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Biden Picks Biotech Government to Lead New Biomedical Analysis Company

Biden Picks Biotech Executive to Lead New Biomedical Research Agency

WASHINGTON — President Biden, who outlined a vision for “bold approaches” to fighting cancer and other diseases, announced Monday that he was recruiting Dr. Renee Wegrzyn, a Boston-based biotech executive with government experience, was selected to serve as director of a new federal agency in pursuit of risky, far-reaching ideas that drive biomedical innovation.

Mr. Biden made the announcement at the John F. Kennedy Presidential Library and Museum in Boston on the 60th anniversary of the former president’s “moonshot” speech, which ushered in an era of space travel. He took the opportunity to reiterate his call to “End Cancer As We Know It” – the slogan for his own “Cancer Moonshot” initiative.

“Imagine the possibilities — vaccines that could prevent cancer, as HPV does,” the president said, referring to the human papillomavirus, which can cause cervical cancer. “Imagine molecular zip codes that could precisely deliver drugs and gene therapies to the right tissues. Imagine simple blood tests during an annual checkup that could detect cancer early.”

Mr. Biden, whose son Beau died of brain cancer in 2015, has a deep personal commitment to advancing cancer research, and the Kennedy Library was a reminder of that. Another Kennedy, former Senator Edward M. Kennedy, whom Mr. Biden described as “one of my dearest friends,” died in 2009 from the same type of cancer — glioblastoma — as Beau Biden.

Mr. Biden helped create the Cancer Moonshot when he was Vice President. His goal, which he described as “quite feasible,” is to reduce cancer death rates by at least 50 percent over the next 25 years while “converting death sentences into chronic diseases.”

With the midterm elections approaching, here stands President Biden.

He proposed the new biomedical research agency earlier this year as part of efforts to revitalize the initiative.

Modeled on the Defense Advanced Research Projects Agency, the new agency is known as the Advanced Research Projects Agency for Health. (In Washington argot, where each agency has an acronym, the Defense Research Agency is called DARPA and the Health Agency is ARPA-H.)

The agency aims to be nimble and flexible — a kind of “shark tank” for biomedical research, populated by “brilliant visionary talents” who will invest in untested approaches, knowing that “a significant proportion of projects are likely to fail,” said Dr . Francis Collins, the former director of the National Institutes of Health who now serves as Mr Biden’s acting scientific adviser and helped find the new director.

dr Wegrzyn is vice president of business development at Ginkgo Bioworks and leads innovation at Concentric by Ginkgo, the company’s initiative to promote coronavirus testing and track the spread of the virus. She also worked at DARPA and its sister agency, the Intelligence Advanced Research Projects Activity.

“Some of the problems we face every day — particularly when it comes to health and disease — are so vast that they can seem insurmountable,” said Dr. Wegrzyn in a White House statement. “I’ve seen firsthand the tremendous expertise and energy the US biomedical and biotechnology company can bring to solve some of the toughest challenges in healthcare.”

Congress has approved $1 billion for ARPA-H, which is housed at the National Institutes of Health but reports directly to Xavier Becerra, Secretary of Health and Human Services – an agreement intended to prevent the new agency too busy with the federal bureaucracy. While its director is not a Senate-approved position, Mr. Biden could be pushed back by Republicans, some of whom have argued that the agency is duplicating the NIH’s efforts.

The agency already has an acting associate director, Adam H. Russell, also a DARPA alumnus, who provided the technical infrastructure and other foundations to get the new agency off the ground. dr Collins said Dr. Wegrzyn will start work on October 1st. Her primary goal will be to hire program managers who will bring bold ideas that the agency wants to pursue, and will spend a limited time, perhaps three years, with the agency, he said.

“They’ll arrive, they’ll do a little due diligence, and then they’ll have to get the idea of ​​Dr. suggest Wegrzyn,” said Dr. Collins. “If she says ‘thumbs up,’ they’ll go off with whatever money they can spend to figure out how to put together the right partners to get the job done.”

The emergence of successful new innovations, he said, will take time. But Steve Brozak, an investment banker whose firm WBB Securities specializes in biotechnology, said if the agency is to be a success, Dr. Wegrzyn acted quickly to differentiate their work from the rest of the federal bureaucracy.

“What she needs to do is get a win on the board right away,” he said. “It doesn’t mean money. This means something that can be seen outside of the current paradigm in promoting health care for all.”

Mr. Biden’s selection was commended by Ellen V. Sigal, chair of Friends of Cancer Research, a nonprofit organization that works with industry and government to advance new therapies. Mrs. Sigal called Dr. Wegrzyn “an inspired choice,” adding that “she is a proven innovator and leader who knows science, knows how to make governments work and understands the urgency for patients across the country.”

