinated: 79.9% (38,755 fully vaccinated)

New cases per 100k in the past week: 166 (1,059 new cases, -4% change from previous week) Cumulative cases per 100k: 38,429 (245,536 total cases) 4.1% more cases per 100k residents than Rhode Island Cumulative deaths per 100k: 405 (2,586 total deaths) 18.1% more deaths per 100k residents than Rhode Island Population that is fully vaccinated: 71.7% (458,022 fully vaccinated)

New cases per 100k in the past week: 194 (319 new cases, +4% change from previous week) Cumulative cases per 100k: 33,936 (55,754 total cases) 8.1% less cases per 100k residents than Rhode Island Cumulative deaths per 100k: 317 (520 total deaths) 7.6% less deaths per 100k residents than Rhode Island Population that is fully vaccinated: 79.5% (130,530 fully vaccinated)

See more here:

Counties with highest COVID-19 infection rates in Rhode Island - What'sUpNewp

Yale University, New Haven, CT, USA

Gita A. Pathak&Renato Polimanti

Institute for Molecular Medicine Finland (FIMM), Univerisity of Helsinki, Helsinki, Finland

Juha Karjalainen,Mark Daly,Andrea Ganna&Mark J. Daly

Broad Institute of MIT and Harvard, Cambridge, MA, USA

Christine Stevens,Mark Daly,Andrea Ganna,Masahiro Kanai,Rachel G. Liao,Amy Trankiem,Mary K. Balaconis,Huy Nguyen,Matthew Solomonson,Kumar Veerapen,Samuli Ripatti,Lindo Nkambul,Mark J. Daly,Sam Bryant&Vijay G. Sankaran

Massachusetts General Hospital, Broad Institute of MIT and Harvard, Cambridge, MA, USA

Benjamin M. Neale

Analytic and Translational Genetics Unit, Massachusetts General Hospital, Boston, MA, USA

Mark Daly,Andrea Ganna,Konrad J. Karczewski,Alicia R. Martin,Elizabeth G. Atkinson,Masahiro Kanai,Kristin Tsuo,Nikolas Baya,Patrick Turley,Rahul Gupta,Raymond K. Walters,Duncan S. Palmer,Gopal Sarma,Matthew Solomonson,Nathan Cheng,Wenhan Lu,Claire Churchhouse,Jacqueline I. Goldstein,Daniel King,Wei Zhou,Cotton Seed,Mark J. Daly,Benjamin M. Neale,Hilary Finucane,F. Kyle Satterstrom&Sam Bryant

Icahn School of Medicine at Mount Sinai, New York, NY, USA

Shea J. Andrews,Laura G. Sloofman,Stuart C. Sealfon,Clive Hoggart&Slayton J. Underwood

Institute for Molecular Medicine Finland (FIMM), University of Helsinki, Helsinki, Finland

Mattia Cordioli,Matti Pirinen,Kati Donner,Katja Kivinen,Aarno Palotie&Mari Kaunisto

Icahn School of Medicine at Mount Sinai, Genetics and Genomic Sciences, York City, NY, USA

Nadia Harerimana

Centre for Bioinformatics and Data Analysis, Medical University of Bialystok, Bialystok, Poland

Karolina Chwialkowska

University of Michigan, Ann Arbor, MI, USA

Brooke Wolford

Ancestry, Lehi, UT, USA

Genevieve Roberts,Danny Park,Catherine A. Ball,Marie Coignet,Shannon McCurdy,Spencer Knight,Raghavendran Partha,Brooke Rhead,Miao Zhang,Nathan Berkowitz,Michael Gaddis,Keith Noto,Luong Ruiz,Milos Pavlovic,Eurie L. Hong,Kristin Rand,Ahna Girshick,Harendra Guturu&Asher Haug Baltzell

Institute for Molecular Medicine Finland (FIMM), Helsinki, Finland

Mari E. K. Niemi&Sara Pigazzini

University of Liege, GIGA-Institute, Lige, Belgium

Souad Rahmouni,Michel Georges&Yasmine Belhaj

CHC Mont-Lgia, Lige, Belgium

Julien Guntz&Sabine Claassen

5BHUL (Lige Biobank), CHU of Lige, Lige, Belgium

Yves Beguin&Stphanie Gofflot

Institute for Molecular Medicine Finland, University of Helsinki, Helsinki, Finland

Mattia Cordioli

Analytic & Translational Genetics Unit, Massachusetts General Hospital, Boston, MA, USA

Lindokuhle Nkambule,Lindokuhle Nkambul,Lindokuhle Nkambule&Lindo Nkambul

Stanley Center for Psychiatric Research, Broad Institute of MIT and Harvard, Cambridge, MA, USA

Lindokuhle Nkambule

Program in Medical and Population Genetics, Broad Institute of MIT and Harvard, Cambridge, MA, USA

Lindokuhle Nkambule,Konrad J. Karczewski,Alicia R. Martin,Elizabeth G. Atkinson,Masahiro Kanai,Kristin Tsuo,Nikolas Baya,Patrick Turley,Rahul Gupta,Raymond K. Walters,Duncan S. Palmer,Gopal Sarma,Matthew Solomonson,Nathan Cheng,Wenhan Lu,Claire Churchhouse,Jacqueline I. Goldstein,Daniel King,Wei Zhou,Cotton Seed,Benjamin M. Neale,Hilary Finucane,F. Kyle Satterstrom,Sam Bryant&Caroline Cusick

