European regulators are investigating whether Johnson & Johnson’s COVID-19 vaccine caused unusual blood clotting after four cases were reported in vaccine recipients, including one fatality.
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee disclosed Friday that they are reviewing the vaccine after three people who received J&J’s vaccine in the US and another who was involved in a clinical trial developed blood clots. It’s currently not clear if the vaccine caused these clots.
J&J said that it was working closely with experts and regulators to assess data coming in, but that so far, they have found a small number of very rare side effects.
The investigation comes as European states prepare to add the vaccine to their roster of COVID-19 shots. J&J’s vaccine was recommended for authorization by the EMA on March 11, but has not yet been distributed.
The agency stated Wednesday that blood clots can be a “very rare” side effect of AstraZeneca’s shot in people with low blood platelet levels. Approximately 169 cases of blood clots in the brain and 53 cases of blood clots in the spleen had been reported as of April 4, according to the EMA.
Issues have been popping up as J&J’s shot has rolled out in the US.
One of the factories that produces both drug companies’ vaccines is in hot water after it was reported by the New York Times that 15 million doses of Johnson & Johnson’s vaccine had been cross-contaminated with AstraZeneca’s vaccine at a U.S. factory run by Emergent BioSolutions. None of those shots were distributed to the public.
Officials in Colorado and North Carolina stopped giving out J&J’s vaccine this week after two dozen people experienced minor adverse reactions like nausea and dizziness.
J&J’s stock traded down about 1% on Friday morning.
Dr. Ashish Jha, a top US public-health expert, earlier this month laid out what he thought was an unpopular opinion.
Shortly after AstraZeneca announced that its coronavirus vaccine was found to be safe and effective in a 32,000-volunteer US trial, Jha argued that the US should donate its supply of the shot to other countries, rather than reserve it for use domestically.
“The time to use AZ here would have been in January,” he wrote on Twitter. “By May, we won’t need it.”
Now, Jha’s unpopular opinionhas gained momentum, even as experts anticipate the vaccine will soon secure US emergency authorization.
There are two main reasons the vaccine experts said the shot from AstraZeneca and Oxford University won’t be used much in the US, if at all. For one, it’s likely to be authorized after most US adults have gotten a vaccine made by another company. And there isn’t a good argument to be made that it’s at least as good as the three shots already in use in this country.
“If there is a choice and if we have enough doses of the other three vaccines, then the argument for incorporating AstraZeneca is slim to none in US vaccine distribution,” Josh Michaud, associate director of global health policy at the nonprofit Kaiser Family Foundation, told Insider.
US government leaders haven’t said what they plan to do if AstraZeneca’s shot is authorized, but appear to be considering not rolling out the shot.
“That’s still up in the air,” Dr. Anthony Fauci, the nation’s top infectious-disease expert, told Reuters on April 1. “My general feeling is that given the contractual relationships that we have with a number of companies, that we have enough vaccine to fulfill all of our needs without invoking AstraZeneca.”
The vaccine still has a critical role to play on the world stage. It’s one of the only vaccines, alongside shots developed in Russia and China, where substantial amounts have been delivered to low- and middle-income countries, said Maria Elena Bottazzi, a vaccine developer and associate dean of Baylor University’s National School of Tropical Medicine. From the start, AstraZeneca has sold its shot at no-profit pricing at $3 to $4 per dose – far cheaper than other vaccine developers.
That leaves the US in a curious position, because the government signed a deal with AstraZeneca last summer to eventually deliver 300 million doses of the shot.
Bottazzi said the US should donate those doses to Covax, the World Health Organization’s vaccine procurement effort for lower-income countries.
A history of controversies and late-to-market timing don’t help chances in the US
Experts highlighted two challenges impeding AstraZeneca’s US rollout: a lagging timeline and a bungled public rollout rife with controversies over its safety and efficacy.
Three experts Insider spoke with recently – Michaud, Bottazzi, and Fred Hutchinson’s Dr. Larry Corey -agreed the vaccine is likely to win an emergency use authorization (EUA) from the US Food and Drug Administration. Andrew Berens, an industry analyst at SVB Leerink covering AstraZeneca, also recently told investors that the shot is likely to win US authorization.
The vaccine meets standards that FDA set last summer for experimental COVID-19 vaccines. In late-March, AstraZeneca announced success in a US-funded study, saying the vaccine was 76% effective at preventing symptomatic cases of COVID-19, and 100% effective at stopping hospitalizations and deaths. The study also found the shot was safe.
“From the data that we can see, it’s a very good vaccine and doesn’t raise any real red flags,” Michaud said. “It would seem to be on a path to authorization.”
If this was the first vaccine to produce late-stage results, that would have been seen as a phenomenal result. But vaccines from Moderna and from Pfizer demonstrated efficacy level of about 95%.
J&J’s vaccine was less effective at preventing symptomatic illness. But that shot, too, has a unique case for being used. It’s a one-dose vaccine with much milder side effects than Moderna’s and Pfizer’s. AstraZeneca’s shot is given as two doses several weeks apart, as are vaccines from Moderna and Pfizer.