In addition to announcing his intention to have Dr. Wegrzyn, Mr. Biden on Monday issued an executive order establishing a biotechnology and biomanufacturing initiative that aims to position the United States as a leader in the field and center drug manufacturing in the country. The coronavirus pandemic has exposed critical vulnerabilities in the supply chain for medicines and life-saving therapies.

“The United States has relied heavily on foreign materials for biomanufacturing for too long,” the White House said in a statement, “and our past outsourcing of critical industries, including biotechnology, poses a threat to our ability to access key materials such as including the active pharmaceutical ingredients for life-saving medicines.”

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Politics

SEC steps up analysis into ‘gamification’ of buying and selling with on-line brokers, Gary Gensler says

SEC steps up research into 'gamification' of trading with online brokers, Gary Gensler says

Former chairman of the Commodity Futures Trading Commission, Gary Gensler, testifies at a US Senate Banking Committee hearing on systemic risk and market oversight on Capitol Hill in Washington on May 22, 2012.

Jonathan Ernst | Reuters

The Securities and Exchange Commission announced on Friday that it is intensifying its investigation into gamification and behavioral prompts used by online brokers and investment advisors to encourage people to trade more stocks and other securities.

Wall Street’s top regulator said that rosy earnings forecasts can mislead investors from technology that in reality underestimates the risk of a particular investment or the chances of staggering returns.

“While new technologies allow us greater access and product choice, they also raise the question of whether we as investors are adequately protected when we trade and seek financial advice,” said SEC chairman Gary Gensler in a press release. “In many cases, these characteristics can encourage investors to trade more often, to invest in other products or to change their investment strategy.”

The SEC often seeks public comments before drafting new rules and regulations for Wall Street, which means Friday’s announcement, while procedural, could be a headache for industry leaders.

Robinhood Markets, the operator of a popular digital trading platform that has been under scrutiny for its client trading requests, fell as much as 1% to the day’s lows, according to the SEC report.

The commission said that online investment firms and brokers often use “predictive” analytics tools designed to show clients what they would make under optimal – but not necessarily likely – outcomes.

While brokers may disclose that their predictive models are no guarantees of future returns, Gensler would like to gather investors’ thoughts on game-like features on financial platforms, behavioral prompts, more frequent trading, and “other digital elements or features designed to interact with” retail investors on digital platforms. “

As part of the announcement, the SEC announced that it would collect public submissions for 30 days after the application and comment forms are made available online.

Gensler said he was particularly keen to hear from the public on two key issues.

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First, the SEC chairman would like to know how financial regulators should protect investors from a potential conflict of interest.

Online brokers make profits when their customers trade more often. Robinhood Markets, for example, makes part of its money by sending its customers’ orders to high-frequency traders for cash. This process is itself controversial and known on Wall Street as paying for the flow of orders.

But if game-like prompts or congratulatory messages from online brokers encourage customers to make more trades – and especially if more trades result in poor portfolio performance at slightly lower prices – should the SEC intervene?

Gensler’s second key question is a little more cerebral.

In essence, the SEC wants to answer: If the game-like or predictive prompts from brokers are producing optimal results and affecting how often clients trade, should the regulator treat those prompts in the app as formal investment recommendations or advice?

The SEC often seeks public comments before drafting new rules and regulations for Wall Street, which means Friday’s announcement, while procedural, could be a headache for industry leaders.

Despite the stellar growth of the millennials favorite stock trading app, Robinhood has faced regulatory headwinds when it comes to its digital engagement with its millions of clients.

The financial industry regulator imposed Robinhood in June with the highest fine ever of around $ 70 million. FINRA said its penalty came in response to Robinhood’s technical failures in March during a spike in trading frenzy, their lack of diligence in authorizing clients to place option trades, and providing misleading information to clients on issues such as margin trading .

CEO Vlad Tenev testified to the U.S. House of Representatives Financial Services Committee in February about the GameStop trading mania in early 2021.

Robinhood also paid the SEC $ 65 million after being charged with misleading clients about how the app makes money and fails to deliver the promised best execution of trades.

In response to the public backlash, Robinhood has since taken steps to address some of the controls, such as:

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BioBonds Use Wall Road Instruments to Fund Medical Analysis

BioBonds Use Wall Street Tools to Fund Medical Research

In disease treatment development, the phase between basic research and advanced clinical trials is referred to as the “valley of death”.

While early-stage research is abundantly funded with public grants and pharmaceutical companies are willing to fund trials of proven solutions, research in the “translational” stage, where basic knowledge is applied to potential treatments, is notoriously difficult to fund. As a result, some promising treatments are never pursued.

The pandemic has made this dangerous valley “much deeper,” said Karen Petrou, co-founder and managing partner of Federal Financial Analytics, a Washington financial services advisory firm that has developed a new financial tool designed to help solve this problem.

During the pandemic, clinical trials were halted, resources withdrawn from laboratories, attention turned to immediate needs, and many resources dried up. New research projects were difficult to start.