CHU of Liege, Lige, Belgium

Michel Moutschen,Benoit Misset,Gilles Darcis,Julien Guiot,Samira Azarzar,Olivier Malaise,Pascale Huynen,Christelle Meuris,Marie Thys,Jessica Jacques,Philippe Lonard,Frederic Frippiat,Jean-Baptiste Giot,Anne-Sophie Sauvage,Christian Von Frenckell&Bernard Lambermont

University of Liege, Lige, Belgium

Michel Moutschen,Benoit Misset,Gilles Darcis,Julien Guiot&Samira Azarzar

Department of Human Genetics, McGill University, Montreal, Quebec, Canada

Tomoko Nakanishi

Lady Davis Institute, Jewish General Hospital, McGill University, Montreal, Quebec, Canada

Tomoko Nakanishi,David R. Morrison,J. Brent Richards,Guillaume Butler-Laporte,Vincenzo Forgetta,Biswarup Ghosh,Laetitia Laurent,Danielle Henry,Tala Abdullah,Olumide Adeleye,Noor Mamlouk,Nofar Kimchi,Zaman Afrasiabi,Nardin Rezk,Branka Vulesevic,Meriem Bouab,Charlotte Guzman,Louis Petitjean,Chris Tselios,Xiaoqing Xue,Jonathan Afilalo&Darin Adra

Kyoto-McGill International Collaborative School in Genomic Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan

Tomoko Nakanishi

Research Fellow, Japan Society for the Promotion of Science, Tokyo, Japan

Tomoko Nakanishi

McGill Genome Centre and Department of Human Genetics, McGill University, Montreal, Quebec, Canada

Vincent Mooser,Rui Li,Alexandre Belisle,Pierre Lepage,Jiannis Ragoussis,Daniel Auld&G. Mark Lathrop

Department of Human Genetics, Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada

J. Brent Richards

Department of Twin Research, Kings College London, London, UK

J. Brent Richards

Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montral, Qubec, Canada

Guillaume Butler-Laporte

Department of Emergency Medicine, McGill University, Montreal, Quebec, Canada

Marc Afilalo

Emergency Department, Jewish General Hospital, McGill University, Montreal, Quebec, Canada

Marc Afilalo

McGill AIDS Centre, Department of Microbiology and Immunology, Lady Davis Institute for Medical Research, Jewish General Hospital, McGill University, Montreal, Quebec, Canada

Maureen Oliveira

McGill Centre for Viral Diseases, Lady Davis Institute, Department of Infectious Disease, Jewish General Hospital, Montreal, Quebec, Canada

Bluma Brenner

Research Centre of the Centre Hospitalier de lUniversit de Montral, Montreal, Canada

Nathalie Brassard

Department of Medicine, Research Centre of the Centre Hospitalier de lUniversit de Montral, Montreal, Canada

Madeleine Durand

Department of Medicine, Universit de Montral, Montreal, Canada

Madeleine Durand,Michal Chass&Daniel E. Kaufmann

Department of Medicine and Human Genetics, McGill University, Montreal, Quebec, Canada

Erwin Schurr

Department of Intensive Care, Research Centre of the Centre Hospitalier de lUniversit de Montral, Montreal, Quebec, Canada

Michal Chass

Division of Infectious Diseases, Research Centre of the Centre Hospitalier de lUniversit de Montral, Montreal, Quebec, Canada

Daniel E. Kaufmann

MRC Human Genetics Unit, Institute of Genetics and Cancer, University of Edinburgh, Western General Hospital, Edinburgh, UK

Caroline Hayward,Anne Richmond&J. Kenneth Baillie

Center for Applied Genomics, Childrens Hospital of Philadelphia, Philadelphia, PA, USA

Joseph T. Glessner,Hakon Hakonarson&Xiao Chang

Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA

Joseph T. Glessner&Hakon Hakonarson

Vanderbilt University Medical Center, Nashville, TN, USA

Douglas M. Shaw,Jennifer Below,Hannah Polikowski,Petty E. Lauren,Hung-Hsin Chen,Zhu Wanying,Lea Davis&V. Eric Kerchberger

Centre for Genomic and Experimental Medicine, Institute of Genetics and Cancer, University of Edinburgh, Western General Hospital, Edinburgh, UK

Archie Campbell,David J. Porteous&Chloe Fawns-Ritchie

Usher Institute, University of Edinburgh, Nine, Edinburgh Bioquarter, Edinburgh, UK

Archie Campbell

University of Texas Health, Houston, TX, USA

Marcela Morris&Joseph B. McCormick

Department of Psychology, University of Edinburgh, Edinburgh, UK

Chloe Fawns-Ritchie&Chloe Fawns-Ritchie

University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

Kari North

Center for Applied Genomics, The Childrens Hospital of Philadelphia, Philadelphia, PA, USA

Xiao Chang,Joseph R. Glessner&Hakon Hakonarson

Division of Human Genetics, Department of Pediatrics, The Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA

Joseph R. Glessner

Continued here:

A first update on mapping the human genetic architecture of COVID-19 - Nature.com

The Mellon Foundation awarded $150,000 to Knox College for a research project entitled Pedagogies, Communities, and Practices of Care after COVID-19. Cate Denial, Bright Distinguished Professor of American History, chair of History, and director of the Bright Institute, is the principal investigator.

