March 2022 – Page 20

How the new Covid-19 variants could pose a threat to vaccination

Posted on March 25, 2022 by bamdj

We knew it was going to be a long, dark winter. But unfortunately, it’s now looking even more grim. Just as the first coronavirus vaccines began rolling out in the US and countries around the world in December — offering hope for the end of the Covid-19 pandemic — two fast-spreading variants of the SARS-CoV-2 virus were discovered in the United Kingdom and South Africa.

Within a matter of weeks, the new variants replaced other versions of the virus in some regions. Scientists say these variants help explain the recent peak in cases in the UK and South Africa that have forced new and tough social distancing measures. They’re also proliferating around the world. As of January 17, the UK variant had been found in 60 countries, and the South Africa variant in 23, according to the World Health Organization.

“It’s scary, isn’t it?” said Richard Lessells, a University of KwaZulu-Natal infectious disease specialist in Durban, South Africa, who co-discovered the South Africa variant. “I’m a Scotsman so talking about my emotions doesn’t come to me naturally but I have a lot of anxiety at the moment.”

All viruses mutate as they move through populations, and until recently, the mutations in SARS-CoV-2 weren’t cause for much concern. (A mutation is a change in the genetic makeup of a virus while a variant is a virus that has a suite of mutations that alter how it behaves.)

B.1.1.7 in the UK and 501Y.V2 in South Africa each have a startling number of changes in the virus’s spike protein, the part that fits into the receptor in human cells, allowing it to infect people — and these changes may be why the new variants are seemingly more contagious than earlier versions of the already contagious virus. (There’s already increasing alarm over variants that have emerged in California and Brazil — and these are just the ones we know about right now.)

While there’s no evidence they cause more severe disease, more cases mean further stress on hospitals and, after that, a rising death rate.

And some researchers have another, pressing worry: These mutations could render the current Covid-19 vaccines less effective. Or they could mean the virus eventually “escapes” them all together. That’s why doctors, virologists, and other health researchers are calling on officials to “vaccinate 24/7 like it’s an emergency,” as Scripps Research scientist Eric Topol said on Twitter. “Because it is.

While vaccine manufacturers like Pfizer and BioNTech say their technologies can readily adapt to changes in the virus, we’re still learning about how the shots will work in this new context — and the mutations in South Africa’s 501Y.V2 are causing particular concern.

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As the virus continues to spread and more people are infected, the likelihood of even more dangerous mutations happening rises. So too does the threat the mutations pose to the vaccines. So, without drastic countermeasures, the variants could herald a new, potentially even more difficult, chapter in the pandemic.

Why the new Covid-19 variants are different — and more worrisome — when it comes to the vaccines

Scientists have warned that it was always possible the coronavirus could evolve to evade the Covid-19 vaccines that have been approved so far. The arrival of the UK and South Africa variants may be a step in that direction, increasing the odds of the vaccines becoming less effective over time.

In SARS-CoV-2, the main mutations scientists care about are on the spike protein of the virus — the part that allows it to enter human cells. This is also the protein that Covid-19 vaccines currently available in the US (from Moderna and Pfizer/BioNTech) are designed to imitate. About 4,000 mutations in the SARS-CoV-2 spike protein have been detected at various points in the pandemic. Most haven’t altered the function of the virus and haven’t stirred worry.

In rare cases, a mutation, or several at the same time, lead to changes that give the virus a greater advantage. And that appears to be what’s happening with the UK and South Africa mutation.

The UK variant, B.1.1.7, contains 23 mutations in the genome of the virus while the South Africa variant, 501Y.V2, has at least 21 mutations, with some overlap between the two. In both cases, the changes seem to have increased the fitness of the virus, or its ability to propagate.

“[With genomic sequencing in South Africa] we can show quite clearly there were lots of different lineages circulating prior to October,” Lessells said. “Within the course of just a few weeks, this new lineage — 501Y.V2 — became almost the only lineage you’re detecting.” The story is similar in England, where one in 50 people were infected with Covid-19 as of the new year.

The fact that these mutations became so dominant so quickly suggests that they may be more contagious. Scientists in South Africa think the variant that emerged there is about 50 percent more transmissible, and one estimate suggested the UK variant is up to 70 percent more transmissible.

There could also be other more familiar variables that are driving the spread of these new variants, like holiday travel. Scientists still have to complete experiments in animals to pinpoint differences in transmissibility between these mutations and earlier versions of the virus — and to what extent shifts in peoples’ behavior might also explain the growth in cases.

But they’ve already zeroed in on concerning changes in the virus that are relevant to vaccine effectiveness. With the South Africa variant, for example, one change of particular interest is the E484K mutation in the receptor-binding domain of the virus where it latches on to human cells.

“The E484K mutation has been shown to reduce antibody recognition,” said Francois Balloux, a professor of computational systems biology at the University College London, in a statement. This means it can help the virus “bypass immune protection provided by prior infection or vaccination.”