At the same time, the value of funding scientific research became even clearer: without the initial efforts of academic laboratories, it would have been impossible for large pharmaceutical companies to accelerate vaccine development.

The solution proposed by Ms. Petrou, known as BioBonds, gained in importance.

The program would create low-interest, government-sponsored loans for translational research. Similar to mortgages, these would be wrapped in a bond and sold on the secondary market to risk-averse institutional investors such as pension funds.

In May, Rep. Bobby Rush, Democrat from Illinois, and Rep. Brian Fitzpatrick, Republican from Pennsylvania introduced a bill that, if passed, would create these $ 30 billion worth of three-year loans.

Ms. Petrou, who was diagnosed with retinal degeneration as a teenager and went blind in her 40s, first stumbled upon the “Valley of Death” in 2013. She raised money for studies to expedite retinal degeneration treatment, but potential investors said your translational projects were too speculative – they needed results that show a potential idea works, preferably with a large population dependent on pills.

She refused to take this as a definitive answer. Many countries support private sector funding for biomedical research, and each does it differently, Ms. Petrou said, “We needed an American model.”

Ms. Petrou and her husband Basil have advised Wall Street executives and regulators for decades. (She recently wrote a book on monetary policy that promotes inequality.) You had thought a lot about mixed public-private markets during the mortgage finance crisis. Inspired by green bonds – publicly secured loans that have created a $ 750 billion private market for sustainability projects since 2007 – they started work on the idea that became BioBonds.

“It’s a lifeline,” said Attila Seyhan, director of translational oncology at Brown University and a former Pfizer scientist, of the idea. He said his colleagues were equally intrigued.

Unlike grants, the researchers would have to repay BioBonds loans. Still, it is a “constant struggle,” said Dr. Seyhan, getting full funding, and “there is tremendous frustration with the lack of alternatives.”

He believes that university divisions are getting “creative” to make BioBonds work. “There will be losses,” he said. “But if 1 percent is successful, you pay off the losses. This is how drug development works. “

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Many schools are already encouraging scholars to find funding outside of grants to pursue their ideas. Scientists are increasingly saying that they need to think like venture capitalists and keep commercialization in mind when designing clinical trials so they can raise money from private companies to fund them.

“Even if we discover something, universities have to help researchers make the transition to commercialization,” says Dr. Richard Burkhart, surgeon and researcher at Johns Hopkins University School of Medicine. His work is currently funded by the National Institutes of Health, but he is working with his institution’s Technology Ventures team to commercialize his work.

While grants are preferable, they are not abundant. Dr. Burkhart believes BioBonds can help scientists and institutions navigate difficult translational space.

When Petrous first developed the BioBond concept, they proposed a modest pilot program to study blindness. The law was introduced in the 2018 session in the House of Representatives and in a new session in 2019. Then everything changed. “Covid hit and US biomedicine just stopped,” Ms. Petrou recalled.

Meanwhile, the couple’s understanding of the need for more translational research tragically developed. Mr. Petrou was diagnosed with pancreatic cancer in 2018. After an operation in 2019 as part of a clinical study by Dr. Burkhart, Mr. Petrou was considered cancer-free. But in April last year, a routine check-up showed the disease had come back.

The Petrous were determined to find another trial, but thousands of them were stopped because of the pandemic. They were stuck in lockdown at home and decided to rethink their BioBonds idea but think bigger. They repurposed and expanded their initial proposal to relieve the added stress on the already ailing translational space.

“When we started hearing about the havoc in the context of clinical trials, I was quick to turn around,” said Valerie White, a recently retired financial services lobbyist, formerly with Akin Gump. She had helped develop the original bond concept and immediately began talking to contacts in Congress about BioBonds.

Legislation introduced by Mr. Rush and Mr. Fitzpatrick in May called the Long-term Opportunities for Advancing New Studies for Biomedical Research Act, or LOANS for Biomedical Research, would require the Secretary of Health to guarantee US $ 10 billion a year for three years to fund loans to universities and other laboratories to conduct FDA-approved clinical trials. The bill is supported by 14 co-sponsors and about 20 organizations, including the Alliance for Aging Research, Alzheimer’s Drug Discovery Association, Blinded Veterans Association, and the Juvenile Diabetes Research Foundation.

“This should, quite frankly, attract the attention of many different sectors in Congress,” said Ms. White. In their view, more biomedical research will not only save lives, but also lead to increased military readiness and profitability, among other things.

She volunteered for the project for four years and said she would continue until the BioBonds Act goes into effect.

Mr Petrou will not be there to celebrate when that day comes. He died in March. Ms. Petrou believes the surgery he underwent as part of the clinical trial would have saved his life had it not been for other complications.

Ms. Petrou is determined to see the LOANS Act passed to pay tribute to her partner for more than a quarter of a century. She thinks a lot about all the pain people are going through now, fear that could be avoided in the future if more work was done on all kinds of remedies, including cancer and blindness.