Over the past two years, administrators, faculty, and staff have held higher education together with willpower and determination in the face of a global pandemic. The result, for many, has been burnout and exhaustion. This project responds to that crisis with a plan to identify, cultivate, and support national leadership in applying practices of compassion and care to working conditions in higher education. Denial will coordinate 36 individuals from community colleges, four-year institutions, regional states, and flagship research institutions, including online educators. These individuals, representing diverse social identities, will explore the meaning of, and opportunities within, a practice of care in the academy.

Im so grateful for the encouragement and support of the Mellon Foundation in funding this project, said Denial. Care and compassion offer a strong foundation from which to build, change, and rethink community as the pandemic continues. Faculty and staff working conditions are student learning conditions, making it particularly important to think critically about the ways in which we labor, and new approaches to work that will increase accessibility, employ trauma-informed practices, and evolve our pedagogies to affirm that care is at the center of what we do.

View post:

Pedagogies, Communities, and Practices of Care after COVID-19 - Knox College

This story contains descriptions of stillbirths.

ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up for Dispatches, a newsletter that spotlights wrongdoing around the country, to receive our stories in your inbox every week.

Late one afternoon last October, Dr. Shelley Odronic sat in her office and, just as she had thousands of times before, slid a rectangular glass slide onto her microscope.

A pathologist who works in rural Ohio, Odronic leaned forward to examine tissue from the placenta of a woman who had recently given birth. She increased the magnification on the microscope. Never had she seen so many tiny, congealed reservoirs of blood or such severe inflammation of the tissue, a sign the placenta had been fighting an infection.

Right away, I knew it wasnt compatible with life, Odronic said.

She asked her secretary to print out the patients chart. In dark letters were the words fetal demise. A stillbirth, the death of a fetus at 20 weeks or more of pregnancy. But that didnt solve the mystery. Odronic had examined many placentas from pregnancies that ended in stillbirth. None looked like this withered and scarred.

Odronic kept reading. No chronic medical conditions. Good prenatal care. Then, buried in the middle of the report, she spotted something. Seven days before the stillbirth, the mother had tested positive for COVID-19. Odronic wondered if the virus could explain the damage to the placenta. In the world of placenta pathology, a new affliction is unusual, especially one so dramatic in presentation and so devastating in effect.

Her mind traveled to Dr. Amy Heerema-McKenney, a pathologist at Cleveland Clinic and an expert on the placenta, who had trained Odronic during residency. Odronic went to sleep that night with a pit in her stomach and a plan to call her former teacher in the morning.

Heerema-McKenney was in her office when the phone rang. As she listened, she knew that what Odronic was describing was what she and her colleagues had observed repeatedly over the past several months: a patient positive for the coronavirus, a placenta destroyed by COVID-19, a baby stillborn.

Their next discovery was equally stunning. None of the stillbirths they studied involved a pregnant person who had been fully vaccinated. The doctors checked with colleagues across the country and around the world. The fatal pattern held.

Unvaccinated women who contracted COVID-19 during pregnancy were at a higher risk of stillbirths. They also were more likely to be admitted to the intensive care unit, give birth prematurely or die. Yet their greatest protection the COVID-19 vaccine sat largely untouched, buried under doubt, polluted by disinformation.

How Misinformation About COVID Vaccines and Pregnancy Took Root Early On and Why It Wont Go Away

Pharmaceutical companies and government officials failed to ensure that pregnant people were included in the early development of the COVID-19 vaccine, a calamitous decision made amid the urgency of a rapidly spreading pandemic. That decision left pregnant people with little research to rely on when making a critical decision on how best to keep the babies growing inside of them safe.

At the same time that research was excluding pregnant people from vaccine trials, a full-scale assault on vaccination was unfolding online. Taking advantage of the lack of data, conspiracy theorists, anti-vaxxers and even some medical professionals spread false claims about the vaccines safety in pregnancy, leading many pregnant people to delay or refuse the vaccine. Even now, with numerous studies unequivocally announcing the safety of the vaccine for pregnant people, some doctors have failed to communicate the dangers of COVID-19 to pregnant people or the vaccines role in mitigating it.

The Centers for Disease Control and Prevention contributed to the confusion with vague early messaging about whether pregnant people should get vaccinated. While Americans lined up at pharmacies and stalked vaccine websites in hopes of securing a shot last year, pregnant people had some of the lowest vaccination rates among adults, with only 35% fully vaccinated by last November. Meanwhile, many Americans were already moving on to their boosters after federal officials that month expanded eligibility for the additional shots to anyone 18 or older. And much of the country was beginning to return to pre-pandemic life. The Sunday after Thanksgiving, for instance, set the record for the busiest day of air travel since March 2020.