Researchers have demonstrated how this might happen in cell culture and small human experiments. One, described in a pre-print paper (and therefore not yet peer-reviewed) on Biorxiv, looked at several generations of SARS-CoV-2 challenged with antibody-rich plasma from a Covid-19 convalescent patient and watched to see what happened. At first, the antibodies seemed to beat back the virus. But as the virus mutated, eventually making the E484K substitution, it started to proliferate in spite of the presence of the antibodies.

The senior author on the study, Rino Rappuoli, a professor of vaccines research at Imperial College and chief scientist at GSK, told Vox that when he and his colleagues first ran the experiment, they didn’t know how relevant their findings would be. “But when the South Africa and UK variants came along, we looked at [our data] and saw that, in real life, the first steps of what we saw in vitro are happening.” (GSK has a Covid-19 vaccine in clinical trials with the drugmaker Sanofi.)

Other scientists are coming to similar conclusions. In a second preprint, researchers tracked how mutations altered the effectiveness of the antibody response in people who had the virus. They also found E484K has antibody evasion capabilities. A third, also in test tubes involving survivor plasma from donors in South Africa, showed that antibodies from a prior infection were totally ineffective against the new variant in about half of the donors.

A couple of caveats here: These studies are in vitro, involving the specimens from Covid-19 survivors, rather than antibodies from someone who received a vaccine. We don’t yet know how people in clinical studies who got a vaccine will respond to the new variants.

Still, Rappuoli said, the findings are cause for concern nonetheless. “If given enough time under immune pressure, this virus has the possibility to escape.”

Another preprint study, from researchers in Brazil, recently provided an alarming example of how this could play out. The paper documents the case of a 45-year-old Covid-19 patient with no co-morbidities: months after her first bout with the illness, she was reinfected with a version of SARS-CoV-2 that had the E484K mutation — and experienced more severe illness the second time around. It’s limited evidence, but it suggests that surviving an earlier SARS-CoV-2 infection isn’t a guarantee of protection against variants with this mutation.

“The finding of the E484K, in an episode of SARS-CoV-2 reinfection might have major implications for public health policies, surveillance and immunization strategies,” the authors wrote.

Researchers are racing to figure out how vaccines work against the variants

So what does this mean for the vaccine rollout effort? Will pharmaceutical companies have to tweak their existing vaccines to fight the new variants?

“It is one of the key questions that we are trying to find answers to at the moment, and we have groups around the country working around the clock to get a better understanding of this,” said Lessells. “This also involves collaboration with other groups around the world, with groups running the vaccine trials, with vaccine developers.”

Rappuoli said even if there’s no evidence yet showing the variants can outsmart the immune response created by vaccines, “we should be prepared that at some point in the future that may happen,” he added. For Fred Hutch Cancer Research Center scientist Trevor Bedford, that point could come as early as autumn this year:

Vineet Menachery, a coronavirus researcher at the University of Texas Medical Branch, said the laboratory experiments on SARS-CoV-2 variants represent “the worst-case scenario.”

The currently available vaccines in the US — from Pfizer/BioNTech and Moderna — help the immune system target multiple areas of the spike protein, so the virus would have to change drastically to completely escape the immune response generated by the vaccines. He called the odds of this happening “unlikely but not impossible.”

The diversity of immune responses at the population level gives University of Utah evolutionary virologist Stephen Goldstein some comfort, too. “Our immune systems have evolved to deal with antigenic drift — or the selection of different variants of circulating viruses,” he said. “I’m not worried vaccine efficacy is going to fall off a cliff and go from 95 percent to zero.”

The incoming Centers for Disease Control and Prevention director, Rochelle Walensky, also took comfort in the very high rate of protection the vaccines already have. “The efficacy of the vaccine is so good and so high, that we have a little bit of a cushion,” Walensky said in a January 19 interview with JAMA.

And if the vaccines do turn out to be less effective against the new variants, vaccine developers say they’ll be up for the challenge of adapting them. That’s because the new platforms they’re using can be modified easily to counter new threats.

Vaccine developers say they can adapt their technologies fast

The Pfizer/BioNTech vaccine and the Moderna vaccine both use a molecule called mRNA as their platform to deliver instructions for making the spike protein of SARS-CoV-2. Meanwhile, the vaccine developed by the University of Oxford and AstraZeneca that recently received approval in the UK (but not yet in the US) uses a reprogrammed version of another virus, an adenovirus, to shuttle DNA that codes for the SARS-CoV-2 spike protein.

Human cells then read that DNA or mRNA genetic information and manufacture the spike protein themselves, allowing the immune system to use it for target practice. An advantage of using this approach is that vaccine developers only need to modify DNA or mRNA to tweak the vaccine, something they can do quickly and easily if necessary.

In a January 19 preprint, BioNTech and Pfizer found the UK’s variant may not pose as much of a threat to their vaccine: Antibodies in blood samples from people who got the shot appeared to work against the B.1.1.7’s mutations, making it “unlikely” the variant will escape the vaccine. If a stronger viral foe comes along, BioNTech’s chief executive Ugur Sahin told the FT, “we could manufacture a new vaccine within six weeks.”