“That was their baby from the start,” said Ms. White, who was present at the couple’s wedding and remained friends with them over the years. “It’s almost ironic that this whole project started with eye contacts that could have helped Karen, but in the end Basil could have benefited if that idea had existed before.”

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Social Isolation in U.S. Rose as Covid Disaster Started to Subside, Analysis Exhibits

Social Isolation in U.S. Rose as Covid Crisis Began to Subside, Research Shows

Many Americans felt socially isolated during the pandemic, cut off from friends and family while crouching and keeping their distance to protect themselves from infection.

However, new research released Thursday suggests that even as the United States’ public health crisis subsided, communities opened up, and the economy improved, many people’s feelings of isolation have increased.

While the level of social isolation decreased in the spring of the pandemic after the initial shock of the crisis subsided, according to researchers from Harvard, Northeastern, Northwestern and Rutgers universities, it increased sharply in the summer months of last year before turning during the year autumn leveled off again.

People began to feel less disconnected from December to April this year, but the levels of social isolation measured by the researchers increased again this June.

The results suggest that recovery from the pandemic could take a long time and could affect people’s view of their relationships over time. “There were cumulative effects of social isolation,” said David Lazer, professor of political science and computer science at Northeastern and one of the study authors.

To determine social isolation, the researchers asked each person how many people they could count on to care for them when they were sick, to lend them money, to talk to them about a problem when they were depressed, or to help them with the Searching for a job. Someone who said they had only one person or no one to turn to in a certain category was considered socially isolated.

The researchers interviewed a total of 185,223 people in 12 different surveys from April 2020 to June 2021.

Even now, with many more people vaccinated against the coronavirus and becoming much more active in their communities, people may think differently about those they previously relied on. “This break in life can lead to a lot of overwork in our relationships,” said Dr. Lazer, who pointed out the unusual number of people who decided to leave their jobs when the pandemic ends. “It takes a while for the social fabric to heal.”

The increase in the feeling of isolation even when the most severe restrictions were lifted was “noticeable,” said Mario L. Small, a professor of sociology at Harvard University who was not involved in the study. People may have felt they had fewer people to lean on because they physically distanced themselves from a wide network of acquaintances and friends, he said, even as the locks eased.

The researchers found that last summer, despite seeing more people, people’s isolation increased. “Our results show that it is difficult to recover from social isolation and is not just due to increased social contact,” the researchers concluded.

The researchers also point to a strong association between social isolation, particularly among people who said they lacked people to turn to for emotional support, and moderate or severe depression.

Many of the lower-income and less-educated people hardest hit by the pandemic appear to be improving more slowly, said Dr. Lazer. “We are definitely seeing a segregation of fates in terms of socioeconomic status,” he said, with some groups experiencing longer and more uneven recovery.

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Home Passes Payments to Bolster Scientific Analysis, Breaking With Senate

House Passes Bills to Bolster Scientific Research, Breaking With Senate

WASHINGTON — The House on Monday passed two bipartisan bills aimed at bolstering research and development programs in the United States, setting up a battle with the Senate over how best to invest in scientific innovation to strengthen American competitiveness.

The bills are the House’s answer to the sprawling Endless Frontier Act that the Senate overwhelmingly passed this month, which would sink unprecedented federal investments into a slew of emerging technologies in a bid to compete with China. But lawmakers who drafted the House measures took a different approach, calling for a doubling of funding over the next five years for traditional research initiatives at the National Science Foundation and a 7 percent increase for the Energy Department’s Office of Science.

The contrast reflected concerns among House lawmakers that the Senate bill placed an outsize and overly prescriptive focus on developing nascent technologies and on replicating Beijing’s aggressive moves to gain industrial dominance. Instead, the lawmakers argued, the United States should pour more resources into its own proven research and development abilities.

“If we are to remain the world leader in science and technology, we need to act now,” said Representative Eddie Bernice Johnson, Democrat of Texas and the chairwoman of the Science Committee. “But we shouldn’t act rashly. Instead of trying to copy the efforts of our emerging competitors, we should be doubling down on the proven innovation engines we have at the National Science Foundation and the Department of Energy.”

Lawmakers and their aides must try to reconcile the Senate-passed legislation with the two bills passed on Monday, prompting a major debate on Capitol Hill about industrial policy and how to strengthen American competitiveness, a goal with broad bipartisan support.

The two bills passed 345-67 and 351-68.

“One of the core disagreements or tensions between the House and the Senate version is that the Senate version is really focused on China,” said Robert D. Atkinson, the president of the Information Technology and Innovation Foundation. Ms. Johnson’s bills, he added, prioritize “more social policy issues,” including science, technology, engineering and mathematics education and climate change.