November also marked a key moment in the understanding of COVID-19s impact on stillbirths. A CDC study looking at 1.2 million births in the first 18 months of the pandemic found that more than 8,000 pregnancies ended in stillbirths, including more than 270 of them in patients with a documented COVID-19 diagnosis at the time of delivery.

Although stillbirths were rare overall, babies were dying. The risk of a stillbirth nearly doubled for those who had COVID-19 during pregnancy compared with those who didnt. And during the spread of the delta variant, that risk was four times higher.

Indeed, doctors discovered that some stillbirths resulted from COVID-19 directly infiltrating the placenta, a condition they named SARS-CoV-2 placentitis. Cases were found even in people whose COVID-19 symptoms were mild or nonexistent. In some cases, however, placentas were discarded with medical waste without being tested for COVID-19, and parents never learned what led to their babys stillbirth.

COVID-19 also led to stillbirths among pregnant people who became exceedingly ill after contracting the virus. It damaged their lungs and clotted their blood, putting their babies in such severe distress that they were born before they could take their first breath.

These are pregnancies that should not have ended, Heerema-McKenney said.

She and others had tried to alert the CDC as well as maternal and state health organizations to their findings, but she said they either didnt get a response or were told they needed to collect more data and publish studies. Pathologists are experts in disease diagnosis, dealing with death and illness from the safe distance of their labs. Convincing obstetricians who met with patients daily or doctors who were making policy recommendations was a challenge.

I tried to sound the alarm. We tried so hard to get people to listen, Heerema-McKenney said. It was a really frustrating place to be as pathologists doing these autopsies, looking at these placentas and saying, God, no, not another case.

Around the same time Heerema-McKenney was examining the damaged placentas, Ginger Munro was on life support in a hospital 250 miles away in another part of Ohio.

She and her husband, Kendal, had been trying to have a child for five years. They hadnt expected that shed get pregnant in the middle of a pandemic. But when her pregnancy test came back positive in the spring of 2021, she rushed to post a picture of it in an online pregnancy group. Is it just me or can you see the 2 lines?? she asked.

The pandemic had already brought much change to their lives. Ginger, who lives in the small town of Washington Court House in southwest Ohio, quit her job as assistant nutrition director with the countys Commission on Aging. She stationed hand sanitizer throughout her house and in her car, and she only went grocery shopping early in the morning. If she noticed someone in an aisle, she skipped it.

I knew the virus was real, she said, but I was terrified to take the vaccine.

Ginger worried that the vaccines development had been rushed, and she hadnt seen any data showing it was safe for pregnant people. At this point, the CDC had not explicitly recommended the vaccine during pregnancy. Ginger already worried she was tempting fate by getting pregnant at 40; she said she didnt want to risk endangering her baby by taking the vaccine.

Besides, if it was really important, her doctor would have mentioned it, and, she said, she would have followed his advice. But, she said, he never did. Her family hadnt gotten vaccinated either. In a mostly rural county where less than half of the residents were vaccinated, they were hardly alone.

Her doctor declined to comment through a spokesperson at the hospital system where he works; the spokesperson said the hospital couldnt disseminate information about the vaccine to pregnant patients before it was recommended.

Gingers pregnancy progressed without complications. She and Kendal shared the news of a new baby with Gingers two daughters from a previous marriage. At their kitchen table, near a sign that read eat cake for breakfast, Sophia, then 14, covered her mouth with both hands while Hailee, then 18, simply beamed.

At a backyard gender reveal three months later, Gingers growing belly resembled a basketball against her tiny frame. She leaned in to kiss her husband, her long, dark hair falling onto her shoulders. Red confetti rained down on the deck.

Kendal, an aircraft maintenance and avionics manager at an airport two counties away, worked through the pandemic. In the summer, when they realized his cough was actually COVID-19, it was too late. Ginger was sick.

What the Placenta Does

The placentas job is as critical as it is clear: keep the baby alive.

For the most part, it does that well. The placenta is the first organ to develop after conception, and it connects to the fetus through the umbilical cord, which delivers oxygen. The placenta provides nourishment, expels waste and does much of the work of the fetuss lungs, kidneys and liver as they develop. The dark-red organ typically is solid, with a sponge-like texture and blood vessels that spread out like the branches of a tree.

The placenta also acts as a shield against most viruses, but when its attacked by COVID-19, the branches can collapse, killing the cells, cutting off oxygen to the fetus, leaving holes to be filled by pools of blood. In response to the infected and dying cells, inflammation and scarring spread throughout the placenta.

Unable to survive the damage to the placenta, many babies were stillborn.

Having trouble reaching her doctor, she went to two different emergency rooms. One, she said, declined to treat her with monoclonal antibodies, which research had shown can be an effective treatment for pregnant people with COVID-19. The other, which described her in medical records as an exceedingly pleasant individual admitted with symptomatic COVID-19 pneumonia, transferred her about an hour away to the University of Cincinnati Medical Center. There, records show, she was admitted with acute respiratory distress syndrome due to COVID-19.

The University of Cincinnati doctor asked Ginger and Kendal who was on FaceTime because of the hospitals COVID-19 protocols about fetal priority. Ginger made her wishes clear: Save the baby, their baby, the baby they had tried so hard to have. Kendal, who was worried about both his wife and their unborn child, said he went along with Ginger in that moment.