These new vaccines would not necessarily require developers to go through every regulatory hurdle again, former FDA chief scientist Jesse Goodman told Vox in December. Instead, new versions of Covid-19 vaccines could end up going through an approval process similar to vaccines for seasonal influenza — with some initial testing but stopping short of massive clinical trials. That means revised Covid-19 vaccines could potentially roll out quickly.

Lessells was cautiously optimistic for another reason: Even if the current vaccines stop working as well as earlier clinical trials suggested, he said, “There are many vaccines in development. So as we learn more about this virus, the vaccine developers also learn from that, and different vaccines may be developed.”

But while it may be possible to alter the vaccine to adapt to new mutations, it’s not ideal: It would require expensive changes in the vaccine production process and eat up valuable time that could be used to inoculate more people during a devastating pandemic.

“From a cost and manufacturing perspective, it would put us far, far behind,” said Anna Durbin, a vaccine researcher and a professor of international health at the Johns Hopkins School of Public Health.

Now’s the time to drive down case numbers and vaccinate

That’s why researchers and health officials are hoping to drive down case numbers and rapidly build up herd immunity with the existing vaccines while also getting ready for changes to the virus that may lay ahead.

To track mutations and understand how they may impact vaccine effectiveness, governments also need to invest more in genomic sequencing, Lessells said. And right now, “there’s a lot of variability around the world in how much sequencing is being done and how people are using sequencing.”

Inadequate sequencing of SARS-CoV-2 genomes may create blind spots where new mutations could be lurking. Infectious disease experts told Stat’s Helen Branswell that the US doesn’t sequence enough and may be unaware of how widespread the UK variant is because of that. According to Lessells, the UK sequences about 10 percent of its cases — on the high end of sequencing volume globally — while the number in South Africa is closer to 1 percent.

Of course, there’s another way to prevent dangerous mutations from arising: preventing cases from happening at all through mask-wearing, social distancing, rapid testing, and treating and isolating infected people. The virus can’t mutate if it’s not replicating inside lots of people.

“The bottom line hasn’t changed: We need to suppress the amount of viral transmission as much as we can,” Goldstein said. Vaccines are a part of that suppression effort, but social distancing and masks are too. According to Salim Abdool Karim, chief adviser on Covid-19 to the South African government, social distancing measures in the country appeared to be bending the curve. “Outbreaks grow exponentially and you’re not going to vaccinate at an exponential rate,” he added. “But you can bring outbreaks down to a rate where they are not growing exponentially.”

For now, the emergence of the worrisome mutations is a reminder that, despite our collective fatigue, there’s still a long road ahead, Lessells said.

“We keep passing these milestones — going into a new year, having Christmas — and thinking that the virus is going to suddenly do something different because we are celebrating or whatever. Of course, that’s not the case. We are still in the early days. We are still learning about this virus.”

The evidence that Covid-19 vaccines are safe and effective in pregnancy is growing

Posted on March 25, 2022 by bamdj

People who are pregnant are now eligible to get the coronavirus vaccine in more than 40 states — typically ahead of their lower-risk peers. And more than 60,000 of them have already rolled up their sleeves, according to the Centers for Disease Control and Prevention.

Although the Covid-19 vaccines authorized in the US were not studied in pregnancy, early data is now starting to emerge suggesting — as researchers expected — that the vaccines are likely safe during pregnancy and confer protection not only to the recipient but also, potentially, the baby.

“It’s all very positive,” says Stephanie Gaw, a maternal-fetal medicine specialist at the University of California San Francisco Medical Center, of the findings so far.

There have been many reasons to suspect the vaccines should be safe in pregnancy, including the lack of major adverse events reported so far, solid studies in animals, and a good understanding of how the vaccines work in the body (they don’t contain live virus, and they are quickly broken down). “The data that we’re collecting on it so far has no red flags,” Anthony Fauci, the top US infectious disease doctor, said in February.

Meanwhile, new research, published March 25 in the American Journal of Obstetrics and Gynecology, found that the vaccines offer strong immune protection for people who are pregnant, just like their non-pregnant peers.

Preliminary research also suggests vaccines might provide some protection to newborns, who are unlikely to have their own approved Covid-19 vaccine anytime soon (and are also vulnerable to more severe illness). The new AJOG paper joins other early findings that antibodies to Covid-19 generated by pregnant mothers after receiving their vaccines were passed through the placenta to the fetus.

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But Covid-19 vaccine rollout to the pregnant population has been inconsistent around the globe.

For months, the US and many national medical groups — including the American College of Obstetrics and Gynecology, the Society for Maternal-Fetal Medicine, and the Academy of Breastfeeding Medicine — say the vaccine should be offered to this group, in large part because there’s strong evidence that pregnancy elevates the risk for severe Covid-19 and death. (Given this data, the American Society for Reproductive Medicine goes so far as to say the vaccine is “recommended” for those who are pregnant or considering pregnancy.)

“If a pregnant patient gets infected during pregnancy, her risk of intensive care admission is around 5 percent,” says David Baud, chief of obstetrics at Le Centre hospitalier universitaire vaudois in Switzerland, where he studies infections during pregnancy. “I do not know of any disease that put a 30-year-old woman at such high risk to be admitted to the ICU.” Furthermore, if the infection happens late in pregnancy, it increases the risk of preterm birth and the baby needing intensive care.