The House bills omit a number of provisions that are centerpieces of the Senate legislation, including $52 billion in emergency subsidies for semiconductor makers and a slew of trade provisions. Instead of creating regional technology hubs across the country, as the Senate measure would do, one of the House bills would establish a designated directorate for “science and engineering solutions” in the National Science Foundation.

While singling out several emerging technologies, including artificial intelligence and advanced computing, lawmakers on the House Science Committee have mostly focused on research and funding a holistic approach to scientific innovation.

“History teaches that problem-solving can itself drive the innovation that in turn spawns new industries and achieves competitive advantage,” Ms. Johnson wrote.

William A. Reinsch, the Scholl chair in international business at the Center for Strategic and International Studies, said with sections on public health challenges and the STEM work force, the House had taken “a broader definition of how to get our innovation capabilities up and running.”

The Senate legislation, passed by a vote of 68-32, was steered through the chamber by Senator Chuck Schumer, Democrat of New York and the majority leader, a longtime China hawk who has been eager to enact what would be the most significant government intervention in industrial policy in decades. It was powered in large part by bipartisan concern about China’s chokehold on global supply chains, which has grown particularly acute amid shortages brought on by the coronavirus pandemic. President Biden applauded its passage and said that he hoped to sign it into law “as soon as possible.”

It would allocate hundreds of billions more into scientific research and development pipelines in the United States, create grants, and foster agreements between private companies and research universities to encourage breakthroughs in new technology.

As the legislation moved through the chamber, echoing similar concerns from lawmakers on the House Science Committee, senators shifted much of the $100 billion that had been slated for a research and development hub for emerging technologies at the National Science Foundation to basic research, as well as laboratories run by the Energy Department. The amount for cutting-edge research was reduced to $29 billion, with the rest of the original funds funneled toward research and labs.

Those changes may assuage House lawmakers as they seek to reconcile the two bills in the coming months.

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Covid Lab-Leak Idea Renews ‘Achieve-of-Perform’ Analysis Debate

Covid Lab-Leak Theory Renews "Gain-of-Function" Research Debate

In the United States, “there are no biosafety rules or regulations that have the force of law,” he said. “And this is in contrast to every other aspect of biomedical research.” There are enforceable rules, for example, for experiments with human subjects, vertebrate animals, radioactive materials and lasers, but none for research with disease-causing organisms.

Dr. Relman, who also supports the need for independent regulation, cautioned that legal restrictions, as opposed to guidelines or more flexible regulations, could also pose problems. “The law is cumbersome and slow,” he said. At one point in the evolution of laws relating to biological warfare, for example, Congress prohibited the possession of smallpox. But the rule’s language, Dr. Relman said, also seemed to ban possession of the vaccine because of its genetic similarity to the virus itself. “To try to fix it took forever,” he said.

The current H.H.S. policy also doesn’t offer much guidance about working with scientists in other countries. Some have different policies about gain-of-function research, while others have none at all.

Dr. Gronvall of Johns Hopkins argued that the U.S. government cannot dictate what scientists do in other parts of the world. “You have to embrace self-governance,” she said. “You’re not able to sit on everyone’s shoulder.”

Even if other countries fall short on gain-of-function research policies, Dr. Lipsitch said that shouldn’t stop the United States from developing better ones. As the world’s leader in biomedical research, the country could set an example. “The United States is sufficiently central,” Dr. Lipsitch said. “What we do really does matter.”

Ironically, the pandemic put deliberations over such issues on hold. But there’s no question the coronavirus will influence the shape of the debate. Jesse Bloom, a virologist at the Fred Hutchinson Cancer Research Center, said that before the pandemic, the idea of a new virus sweeping the world and causing millions of deaths felt hypothetically plausible. Now he has seen what such a virus can do.

“You have to think really carefully about any kind of research that could lead to that sort of mishap in the future,” Dr. Bloom said.

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Covid Lab-Leak Principle Renews “Achieve-of-Operate” Analysis Debate

Covid Lab-Leak Theory Renews "Gain-of-Function" Research Debate

In the United States, “there are no biosafety rules or regulations that have the force of law,” he said. “And this is in contrast to every other aspect of biomedical research.” There are enforceable rules, for example, for experiments with human subjects, vertebrate animals, radioactive materials and lasers, but none for research with disease-causing organisms.

Dr. Relman, who also supports the need for independent regulation, cautioned that legal restrictions, as opposed to guidelines or more flexible regulations, could also pose problems. “The law is cumbersome and slow,” he said. At one point in the evolution of laws relating to biological warfare, for example, Congress prohibited the possession of smallpox. But the rule’s language, Dr. Relman said, also seemed to ban possession of the vaccine because of its genetic similarity to the virus itself. “To try to fix it took forever,” he said.

The current H.H.S. policy also doesn’t offer much guidance about working with scientists in other countries. Some have different policies about gain-of-function research, while others have none at all.