You were so scared, Kendal wrote in a notebook that night. We told each other over and over how much we loved each other.

They hung up so the doctors could insert a breathing tube. Before they could begin, Kendal called back three more times just to hear her voice.

Doctors put Ginger on ECMO, a form of life support reserved for the sickest patients. Kendal, Hailee, Sophia and Gingers mother and sister were later allowed in the hospital two at a time, and they prayed at her bedside nearly every night. Ginger was sedated, her face swollen and obscured by tubing, her cheeks flattened by the crush of the ventilator straps, her wrists tied down so she wouldnt accidentally pull out her breathing tube.

Her family took solace in knowing the babys heartbeat was steady and her ultrasounds were normal. The doctors gave Ginger medication to help the babys lungs mature in case she was born early. After more than 30 days on ECMO, doctors took Ginger off the machine only to put her back on the next morning. She was the first patient in the hospitals history to be placed on ECMO twice.

The plan, records show, was to deliver at 28 weeks. But the day after Ginger was put back on life support, Kendal got the call telling him the baby was on her way. As doctors prepared for the delivery in Gingers intensive care room, the family camped out in the waiting room, jittery from excitement and vending machine snacks. They talked about baby names and future family outings. They pulled the waiting room chairs together to form makeshift beds and covered themselves with blankets they brought from home.

They dont know if they actually fell asleep before a nurse burst through the doors screaming at them to follow. Shes coming! Shes coming! They didnt make it far before they were blocked by doctors and nurses, some huddled over an incubator in the middle of the hall and the rest crowded around Ginger.

Hailee tried to peer over the sea of blue scrubs to catch the first glimpse of her little sister. She smiled beneath her black mask. Shell be OK, she said to herself.

But after a few minutes of trying to revive the baby, a doctor told Kendal it was time. Kendal nodded, asked for a chair and collapsed as he tried to process his daughters death.

Then another wave of grief washed over him. Someone would have to tell Ginger.

Content Warning

Warning: The following image shows a stillborn baby. The Munro family had photos taken of their daughter to preserve their memory of her.

Gingers medical records describe a baby born at 27 weeks without signs of life after an uncomplicated delivery. Her placenta had separated from the wall of the uterus, the risk of which studies have shown increases with COVID-19.

When Ginger woke up, she looked down at her sunken belly and realized she had given birth. She assumed her daughter was in the newborn intensive care unit. Ginger was barely able to speak around the tube in her trachea, but after a few days in which no one brought the baby to her, she couldnt wait any longer. Ginger turned to her mother and sister and mouthed the words, Wheres the baby?

The room fell silent. They called Kendal, who rushed to the hospital. He told her what had happened. He described their daughters dark hair and her long fingers and toes, just like her mothers.

Ginger, who had always loved the sweet smell of a newborns breath, whispered to her husband.

Did you smell her breath?

She wasnt breathing, he said.

In the hurried quest for a safe and effective COVID-19 vaccine, pharmaceutical companies and government officials did not include pregnant people in their initial plans. Its a failure that continues to reverberate.

They absolutely should have been included in COVID vaccine trials from the beginning, said Kathryn Schubert, president and CEO of the Society for Womens Health Research, a Washington, D.C.-based nonprofit that advocates for the inclusion of women in research and clinical trials.

Researchers and advocates have spent more than four decades trying to dismantle the belief that its unsafe or unethical for pregnant women to participate in clinical trials. A couple years ago, it seemed like they had finally prevailed.

Shortly before leaving office, President Barack Obama signed into law the 21st Century Cures Act, which established the Task Force on Research Specific to Pregnant Women and Lactating Women. The group found longstanding obstacles, including liability concerns, to including pregnant and lactating people in clinical research. It concluded that recommending halting medication or forgoing treatment while pregnant may actually endanger the health of the mother and her fetus more than the treatment itself.

The need for everything from asthma to depression medication doesnt stop when a person gets pregnant, and when a catastrophic event such as a pandemic hits, experts said, pregnancy should not preclude someone from receiving life-saving treatment.

Around the same time, researchers discovered that the Zika virus, which was mainly transmitted through mosquitoes, could pass from a pregnant person to their fetus and cause severe birth deformities. A second group of experts joined together to develop separate guidance on including pregnant people in the research, development and deployment of pandemic vaccines.

Both groups pushed to remove pregnant women from a list of vulnerable populations that required additional review before being allowed to participate in research. Instead of proving that pregnant women should be included, manufacturers would need to provide compelling evidence for why they shouldnt.

In 2018, the federal task force issued recommendations calling for including pregnant and breastfeeding people in biomedical research, and the Department of Health and Human Services adopted some of the guidance. But a gap remained between what the task force and others insisted was needed and what was actually happening.

We were frustrated because COVID-19 provided an opportunity to implement the recommendations of the task force, said Dr. Diana Bianchi, the director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the chair of the task force.

In February 2021, Bianchi and her colleagues published an article lamenting the exclusion of those who were pregnant or breastfeeding from the initial COVID-19 vaccine clinical trials. Pregnant and lactating persons should not be protected from participating in research, but rather should be protected through research, they wrote.