Also J&J’s trial tested the shot in South Africa and Latin America at times when concerning virus variants had taken over, and showed the vaccine is still effective against these different strains.
Beyond that, AstraZeneca’s vaccine has also suffered from a confusing and chaotic rollout. Some of the mistakes have been self-inflicted by AstraZeneca and Oxford, while others were out of its control. The latest controversy is over concerns that the vaccine could cause blood clots, particularly in younger women. While European regulators have said they have not found evidence of any link, some countries temporarily suspended the shot’s rollout or limited its use in younger people.
Even with rollout in doubt, US authorization alone would hold value
A company spokesperson said that AstraZeneca plans to file with the US FDA for an emergency use authorization in the first half of April.
While FDA reviews of new medicines typically take at least half a year, the currently authorized COVID-19 vaccines have been reviewed in record time. Still, those evaluations require at least several weeks – meaning an EUA likely will come in May, at the earliest.
While experts aren’t convinced the shot has a significant role to play in the US rollout, an FDA OK would still be helpful by boosting public confidence in the shot around the world, Bottazzi said.
If the US doesn’t roll out the AstraZeneca vaccine domestically, it could to donate its doses. That could come either by direct, country-to-country donations, or through Covax, the WHO’s vaccine equity program. Already, the US has given 4 million doses to Canada and Mexico.
AstraZeneca’s shot would be a “very good candidate to donate to Covax,” Kaiser’s Michaud said.
“It would seem like that would be a good use for it, given that we do meet the needs of Americans with other vaccines that we have available,” he said.
The European regulator said on Wednesday that there was “no evidence” to restrict the use of the COVID-19 vaccine made by AstraZeneca and Oxford University in “any population.”
Countries including Canada, Germany, France, and Italy have put the shot on hold for younger people as a precaution while regulators investigate reports of unusual blood clots, particularly in younger women.
“The benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalization and death, outweigh the risks of side effects,” the European Medicines Agency said in a press briefing Wednesday. It’s a view that’s consistent with what the regulator has said in recent weeks.
The EMA said that an expert panel – including hematologists, neurologists and epidemiologists – had not been able to identify any specific risk factors including age, gender, or previous medical disorder that predisposed people to “these very rare events.”
Emer Cooke, EMA’s executive director, said that a “causal link” between rare blood disorders and AstraZeneca’s vaccine was not proven, but it was “possible” and analysis was ongoing.
The EMA will aim to reach a “scientific conclusion next week,” she said.
Cooke said that the EMA provides information that countries need to make decisions about vaccine rollouts, but national vaccine campaigns differ according to need – the number of infections, vaccine availability and pressure on hospitals, for example.
Determining whether there’s a link between blood clots and AstraZeneca’s shot
There had been 62 cases worldwide of a rare blood clot in the brain, reported to the EMA and 9.2 million people had been vaccinated with AstraZeneca’s shot as of March 22, which amounted to 1 case in 100,000, the regulator said.
The EMA said that the blood clot in the brain called central venous sinus thrombosis (CVST) were reported mostly in women under 60 years old. But it was difficult to “disentangle” whether the vaccine was causing the clots or not. CVST can occur without the presence of vaccines. It’s more likely to occur to women aged between 30 to 45, and it’s more likely to occur in women than men, the agency said.
The regulator also acknowledged that the relatively high number of young women who reported CVST could be related to the vaccine’s rollout – young healthcare workers were one of the early priority groups, and this group includes a high proportion of women. And when the shot was first authorized in the EU, Germany, France, and Italy did not give the shot to people over 65, so more younger people could have received AstraZeneca’s shot.
There have been a number of theories discussed in the scientific community around the blood clots. For example, Canadian officials on Monday referred to a phenomenon called Vaccine-Induced Prothrombotic Immune Thrombocytopenia. In this disorder, antibodies “activate” platelets and cause blood clots to form, the National Advisory Committee on Immunization said.
The EMA said that it at looked at these theories but they weren’t proven.
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There’s still a flurry of questions surrounding vaccines for pregnant people. Insider is hosting a Q&A with OB-GYN Dr. Jessica Shepard and pediatrician Dr. Jessica Madden this afternoon – You can register for the event here.
Even drug giant AstraZeneca was put under the microscope this week, when the US National Institute of Allergy and Infectious Disease released an usual late-night statement saying that the 79% efficacy rate AstraZeneca had reported for its vaccine may have been based on outdated data.
Slaoui left GSK in 2017, later becoming the head of President Donald Trump’s COVID vaccine effort, Operation Warp Speed. He also joined several biotech boards and a startup, Centessa, all of which distanced themselves from Slaoui after the allegation surfaced.
Megan Hernbroth published an exclusive look at how SoftBank’s Deep Nishar diligently vets healthcare and biotech investments, resulting in some of the highest returns on investments across the firm. The pressure is on for Nishar, and his cohort of biotechnology and life sciences portfolio companies, after a series of public investment catastrophes like WeWork and failed pizza robot maker Zume, she reported.