Dr. Gronvall of Johns Hopkins argued that the U.S. government cannot dictate what scientists do in other parts of the world. “You have to embrace self-governance,” she said. “You’re not able to sit on everyone’s shoulder.”

Even if other countries fall short on gain-of-function research policies, Dr. Lipsitch said that shouldn’t stop the United States from developing better ones. As the world’s leader in biomedical research, the country could set an example. “The United States is sufficiently central,” Dr. Lipsitch said. “What we do really does matter.”

Ironically, the pandemic put deliberations over such issues on hold. But there’s no question the coronavirus will influence the shape of the debate. Jesse Bloom, a virologist at the Fred Hutchinson Cancer Research Center, said that before the pandemic, the idea of a new virus sweeping the world and causing millions of deaths felt hypothetically plausible. Now he has seen what such a virus can do.

“You have to think really carefully about any kind of research that could lead to that sort of mishap in the future,” Dr. Bloom said.

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Health

No Being pregnant Danger Discovered From 2 Covid-19 Vaccines, Preliminary Analysis Exhibits

No Pregnancy Risk Found From 2 Covid-19 Vaccines, Preliminary Research Shows

In an early analysis of coronavirus vaccine safety data, researchers from the Centers for Disease Control and Prevention found no evidence that the Pfizer-BioNTech or Moderna vaccines posed a serious risk during pregnancy.

The results are preliminary and only cover the first 11 weeks of the US vaccination program. The study, which included self-reported data on more than 35,000 people who received any of the vaccines during or shortly before pregnancy, is the largest to date on the safety of coronavirus vaccines in pregnant women.

Pregnant women were excluded during clinical trials with the vaccines. Patients, doctors and experts were therefore unsure whether the shots could be safely administered during pregnancy.

“There is great concern about whether it is safe and whether it would work and what to expect in terms of side effects,” said Dr. Stephanie Gaw, a Maternal-Fetal Medicine Specialist at the University of California at San Francisco.

The new data, said Dr. Gaw, show that “many pregnant people receive the vaccine, there is no significant increase in adverse pregnancy effects at this point and that the side effect profiles are not very similar to pregnant people.”

“I think this is all very comforting,” she said, “and I think it will really help public health providers and officials recommend the vaccine more strongly during pregnancy.”

Covid-19 carries serious risks during pregnancy. Pregnant women who develop symptoms of the disease are more likely to become seriously ill and die more often than non-pregnant women with symptoms.

Because of these risks, the CDC has recommended providing coronavirus vaccines to pregnant women, but also suggests that they consult their doctor when deciding whether to vaccinate.

The new study, published Wednesday in the New England Journal of Medicine, is largely based on self-reported data from V-safe, the CDC’s coronavirus vaccine safety monitoring system. Participants in the program use a smartphone app to regularly conduct surveys about their health and possible side effects after receiving a Covid-19 vaccine.

The researchers analyzed the side effects of V-Safe participants who received either the Pfizer or Moderna vaccine between December 14, 2020 and February 28, 2021. They focused on 35,691 participants who said they were pregnant when they received the vaccine or became pregnant shortly afterwards.

After vaccination, pregnant participants reported the same general pattern of side effects as non-pregnant women, the researchers noted: injection site pain, fatigue, headache, and muscle pain.

What You Need To Know About The Johnson & Johnson Vaccine Break In The United States

    • On April 13, 2021, U.S. health officials called for an immediate halt to use of Johnson & Johnson’s single-dose Covid-19 vaccine after six recipients in the U.S. developed a rare blood clot disorder within one to three weeks of being vaccinated.
    • All 50 states, Washington, DC, and Puerto Rico have temporarily stopped using the vaccine or recommended providers are suspending use of the vaccine. The U.S. military, government-run vaccination centers, and a variety of private companies, including CVS, Walgreens, Rite Aid, Walmart, and Publix, also paused the injections.
    • Fewer than one in a million Johnson & Johnson vaccinations are currently being studied. If there is indeed a risk of blood clots from the vaccine – which has yet to be determined – the risk is extremely small. The risk of contracting Covid-19 in the United States is much higher.
    • The hiatus could complicate the country’s vaccination efforts at a time when many states are facing spikes in new cases and are trying to address vaccine hesitation.
    • Johnson & Johnson had also decided to delay the launch of its vaccine in Europe amid concerns about rare blood clots. However, the company later decided to continue its campaign after the European Union Medicines Agency announced the addition of a warning. South Africa, devastated by a contagious variant of the virus, stopped using the vaccine and Australia announced it would not buy doses.

Pregnant women were slightly more likely to report injection site pain than women who did not, but were less likely to report the other side effects. They were also slightly more likely to report nausea or vomiting after the second dose.

Pregnant V-safe participants also had the option of enrolling in a special register that recorded pregnancy and infant results.