Ruth Faden, the founder of the Johns Hopkins Berman Institute of Bioethics, helped lead the group that issued the guidance after Zika. She and others urged manufacturers to include pregnant people in the development of the COVID-19 vaccine as part of Operation Warp Speed, the federal program that provided billions of taxpayer dollars to pharmaceutical companies to speed up vaccine production.

There is a playbook in place so that when the U.S. launches Operation Warp Speed, it should be pretty obvious what should be done, she said. Its not like no one knows how to do this, either ethically or technically.

Nevertheless, it doesnt happen, Faden added. Once again, pregnant people are left behind.

A spokesperson for Pfizer said the company followed guidance from the Food and Drug Administration. Although pregnant people were not included in the initial vaccine clinical trials, Pfizer tested its vaccine on pregnant rats and did not identify any safety concerns. The company subsequently launched a clinical trial with pregnant women but halted it because at that point the vaccine had already been recommended for pregnant people.

Similarly, Moderna also studied its vaccine on pregnant animals, but the company said it made the decision to prioritize the study of the safety and efficacy of the vaccine in adults who werent pregnant. It called that approach consistent with the precedent to study new vaccines in pregnant women only after demonstration of favorable benefit and risk in healthy adults.

In response to questions from ProPublica, Johnson & Johnson referred a reporter to its website, which didnt address the relevant issues.

Some government officials, including several from the Food and Drug Administration, said they support having pregnant women take part in clinical studies of vaccines for emerging infectious disease, including COVID-19. A spokesperson for the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health, said the agency did not dictate the protocol development for the trials and said that responsibility lies with the companies.

The failure to include pregnant people early on in COVID-19 vaccine trials was, at least in part, a casualty of the tremendous urgency to respond to an intense public threat and develop the vaccine as quickly as possible, Faden said. But multiple groups had published road maps on how to ethically include pregnant people without slowing down that process.

I cant tell you how many pregnant people might not have died or how many stillbirths might not have occurred if the playbook had been followed, she said, but Im willing to bet it was a significant chunk that would have been prevented if there had been a full-throated, evidence-based recommendation for COVID-19 vaccines in pregnancy almost simultaneous to when it was available for the rest of the adult population.

By the time the CDC specifically recommended the vaccine for pregnant people, in August 2021, the damage had been done.

A dizzying and vague series of advisories led to confusion and delayed vaccinations. When the COVID-19 vaccines were first made available in December 2020, the CDC said health care workers and residents of long-term care facilities should be prioritized, but the shots were not explicitly recommended for pregnant people. Instead, the agency said on its webpage for vaccines and pregnancy that pregnant health care workers may choose to be vaccinated. In explaining that decision, the CDC said that experts had considered how mRNA vaccines, which do not contain the live virus, work. They concluded that the vaccines are unlikely to pose a risk for people who are pregnant.

However, the CDC added, the potential risks of mRNA vaccines to the pregnant person and her fetus are unknown because these vaccines have not been studied in pregnant women.

In January, the World Health Organization recommended against pregnant people getting the vaccine unless they faced increased risk, such as complicating comorbidities or exposure to the virus due to a job in health care, but the agency later reversed course.

A few months later, in March 2021, the CDC continued its lukewarm messaging that pregnant people may choose to be vaccinated. The agency listed some points for pregnant people to consider discussing with their health care providers, starting with how likely they are to be exposed to COVID-19.

After a promising study showed that the vaccine was safe for pregnant people, CDC Director Dr. Rochelle Walensky said at a White House briefing in late April that the CDC was recommending the vaccine for them. But the CDC did not update its website to reflect her comments and said the agencys guidance had not changed: Pregnant people may choose to be vaccinated.

Once again, pregnant people were put in the precarious position of receiving ambiguous and inconsistent recommendations. In May 2021, the CDC reiterated that pregnant people faced an increased risk of getting severely ill from COVID-19, but the language surrounding the vaccine If you are pregnant, you can receive a COVID-19 vaccine was noncommittal.

A CDC spokesperson, responding to questions from ProPublica, said in an email that pregnant people were part of the first recommendations in December 2020 that encouraged people 16 and older to get vaccinated. At that time, data about the safety and efficacy of the vaccine during pregnancy was limited because pregnant people had been excluded from pre-authorization clinical trials, so the CDC included additional supporting language for pregnant people, saying they were eligible and could choose to receive the vaccine. The agency said its recommendations were based on available evidence and evolved throughout the pandemic.

Before making changes to its guidance, the CDC had its team of scientists review available data to ensure that there was an abundance of evidence.

For each update to the statement of risks during pregnancy, multiple types of studies and the strength of evidence for each were reviewed, another CDC spokesperson said. These reviews of the evidence were accompanied with discussions among subject matter experts both internally and externally with clinical partners for an ultimate determination of risk.

Dr. Cynthia Gyamfi-Bannerman, a perinatologist and chair of the department of obstetrics, gynecology and reproductive sciences at the University of California, San Diego School of Medicine, shared the daunting task of making vaccine recommendations for pregnant people as part of COVID-19 task forces for two leading organizations, The American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine.