Israel went as far as adding pregnant women to its vaccine priority list in January. But other countries, such as the UK and Germany, and the World Health Organization are still saying most people who are pregnant should wait.

Why the disagreement? The clinical trials of the new Covid-19 vaccines explicitly excluded pregnant people, and we don’t yet have enough follow-up data from individuals who have opted to get the shots to say for sure they are safe for everyone during pregnancy.

Add to this muddled landscape the persistent misinformation swirling around the Covid-19 vaccines and pregnancy and fertility, and it is little wonder some people are still confused or worried. And most organizations still stop short of advising all pregnant people to definitely get the vaccine.

Thankfully, these information gaps are starting to fill in. Numerous studies are underway following the outcomes of pregnant and breastfeeding people and their offspring after immunization. And a handful of them are now starting to report early, reassuring results.

In the meantime, however, a growing number of people have had to come to their own decision, with the optional help of their care provider, with some uncertainty. And no one needs an extra thing to stress about during a pandemic pregnancy.

So more information about the coronavirus vaccines in pregnancy can’t come soon enough.

4 reasons the coronavirus vaccine should be okay to get while pregnant — but why not everyone is recommending it yet

One of the big reasons why, despite Covid-19’s known risks in pregnancy, not everyone has unequivocally recommended the vaccines that currently have emergency approval in the US for pregnant people is that the way they work is fairly new. But we do have some key pieces of information already:

1) These vaccines don’t contain live coronavirus. The only types of vaccines that are contraindicated in pregnancy contain live virus that has been weakened, such as the chickenpox vaccine. (Even fewer immunizations, such as the smallpox vaccine, are not recommended during lactation.) While these vaccines don’t pose a risk to most people, there is a small, theoretical chance they could cross the placenta and infect the fetus.

The Pfizer/BioNTech and Moderna vaccines, on the other hand, contain just a fragment of genetic material, called messenger RNA, that can tell human cells to build a tiny part of the virus’s outer shell, which the immune system learns to recognize and fight off. The Johnson & Johnson vaccine uses a different method, known as a viral vector (the same platform as the already-used Zika and Ebola vaccines), to get the body to build part of the virus’s shell.

In either case, there is no way the vaccine can cause a Covid-19 infection.

2) The main coronavirus vaccines are very fragile. Once the mRNA enters the body, it likely only reaches local arm muscle cells before the body breaks it down. This means it is unlikely to enter the bloodstream, and even less likely to make it as far as the placenta. Even if it does get that far, “one of the placenta’s main functions is to be an immune barrier to the fetus,” which adds another layer of protection, says Gaw. And although it contains genetic material, it doesn’t enter our cells’ nuclei, meaning that it can’t cause any mutations to our cells — or those of a developing fetus. This mRNA is so fragile, vaccine developers had to wrap it in nanolipids (which are also presumed to be safe for pregnancy) just to keep it intact long enough to reach muscle cells in the arm.

Experts also expect it is unlikely for the mRNA to make its way intact into breast milk. Preliminary research from Gaw and her team, which is in the process of being peer-reviewed, found no trace of the vaccine itself in breast milk samples from hours and days post-vaccination. And even if a small amount of it were to be transferred to a feeding baby, researchers say it (and any lipid nanoparticles) would get broken down by the baby’s stomach acids.

3) Animal studies look promising. Before any shots were given to pregnant humans, vaccine companies gathered safety data in other pregnant mammals. None of these developmental and reproductive toxicity (DART) studies from Pfizer/BioNTech, Moderna, or Johnson & Johnson suggest any safety concerns for use during pregnancy.

Rats, of course, are not humans, and DART study results do not always translate identically into humans. “Some results are similar to humans, and some are very different,“ Gaw says. Nevertheless, they are a good starting point — when combined with strong safety data in the clinical trials and public vaccinations so far.

4) We haven’t seen adverse events in pregnant people who have gotten it so far. For the Covid-19 vaccine trials, those of “childbearing potential” were screened for pregnancy before each shot, and those with positive tests were removed from the studies. However, a handful of people (12 who got the vaccine in Pfizer/BioNTech’s study and six who got the vaccine in Moderna’s study) ended up having been pregnant at the time of vaccination — and companies haven’t reported any negative outcomes from these individuals.

A newer and much larger data set is emerging from the Centers for Disease Control and Prevention, which is following pregnant people who sign up for its tracking platform V-safe after being vaccinated — and allowing them to sign up for a more targeted pregnancy-specific vaccine registry.

At the beginning of March, the CDC reported data from more than 1,800 pregnant people in the registry who had received Covid-19 vaccines. Among these individuals, there was not a statistically significant increase in adverse pregnancy or birth outcomes. Nor have they found any significant differences in side effects from the vaccine (such as fatigue or fever).

“From a scientific perspective, there’s no specific reason to think that pregnant individuals would have more adverse reactions to the vaccine or that there would be a risk to the fetus with the vaccine, while we know that there is risk with the Covid infection,” says Alisa Kachikis, an assistant professor of obstetrics and gynecology at the University of Washington.