By the end of February, 827 of the people on the pregnancy register had completed their pregnancies, of which 86 percent resulted in a live birth. The incidence of miscarriages, premature births, low birth weight, and birth defects were consistent with those reported in pregnant women prior to the pandemic, the researchers report.

“This study is critical for pregnant people,” said Dr. Michal Elovitz, a maternal-fetal medicine specialist at the University of Pennsylvania, in an email. “It’s very comforting that no acute events have been reported in pregnant people,” she said as the study progressed.

However, the report has several caveats, and experts say a lot more research is needed. Participation in the monitoring programs is voluntary and the data is reported by yourself.

Since the study period only spanned the first few months of the US vaccination campaign, the vast majority of those on the pregnancy registry were healthcare workers. And there is still no data on pregnancy outcomes for people vaccinated in the first trimester of pregnancy.

“I think we can feel more secure if we recommend the vaccine during pregnancy, especially in pregnant people who are at risk of Covid,” said Dr. Gaw. “But we do I will have to wait for more data to get full pregnancy results from early pregnancy vaccines. “

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Biden Administration Ends Restrict on Fetal Tissue Analysis

Biden Administration Ends Limit on Fetal Tissue Research

The Biden administration on Friday lifted restrictions on the use of fetal tissue for medical research and lifted the rules imposed by President Donald J. Trump in 2019.

The new rules, published by the National Institutes of Health, allow scientists to use tissues from elective abortions to study and develop treatments for diseases such as diabetes, cancer, AIDS, and Covid-19.

The Department of Health and Human Services, which oversees the NIH, has essentially restored guidelines in place during the Obama administration. The NIH will “manage and monitor research involving human fetal tissue in accordance with applicable policies and procedures,” ahead of the June 2019 ban, the agency said in a statement emailed Saturday. The development was first reported on Friday by the Washington Post.

Scientists can buy fetal tissue from sources approved prior to the ban, and any projects approved prior to Trump administration restrictions will be “resumed without further review,” according to an email sent to scientists by the NIH recorded “

“This is fantastic,” said Dr. Mike McCune, HIV expert at the Bill & Melinda Gates Foundation and Professor Emeritus at the University of California at San Francisco. However, he cautioned that it could take some time for the research to recover.

Working with fetal tissue is a specialty and many of the scientists with that expertise have left the field, he said. “People with decades of experience had to find other jobs,” he said. “All of that has to be restored in order for it to start again – but they will.”

The lifting of the ban fulfilled a promise by the Biden government to support science and dismayed conservative groups who oppose research on fetal tissue as a violation of the sanctity of life.

“HHS’s decision to resume experimentation on body parts of aborted children is contrary to both best ethics and most promising science,” said Tara Sander Lee, senior fellow and director of life sciences at the Charlotte Lozier Institute, in a statement.

“The exploitation of the bodies of these young people is unnecessary and grotesque,” she said. “There are superior and ethical alternatives.”

Human cells taken years ago from a fetus were used to develop the monoclonal antibody treatments given to Mr. Trump following his diagnosis of Covid-19 in October. Many of the coronavirus vaccines funded by Operation Warp Speed ​​have also been tested in cells derived from fetal tissue.

Some scholars criticized what they viewed as double standards, saying Mr Trump should not have taken treatment that was developed on the basis of research he had banned.

“It was just so hypocritical,” said Lawrence Goldstein, a neuroscientist at the University of California at San Diego who used fetal tissue in his research.

Dr. Goldstein said he hoped a future Republican administration would not reinstate Mr Trump’s ban. “It would be terrible for this research to be on a yo-yo,” he said. “It will die when that happens.”

Updated

April 17, 2021, 6:20 p.m. ET

Some conservative and religious organizations have suggested that scientists use tissues from spontaneous rather than elective abortions. However, spontaneous abortions often result from genetic and developmental disorders that would render the fetal tissue unusable for research.

Scientists have been using fetal tissue to create cell lines for life-saving research into vaccines and treatments for many diseases for decades. Since the 1980s, so-called humanized mice, which contain fetal human tissue or organs, have served as the linchpin for developing treatments and studying the immune response to pathogens such as the coronavirus.

Many drugs that had worked spectacularly well in normal mice failed in human clinical trials, noted Dr. Goldstein firmly. “Mice are not just tiny people, so mice with a humanized immune system are very valuable.”

Fetal tissue is also used to study how human organs and systems develop in the uterus. “It’s the biology of young people; How do you do that by studying old people? “Dr. McCune said. “It just doesn’t work.”

In June 2019, the Trump administration abruptly cut funding for government laboratory projects based on fetal tissue. The NIH also urged academic scientists seeking federal funding to fully substantiate their need for human fetal tissue and set up an ethics committee to review these suggestions.