In the beginning, she said, the only pregnancy-specific data they had came from a few dozen participants who were inadvertently included after becoming pregnant during the clinical trials and from some pregnant animal data.

It played out in real time in the COVID pandemic because we see the effects of not including pregnant people in these trials, Gyamfi-Bannerman said. We couldnt make a strong recommendation, so pregnant people were hesitant. I think that directly led to fewer people using the vaccine than we would have wanted.

At the end of June 2021, the CDC added a general update to its website to reflect the dangers of the delta variant tearing across much of the country. Getting vaccinated prevents severe illness, hospitalizations, and death, it wrote. Unvaccinated people should get vaccinated and continue masking until they are fully vaccinated.

But it wasnt until Aug. 11, eight months after the first vaccine was administered, that the CDC issued its formal recommendation that pregnant and breastfeeding people get vaccinated.

The vaccines are safe and effective, Walensky said in a statement at the time, and it has never been more urgent to increase vaccinations as we face the highly transmissible Delta variant and see severe outcomes from COVID-19 among unvaccinated pregnant people.

August would prove to be the deadliest month for COVID-19-related deaths of pregnant people. The CDC issued an emergency call the next month strongly recommending the vaccine to pregnant people, noting that approximately 97% of pregnant people hospitalized with COVID-19 were unvaccinated. The dangers to symptomatic pregnant people included a 70% increased risk of death, and their developing babies could face a host of perils, including stillbirths.

Researchers have yet to determine exactly why some pregnant people with COVID-19, vaccinated and unvaccinated alike, deliver stillborn babies, while others do not. Attempts to answer that question have been hindered, in part, by incomplete data. The CDCs statistics on COVID-19-related fetal and maternal deaths are undercounts. The CDC has data on less than 73,000 birth outcomes following a mothers confirmed COVID-19 diagnosis in 2020 and 2021, of which 579 were pregnancy losses.

That information was sent in by fewer than three dozen health departments, and those estimates dont include states like Mississippi, which in September reported 72 COVID-19-related stillbirths since the start of the pandemic, nearly double what the state would have expected, according to data from the Mississippi State Department of Health. Preliminary state data shows total stillbirths increased there in 2020 then dipped in 2021, but were still higher than pre-pandemic numbers.

A separate CDC database shows more than 220,000 COVID-19 cases and at least 305 deaths among pregnant people.

CDC recognizes that pregnant people faced challenging decisions about how to best protect themselves in the setting of uncertainty related to both the infection and the COVID-19 vaccine, a CDC spokesperson said, adding, COVID-19 vaccination remains one of the best ways to protect yourself and your family from serious illness from COVID-19.

Heartbroken and determined, Jaime Butcher has emerged as an unofficial ambassador for the vaccine, posting in online pregnancy and stillbirth forums about the risks of being pregnant and unvaccinated.

No one, she said, told her of the risks. Doctors, the CDC and health officials, she continued, arent doing enough to inform people. Even now, well into the pandemics third year, the message still isnt getting through.

I kept seeing it happening more and more to women and it wasnt talked about, she said. They just say, Oh, get the vaccine, which is great, but they dont talk about what getting the virus can do to pregnant women.

As a wedding planner, Butcher was surrounded by love. She found it with her husband, then in the daughter growing in her belly, who they named Emily after Butchers grandmother.

Read the original here:

God, No, Not Another Case. COVID-Related Stillbirths Didn't Have to Happen. - ProPublica

For a study, researchers sought to conduct a web-based survey (MarchJuly 2021) to investigate ICU visiting practices before the pandemic, during the peak of COVID-19 ICU admissions, and at the survey response time. They sought information on visiting policies and modes of communication, including virtual visiting (videoconferencing). Investigators received 667 valid responses from ICUs across all continents. Before the pandemic, 20% (106/525) of facilities had unrestricted visiting hours, while 6% (30/525) did not permit in-person visits. At its peak, 84% (558/667) of facilities did not permit in-person visits for COVID-19 patients, compared to 66% for patients without the virus. This proportion had decreased to 55% (369/667) when the survey results were reported. About 53% (354/646) of respondents reported a government mandate restricting hospital visits. Most intensive care units (55%, 353/615) provided regular telephone updates; 50% (306/667) conducted formal meetings and discussions regarding prognosis or end-of-life via telephone. Virtual visiting was available in 63% (418/667) of instances at the time of the survey. During the epidemics early stages, extremely restricted visiting restrictions were implemented. These policies were gradually relaxed but did not revert to the standards before the pandemic. As a result, the telephone has overtaken virtual visits as the primary mode of patient communication in most intensive care units.

Source sciencedirect.com/science/article/pii/S088394412200079X

Go here to see the original:

Covid-19 Pandemic: Variation in Communication & Family Visiting Policies in Intensive Care - Physician's Weekly

The COVID-19 pandemic is not over. Despite the success of safety protocols and life-saving vaccines, vaccine inequality has allowed dangerous variants to develop, threatening the lives of people everywhere.

Now, the Centers for Disease Control and Prevention (CDC) warns that the BA.5 variant is now the dominant strain of COVID-19 in the United States and has led to a surge in cases and hospitalizations.