A January study published in JAMA Internal Medicine, for example, analyzed the outcomes of more than 406,000 people who gave birth in hospitals between April and November 2020 and found that a significantly higher rate of those with Covid-19 had major complications. “The higher rates of preterm birth, preeclampsia, thrombotic [blood clotting] events, and death in women giving birth with Covid-19 highlight the need for strategies to minimize risk,” noted the authors.

So why are some, such as the WHO and the UK, still saying most pregnant people should not get the coronavirus vaccine yet? They are waiting for more data.

There are also, of course, other types of coronavirus vaccines in the works, such as protein-based vaccines (which is the basis for Novavax’s shots). This model of shot has been used for years — including for pertussis and hepatitis B — “and we are very comfortable with [their] safety profile,” Gaw says. Viral vector vaccines (which is how the Johnson & Johnson and AstraZeneca/Oxford shots work) have also been used safely in pregnancy, such as for the Ebola and Zika vaccines, although there is less historical data on these.

So, says Kachikis, if what’s hanging people up about getting a Covid-19 vaccine in pregnancy is mostly the novelty of the mRNA vaccines, having other types to choose from — as long as they’re just as effective — could be a good option.

What studies are happening, and what will they help us learn about the Covid-19 vaccine in pregnancy?

The CDC continues to monitor for any adverse outcomes and side effects through its V-safe program — and related pregnancy registry (which will check in with participants in each trimester, after delivery, and when the baby is 3 months old).

Pfizer/BioNTech started giving vaccine doses in their pregnancy-focused, placebo-controlled clinical trial this February. They are first running a smaller safety study of just 350 healthy pregnant participants before scaling up to give the vaccine to a total of about 4,000 people who are at between 24 and 34 weeks gestation. (This study design, however, will still leave some questions about the safety and efficacy of the vaccine, especially earlier in pregnancy.)

Moderna has created a registry that people can sign up for after receiving their vaccine while pregnant. For its part, Johnson & Johnson plans to conduct trials of its vaccine in pregnant participants later (likely after it studies the vaccine in children).

In the meantime, other researchers are racing to collect and study data from the natural experiment that started in December, when many pregnant people began electing to get vaccines as they became eligible because of their high-risk work in hospitals or long-term care centers.

At the University of Washington, Kachikis is leading a study to also follow vaccination in people who are pregnant. Thousands of people from around the US and the world who have received the vaccine while pregnant have already signed up for the registry, she says. (People who are pregnant or lactating but have not yet gotten vaccinated can also sign up, as can people who are considering becoming pregnant within the next two years.) This research will help them track any adverse outcomes, as well as gather additional data, such as whether any vaccinated individuals (or their newborns) later get Covid-19.

An additional large-scale clinical trial, which has not started enrolling participants, aims to track 5,000 women and their offspring over the course of 21 months. Other smaller studies are in the works as well, such as one at Duke University.

At UCSF, Gaw and her team are in the midst of separate observational studies. They will more closely follow a smaller group of participants — 100 or so of whom are pregnant and roughly 50 of whom are lactating — “to determine whether the Covid vaccines are equally effective in pregnant and lactating women, how long antibody responses last, and whether immunity is transferred to the baby,” Gaw explains.

Other vaccines are routinely given in pregnancy, such as pertussis, in large part to provide protective antibodies to the fetus and protect the newborn until they are old enough to get the vaccine themselves.

Covid-19 antibodies have been shown to transfer across the placenta in women who were positive for the virus at delivery. The new AJOG study found that even higher levels of antibodies were present in the umbilical cord after Covid-19 vaccination than after natural infection. “The research shows really promising results,” Kachikis says.

If these antibodies prove to be protective, it could be especially helpful, as newborns and infants will likely be among the last to have an authorized vaccine — and have the highest rates for complications and death from the virus among children. “There is still a lot of data that needs to be assessed, but for individuals who are thinking of ways that the vaccine may benefit their newborn, this is really encouraging,” Kachikis says.

More nuanced research might also eventually help advise on optimal timing for the Covid-19 vaccine during pregnancy. For example, Gaw notes, “there needs to be sufficient time for the mom to develop a robust antibody response, and then pass [this] to the baby.” After extensive research, the Tdap vaccine is recommended around 27 weeks of gestation so as to provide the best protection for the infant after birth. Without such information for the Covid-19 vaccine, many experts are recommending that those who decide to get the shot treat it like the flu shot — getting it as soon as it’s available to them, regardless of where they are in their pregnancy.

People who are lactating were also excluded from the vaccine trials. So researchers at a number of institutions are now working to study how the vaccine might impact breast milk contents and a nursing child. A study from October 2020 showed that most people who had recovered from Covid-19, as well as those suspected of being infected, passed on antibodies to the virus in their breast milk.

The recently released AJOG paper found a high level of antibodies in breast milk from women who had received the Covid-19 vaccine. Gaw’s team also has new findings, which are currently in peer review, that show a solid dose of Covid-19 antibodies in breast milk samples after vaccination. This, they hope, will provide some protection from the virus for babies.