What You Need To Know About The Johnson & Johnson Vaccine Break In The United States

    • On April 13, 2021, U.S. health officials called for an immediate halt to use of Johnson & Johnson’s single-dose Covid-19 vaccine after six recipients in the U.S. developed a rare blood clot disorder within one to three weeks of vaccination.
    • All 50 states, Washington, DC, and Puerto Rico have temporarily suspended use of the vaccine or suspended from recommended vendors. The U.S. military, government-run vaccination centers, and a variety of private companies, including CVS, Walgreens, Rite Aid, Walmart, and Publix, also paused the injections.
    • Fewer than one in a million Johnson & Johnson vaccinations are currently being studied. If there is indeed a risk of blood clots from the vaccine – which has yet to be determined – the risk is extremely small. The risk of contracting Covid-19 in the United States is much higher.
    • The hiatus could complicate the country’s vaccination efforts at a time when many states are facing spikes in new cases and are trying to address vaccine hesitation.
    • Johnson & Johnson has also decided to delay the launch of its vaccine in Europe amid concerns about rare blood clots, which is taking another blow to the vaccine surge in Europe. South Africa, devastated by a contagious variant of the virus found there, also stopped using the vaccine. Australia announced that it would not buy cans.

HHS said in a statement at the time, “Promoting the dignity of human life from conception to natural death is a top priority for President Trump’s administration.”

However, the restrictions were a ban that held projects up and in some cases wasted years of effort. For example, the ban stopped research that had increased the median survival of women with metastatic breast cancer from two to ten years in a small study, said Dr. Irving Weissman, a Stanford University cancer expert who led the study.

In July, 90 scientific, medical and patient organizations signed a letter calling on the ethics committee to allow the use of fetal tissue to develop treatments for Covid-19 and other diseases.

“Fetal tissue has unique and valuable properties that often cannot be replaced by other cell types,” the statement said.

In August, however, the board rejected all but one of 14 proposals. The only proposal approved was based on previously acquired fetal tissue.

The following month, the House Committee on Oversight and Reform reported that the Trump administration’s ban was “based on ideological objections, not an assessment of the scientific merit of such projects.”

The NIH’s announcement of the new rules came a day after Xavier Becerra, secretary for health and human services, stated at a budget hearing on Capitol Hill that the agency would change the rules for research on fetal tissue. Mr Becerra did not reveal any details, but his testimony and the general acceptance of science by the Biden administration suggested that Trump-era restrictions would be reversed.

“We believe we need to do the research that is needed to make sure we are innovating and bringing all of these types of treatments and therapies to the American people,” Becerra said at the hearing.

The NIH said in its statement on Saturday that it would not set up another ethics committee “because the HHS secretary has determined that there are no new ethical issues that need special review.”

Scientists must follow other rules for research, including obtaining informed consent from the tissue donor. They can’t pay donors to get the tissue or benefit from studies, the agency said, but they are otherwise free to resume the research.

“These ethical safeguards and oversights are enough to prevent anything most people would say from being outrageous,” said Dr. Weissman. “This is a welcome change.”

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Health

Can Covid Analysis Assist Resolve the Mysteries of Different Viruses?

Can Covid Research Help Solve the Mysteries of Other Viruses?

However, symptoms such as fatigue are often not recognized as being associated with myocarditis. And Dr. McManus suspects that the fatigue that sometimes follows a battle with Covid-19 could be caused by this heart problem.

“We view Covid-19 and influenza as respiratory diseases, and indeed they are,” said Dr. Bruce M. McManus, Professor Emeritus of Pathology at the University of British Columbia. “But the reason many patients die in many cases is because of the myocardium.”

Some seriously ill Covid patients have lung damage. That can also happen with other viruses, said Dr. Clemente Britto-Leon, lung researcher at the Yale School of Medicine. He lists a few possibilities.

“You can have lung injuries and scars with influenza, herpes viruses, and cytomegalovirus infections,” said Dr. Britto and was referring to a common virus that usually doesn’t cause symptoms. All of these viruses can, on rare occasions, cause harm, he said. “You can have a very serious injury and a lot of tissue damage.”

Influenza can cause blood clots in the lining of the lungs that look just like the small blood clots in the lungs of some Covid patients, said Marco Goeijenbier of Erasmus University in the Netherlands. It happens when flu viruses infect the lower respiratory tract, an unusual occurrence since most people already have protective immunity.

Dr. Goeijenbier wants to examine the blood clots that occur in these cases. So far, he and others have reproduced and examined the effects in so few patients in laboratory studies and in ferrets – the animals of choice for studying the flu.

“It was hard to get money,” he said. “Big magazines or funders didn’t find it interesting enough,” he said.

Covid changes that.

There is now “a huge cohort of people to study,” said Pamela Dalton, a olfactory researcher at Monell. But “the big question is, even if you learn all about SARS-CoV-2” – the formal name of the coronavirus – “how generalizable is it?”