I completely understand the frustration and the pandemic fatigue; Im feeling it, and I know other health care professionals are too, Dr. Purvi Parikh told Global Citizen. But the reality of the situation is, the virus is still here and were still seeing a lot of new cases.

Parikh is an immunologist based in New York City, where shes been involved with the COVID-19 vaccine trials at New York University since the beginning of the pandemic. Over the past few months, she has personally diagnosed patients with COVID-19 every single day.

More than 78% of Americans are at least partially vaccinated, but the latest wave of cases is making it difficult to know who is most at risk of contracting a serious case of COVID-19. For this reason, Parikh spoke to Global Citizen about adjusting to life with COVID-19 and how booster shots can help end the pandemic globally.

According to a poll from the Pew Research Center conducted between January and May of this year, fewer Americans think COVID-19 is a major threat to public health than at the beginning of the pandemic. Meanwhile, current data about the BA.5 variant suggests that it is the most contagious strain of COVID-19, with the added bonus of being able to partially evade immunity from past infection and vaccination.

One thing I want to clarify (thats a big misconception) is that the current variant is not mild, Parikh said. We are seeing an uptick in hospitalizations and deaths, though mostly in unvaccinated individuals.

Pandemic fatigue has led some people to take risks they would not have taken before, such as forgoing masks or ignoring symptoms. Though fully vaccinated individuals may experience more protection than those who have not received a COVID-19 vaccine, the risks of contracting the virus still exist. This means that getting a booster shot is more important than ever.

Dont underestimate this virus even if youre fully vaccinated because everyones risk profile is different. If youre immunocompromised, elderly, have heart disease youre still at high risk, Parikh added.

Additional risks that come with contracting COVID-19 are becoming clearer as health care professionals learn more about the virus. Parikh, in particular, is studying long COVID, or the illness in which people who have recovered from COVID-19 experience lingering symptoms.

Some of Parikhs patients plagued by long COVID report neurological symptoms like brain fog, loss of taste and smell, and prolonged ringing in their ears. Others are experiencing extreme fatigue, difficulty breathing, heart palpitations, and nausea, months or years after their initial diagnosis of COVID-19.

Its only been two years so we dont really know the long-term effects [of COVID-19], Parikh said. But there are centers around the country studying long COVID.

Parikh shared that sensationalist headlines can make it seem like booster shots are futile when up against contagious subvariants, but the data doesnt lie. According to the CDC, hospitalization rates are 4.6 times higher for unvaccinated adults than for those who are up to date with their COVID-19 vaccination.

The boosters still protect you against hospitalization, death, and the people were mostly seeing getting admitted to hospitals havent gotten their boosters, or havent gotten vaccinated at all, Parikh said.

Like many other vaccines, the COVID-19 vaccines lose part of their efficacy over time, but that doesnt mean they arent effective at all. Ongoing research and clinical trials prove that receiving an additional dose of the vaccine after the initial two-shot series improves immunity, keeping people from getting extremely sick.

The doctor also pointed out that antibodies arent the only factors to consider when it comes to immunity.

T cells [which are part of the immune system] are much more important for fighting viruses than antibodies and are still very effective against the newer variants, she said. You need that T cell immunity to keep you off a breathing machine in the ICU, to keep you from dying, or from getting bad complications.

Guidance about the COVID-19 vaccines cannot rely on a one-size-fits-all approach, which is why Parikh underscored the importance of speaking with a physician about your personal risk of COVID-19. Depending on your age and health status, getting one or two booster shots may be the best way to protect yourself and others.

[Boosters shots] are very effective, especially if youre in a high risk group. Most people should have a third [dose of a COVID-19 vaccine], and some people should have a fourth depending on their risk profile, Parikh said.

Additionally, getting a booster shot now can help end the pandemic faster. According to Our World in Data, only 19.9% of people in low-income countries have received at least one dose of a COVID-19 vaccine, compared with 80% in wealthier nations. If COVID-19 continues to spread globally, newer variants will keep developing, putting more people at risk.

One of my favorite sayings from the UN Foundation is: An outbreak anywhere is an outbreak everywhere. This pandemic is case in point, Parikh said. The quicker everyone gets their vaccine, the quicker everyone is protected.

COVID-19 has been a scary, daily part of life for the past two years. While we cant let our guard down just yet, its important to recognize just how far weve come.

Were in a much better place than we were two years ago, Parikh said. If someone is diagnosed with COVID, I can treat them with an antiviral right away.

She added: The other good news is the vaccine. If you get sick, [being vaccinated] reduces your chances of death and hospitalization significantly.

Parikh also shared that clinical trials are continuously taking place, helping health care professionals get one step closer to ending the pandemic. Until we get there, however, we all have to do our part to protect each other.

Be up to date with your vaccines, whether thats with one booster or two boosters. Wash your hands, wear a high quality mask, and have a plan in place if you get sick because we do have the tools to fight this virus, she said. If you take these precautions, you can still live your life normally.

This article is part of a series focused on vaccine hesitancy funded by the Rockefeller Foundation.

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What a Vaccine Researcher Wants You to Know About COVID-19 Boosters - Global Citizen