“It’s all reassuring,” Gaw says. But “all the studies have been small…[so] we can’t 100 percent determine safety until a lot more people have been vaccinated and it’s been reported on.”

Wait, why weren’t pregnant people included in the early research to begin with?

Pregnancy has, for decades, been considered a “vulnerable” condition when it comes to researching new medical treatments and preventions, meaning people who are pregnant have been excluded from general trials in much the same way as have those who are unable to give informed consent, like children and those with severe mental disabilities.

Part of the reason for this might be due to the damaging legacy of thalidomide. This drug was given to pregnant women around the world starting in the 1950s as a way to ease nausea (although it was never approved specifically for use in pregnancy in the US). Soon, thousands of these babies were being born with devastating birth defects. This hammered home for scientists and the public that, when it comes to pregnant women and their fetuses, much more care ought to be taken in giving medications or vaccines.

But this conclusion, many are now saying, has it backward, as the oft-repeated phrase indicates: Protect pregnant people “through research, not from research.” If thalidomide had been carefully and systematically studied for pregnancy, it likely never would have been approved for use (or used unofficially) in this population, preventing the majority of these tragic outcomes.

“It can’t be emphasized enough that pregnant women should be included in vaccine trials from the get-go,” Kachikis says.

Gaw agrees: “We actually cause harm by not including [pregnant people] in early research, as they have to wait longer for good data to be published.”

So when will we have more data about the coronavirus vaccine in pregnancy and lactation?

One big challenge with researching anything to do with pregnancy is that it takes a long time: nine months, plus follow-up time to monitor infant outcomes. And subsequent study during lactation while you’re at it, and maybe preconception research, too.

Consider that it took vaccine makers just 10 months to develop the Covid-19 vaccines and ensure they were safe and effective in adults. But with formal studies in pregnant people just getting underway (and with many having not yet started, and others, like Pfizer’s, currently limited to late pregnancy), it could be late 2021 or beyond until we have comprehensive, robust safety data for all stages of pregnancy. And even later to assess long-term outcomes for babies.

Follow-up to the early work Gaw and colleagues are doing at UCSF will take “at least six to nine months, as we have to wait for a sufficient number of babies to deliver,” Gaw says.

Kachikis and her team at the University of Washington plan to follow the outcomes of people who sign up for their list for about a year, with hopes to continue more long-term follow-up. For example, they plan to test babies months after birth to see how long antibodies from vaccines given during gestation persist — and if these antibodies are equally as effective at fighting off the coronavirus as those found in the vaccinated adults.

But they aren’t waiting that long to start sharing what they learn. “The focus is on getting any data out,” Kachikis says. And “if multiple groups can get some data out, that will be better than having absolutely nothing,” which has been the situation, she notes.

For now, much of the official guidance in the US stresses the need for people to conduct their own analysis of the known increased risks of Covid-19 in pregnancy with the remaining unknowns of the vaccine. And this calculus is not the same for everyone.

“As more evidence is coming out, it’s tilting to more benefit of getting the vaccine,” Gaw says. “But every individual has a different level of risk they’re willing to take” — as well as the amount of risk they might have of contracting the virus or getting extremely sick from it. The bottom line, based on the latest Covid-19 vaccine research in pregnancy, she says, is that “it’s looking more and more like it does work, it does pass antibodies to the baby (although we don’t know yet how protective they are), and there doesn’t look like there’s any harm at this moment.”

Additionally, even those who are reluctant to advocate the vaccine for all pregnant people just yet, such as the WHO, do suggest it should be available to those at high risk of exposure to the virus or underlying health conditions that increase their risk of severe Covid-19.

And some might elect to wait until there is more solid data. So to help move along the plodding process, people who are pregnant and have gotten the vaccine — or are considering it — can contribute to getting more and better guidance sooner by opting in to registries and studies.

Katherine Harmon Courage is a freelance science journalist and author of Cultured and and Octopus! Find her on Twitter at @KHCourage.

Biden now promises 200 million vaccine shots in 100 days. The US is already on track for that.

Posted on March 25, 2022 by bamdj

President Joe Biden on Thursday set a new goal for Covid-19 vaccines in the US: 200 million shots in his first 100 days in office. That’s up from Biden’s original goal of 100 million in 100 days. “I know it is ambitious — twice our original goal,” Biden said.

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But the goal of 200 million shots in 100 days is really not that ambitious; it’s achievable if absolutely nothing changes with America’s current vaccine rollout.

That’s a testament to how much America’s vaccine campaign has improved since Biden took office. Before Inauguration Day, the country administered less than 1 million shots a day. Today, the US is at 2.5 million shots a day, on average.

At the current rate, the country could hit Biden’s goal of 200 million shots in 100 days — hitting the goal as soon as April 28, a couple days before Biden’s 100th day in office.

Things stand to improve beyond the current rate. As vaccine manufacturers ramp up production, they’ve already made deals with the federal government to deliver enough vaccines for every adult in the summer. At the very least, that should address questions about the supply of vaccines, though not about distribution or willingness to take them.

Biden previously pledged that the US will have enough vaccines for every adult in the US by the end of May. Getting all of those vaccines into arms will require a distribution boost: At the current rate of 2.5 million shots a day, only about 180 million adults, of roughly 255 million, will be fully vaccinated by the end of May. The US has to do more than 4 million shots a day, on average, by then to fully vaccinate every adult in the US before June.

That will be a challenge, with lots of potential factors involved: whether drug companies can ramping up manufacturing, whether the federal government can ship those vaccines out, whether local and state governments can turn those doses into shots in arms, and whether vaccine hesitancy is sufficiently addressed to get all adults to want the vaccine.

That’s a lot that could go wrong. Biden, for his part, has vowed to get ahead of these issues, dedicating more money to vaccine distribution and public education and awareness efforts, funded in part by the recently enacted Covid-19 relief package.

Now Americans waiting for a shot will have to wait and see if Biden can turn those promises into reality.

It’s been nearly a year since Julie Horowitz-Jackson’s mother, Arlene, died of Covid-19 in a nursing facility in Philadelphia. “What hit me recently is that the world is opening back up, and my mom’s still dead,” Horowitz-Jackson says.

At this point in the Covid-19 pandemic, as vaccines get rolled out in the United States and around the globe, there is a glimmer of hope that life will safely start shifting back to “normal” in the coming months. But so many people, like Horowitz-Jackson, are still working through their grief, and it won’t just disappear when the virus does. Horowitz-Jackson, 51, says she was coping well with the loss of her mom until recently, when, in Chicago, where she lives, she saw many people out and about, celebrating St. Patrick’s Day in large crowds. “I get angry,” she says. “I get angry that people aren’t taking it seriously.”

With over 550,000 reported Covid-19 deaths in the US and 2.8 million worldwide, a massive grief crisis is upon us — with large, unaddressed mental health and economic implications.

“For a large share of people, these [losses] lead to bouts of prolonged grief disorder and depression,” says Ashton Verdery, a Penn State sociologist who studies the societal costs of bereavement. “But also they have huge impacts on their finances, on their employment, on their relationships, and on all kinds of aspects of thriving in the world.”

And new research here provides a broad window onto the lasting scope of our national tragedy.

“These losses that are felt now will be felt for some time to come — even individuals who aren’t born yet will potentially be missing these relatives who might have been alive during their formative years,” says Mallika Snyder, a graduate researcher at UC Berkeley who is also working on estimates with colleagues of the “excess bereavement” felt in the United States and other countries this year.

There’s no exact figure on the amount of “excess bereavement,” but it’s likely very large, and very devastating.

So many more people are grieving this year than normal

Lately, I’ve been trying to understand the long-term consequences of the Covid-related death — the blank spaces and shadows it leaves behind. Death is not a one-dimensional statistic. It ripples across time, leaving holes in people’s present and future where their loved ones would have been. So, so many people are sensing these holes in their lives right now.

Recently, Verdery and colleagues estimated that, roughly, every person who dies from Covid-19 in the United States leaves nine grieving people behind. Since more than 550,000 people have died of Covid-19 here, then there are nearly 5 million people who’ve suffered the loss of someone close to them.

Verdery’s work is based on a statistical model of the personal connections people typically have. The Centers for Disease Control and Prevention collects data on who is dying of Covid-19, but not the survivors they leave behind.

That said, Verdery says his team’s work suggests a huge swath of people are dealing with loss. “Each death [regardless of their age at death] is going to leave a 4-year-old, a 50-year-old, a 60-year-old, a 10-year-old bereaved, on average,” he says.

And researchers know from past disasters that those losses can leave a lasting mark.

Meghan Zacher, a sociology researcher at Brown, has recently re-analyzed some mental health and wellness data collected from survivors of Hurricane Katrina, in an attempt to predict some of the long-term consequences of the pandemic. “Katrina and Covid are different in really important ways,” she stresses. “This isn’t an apples-to-apples comparison. But there really isn’t an apples-to-apples comparison to the pandemic, at least in modern history.”

She and her co-authors found that the experience of losing a relative or a friend during the storm and its aftermath had the “largest effects on mental and physical health, one year after the storm,” she says. “Also things like fearing for your loved ones’ safety had sizable impacts, as did unmet medical needs. And those are all things that people have experienced during the pandemic.”

Many people experiencing loss from death could benefit from counseling. Covid-19 swells their numbers.

The loss of a loved one is really hard, and not everyone copes in the same way. But there’s some research into the broad buckets of need grieving people fall into. And that helps us understand the immediate impact this bereavement crisis is having in the country — and around the world.

Survey research suggests that, at least in Western contexts, around 60 percent of people dealing with a loss cope by relying on friends and family to support them. “They handle it in their own way,” says Catriona Mayland, a physician and researcher at the University of Sheffield who studies end-of-life issues. It’s not necessarily easy for this group to deal with loss. But they manage.

A further 30 percent might need some more structured help. “So that might be group bereavement support from a faith-based or community-based group,” Mayland says.

And then around 10 percent of those who lose someone close to them experience symptoms qualifying them for a prolonged grief disorder, a diagnosis that soon will be included in the DSM (the psychology/psychiatry official diagnostic manual).

The diagnosis recognizes that sometimes grief rises to the level of severely interfering with the normal function of life, and that people experiencing prolonged grief could benefit from mental health care.

That 10 percent figure is both small and large. It means that, yes, most people cope with loss in their own time. But it’s also not uncommon for someone to need extra help.

And then consider the Covid-19 pandemic. Again, there could be 5 million people grieving losses due to the pandemic. If 10 percent of those people qualify for this diagnosis, that’s half a million people.

There’s even some limited research from the Netherlands suggesting losses due to Covid-19 are harder to take, resulting in more grief, compared to deaths from more typical natural causes.

Talking with people who have experienced loss, it’s easy to see why. Horowitz-Jackson’s family is Jewish, and it’s custom for the family and surrounding community of the deceased to hold a week-long open house “shiva” period, where there’s near-constant company in the home.

“Shiva Zoom was about the worst thing I’ve ever experienced,” she says. Particularly, she remembers how her father, hard of hearing, struggled with the technology. “The ritual of seeing each other and leaning on one another,” she says, just couldn’t be facilitated as well over the internet.

Mayland worries, too, that “there actually could be an upward shift” in the number of people needing more than informal support after a loss, since due to the social distancing restrictions of the pandemic, “normal support” from family and friends may be limited.

Which is all to say: More people than usual may need support to deal with their loss.

Bereavement can impact health and well-being differently at different ages

A person older than 65 who loses a spouse has a “shockingly elevated” increased risk of dying over the next year, Verdery says — estimates range from 15 to 30 percent higher risk of dying. There are many reasons: Our loved ones take care of us when we’re sick, they prod us to get checked out by a doctor, they provide emotional and sometimes financial support. When a loved one gets taken out of the picture, so many cracks can form in the foundations of our lives.

There is, quite literally, a condition called “broken heart syndrome,” or takotsubo cardiomyopathy. It’s when, in reaction to a sudden surge in stress, the heart’s left ventricle weakens.

The experience of loss can be particularly impactful on the trajectory of a life when it comes to young people: When a person under the age of 18 loses a parent, they become less likely to finish high school or college. “Because we know that education is so strongly linked to all manner of life course outcomes — like involvement in the prison system, socioeconomic status in adulthood, unemployment spells, early pregnancy, all sorts of stuff — this does suggest that some of these bereavement events might be really derailing,” Verdery says.

The impact of these deaths is so powerful that bereavement is thought to be a source of racial disparities in health and education in America. By age 20, a Black child is twice as likely to experience the death of a mother and 50 percent more likely to experience the death of a father. The pandemic is likely to make this trend worse — as we know Covid-19 has been taking minorities at younger ages than white people dying from it.

And American society doesn’t do well to protect these grieving kids. It’s estimated that less than 50 percent of children who experience the loss of a parent receive Social Security survivors benefits (which they may be entitled to). “This is one of the most staggering statistics that I found,” Verdery says. “The kids are already dealing with so much. And we’re not even getting them in touch with the benefits they’re entitled to.”

What should we do about this?

After experiencing the loss of her child, Joyal Mulheron, a former adviser to Michelle Obama’s “Let’s Move” campaign, felt the extreme, life-altering pain bereavement can bring. “I basically drove to work every day for 18 months and cried to and from work,” she says. And it wasn’t just her personal pain that was horrible — she also realized that society often overlooks bereavement issues.

Now Mulheron runs Evermore, a bereavement-focused nonprofit, and hopes the pandemic will be a wake-up call for the country to start paying closer attention to the societal strain bereavement puts on the country. “The challenge is no one is thinking about it as an event that can change the course of an individual’s life,” she says.

For instance, she points out that “bereavement is not part of the FMLA” — the Family and Medical Leave Act, which provides time off for those caring for sick family members, but not to cope with their loss. She calls for better housing protections for those who lose financial support after losing a loved one, more transparent funeral pricing, and better Social Security assistance for kids who lose parents.

She also simply would like to see this issue be studied more thoroughly. “We’ve not had the data to really contextualize this,” Mulheron says. “We’ve really thought of a death event as a personal tragedy, rather than a family or a community experience.” At the very least, Mulheron would like to see the White House establish an Office of Bereavement Care, to set a national agenda on this issue.

On a smaller scale, Mayland, the physician who studies end-of-life issues, says it can be helpful just to find spaces to talk about grief, and more helpful still if friends and family reach out with an ear to listen. “Sometimes it’s therapeutic to be able to tell a story,” she says.

“Each time I talk about it, I feel like I’m honoring her memory,” Horowitz-Jackson, the Chicago woman who lost her mother, says.

And don’t forget, Mayland stresses, “Individual kindness can have an impact. It often is the small things that actually can make a difference.”

If you’re reading this, having lost someone to Covid-19, know that you are not alone. So many people are experiencing loss in the country right now, and the pain might not go away when life appears to return to normal.

For some additional resources on bereavement, check out Refuge in Grief, a website and online community with worksheets and courses for processing grief. And you can read more about therapies designed to help people with complicated grief here.

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