Scientists launched an ambitious research study on Thursday that aims to figure out how well Moderna’s coronavirus vaccine works to prevent people from spreading the virus to others.
We know Moderna’s shot is very good at preventing people from becoming sick with the disease. But we don’t yet know if vaccinated people could still harbor the virus, perhaps without showing symptoms, and pass it on to others.
To figure that out, researchers plan to recruit 12,000 students across 21 college campuses, including the University of Maryland, Texas A&M, and Indiana University. People interested in participating can register online at PreventCOVIDU.org.
“We hope that within the next five or so months, we’ll be able to answer the very important question about whether vaccinated people get infected asymptomatically, and if they do, do they transmit the infection to others,” Dr. Anthony Fauci, the nation’s top infectious-disease expert, said Friday at a White House COVID-19 taskforce briefing.
Half of the volunteers will receive Moderna’s coronavirus vaccine right away, while the other half will get their shots four months later. While compensation varies, some student volunteers can get paid almost $1,000 to participate.
Researchers will track the volunteers to see how well vaccination prevents coronavirus infections, including asymptomatic cases, and reduces viral transmission among their close contacts. Every day, volunteers will take swabs of their nose, place them into a bar-coded vial, and drop them off at collection boxes. The samples will then be sent to laboratories to be checked for the coronavirus.
The trial will hopefully deliver results in September, Dr. Larry Corey, a virologist at the Fred Hutchinson Cancer Research Center said in an interview. Corey has spearheaded the trial, helping design the study and advocating for funding since November, Insider previously reported.
“High-density housing, the impulse to socialize and less fear of severe disease in young people are all factors that contribute to the high burden of SARS-CoV-2 infection on college campuses,” Dr. Holly Janes, a professor at Fred Hutch and study leader, said in a statement.
Answering one of the largest unknowns around COVID-19 vaccines
The first COVID-19 shots, from Moderna and Pfizer, proved to be overwhelmingly effective in data first released in November 2020. The primary goal of those studies was to look at symptomatic cases of COVID-19, partly because it was an easier metric to track.
Those studies enrolled tens of thousands of people, and showed the shots were incredibly effective at preventing people from developing symptomatic cases cases of COVID-19. In Moderna’s study, the two-dose vaccine was 94% effective at preventing COVID-19 cases, when compared to people who got placebo shots.
The initial studies left open the possibility that immunized people could still be vulnerable to spreading the virus, potentially as unknowing asymptomatic carriers.
“It’s definitely an unknown,” Corey said. “In my circles, it’s been pretty well delineated that you don’t know whether you can asymptomatically transmit, and therefore you should still be careful around unvaccinated persons.”
That uncertainty has been a key reason public-health officials have urged the public, including vaccinated individuals, to continue wearing masks and socially distancing.
Delay in funding could take it longer to find an answer
While the original goal was to start this research in January, it took longer than expected to secure federal funding to run the study, the Wall Street Journal’s Peter Loftus reported in December. The emergence of variants, ramping up of vaccine supply, and recognition that the virus would likely become endemic helped move the study proposal along, Corey said.
The US National Institute of Health’s infectious-disease unit is funding the trial, and Corey said the funding is in the “high tens of millions.”
The delay may make it harder for the trial generate an answer. The US government is pushing to make all American adults eligible for vaccines by May 1. For volunteers who are randomly selected to receive the shot four months later, that means waiting until July.
Corey hopes a sense of altruism will convince volunteers to stick with the trial
The five-month follow-up period will also bleed into the summer for volunteers, when some will likely depart campuses. That could make it harder to track or keep people in the study. Corey said the trial sites will look to recruit students who want to stay on campus or live nearby, and he hopes a sense of altruism will retain volunteers, even if they can access a vaccine outside the trial.
“The reason to volunteer is to help the country answer this question for themselves and their parents and their relatives and their communities,” Corey said.
Despite those challenges, the biggest obstacle, securing funding to run the trial, has been overcome. The research has the potential to provide the best data yet to answer a question that will inform how quickly society can get back to a world without masking and social distancing.
And, in the process, some college kids can get the vaccine now and be paid help figure out the answer to this question. Compensation will vary by location to account for cost-of-living differences, and volunteers can make as much as $947 if they fully participate, a Fred Hutchinson spokesperson said.
Biotech companies are cutting ties with Moncef Slaoui, after the drug industry veteran was accused of sexual harassment and inappropriate conduct.
The allegations stem from Slaoui’s tenure at GlaxoSmithKline, the pharma company said in a statement on Wednesday. The company launched an investigation into the claims and substantiated them, GSK said.
Slaoui left GSK in 2017. Last year, he was tapped by President Donald Trump as the scientific head of the US vaccine effort, then known as Operation Warp Speed. He stepped down from that role in January at the request of the Biden administration.
On Wednesday, GSK said it fired Slaoui from the board of Galvani Bioelectronics, a startup in which it owns a majority stake. Slaoui also exited three other firms: Centessa Pharmaceuticals, Vaxcyte, and Medicxi.
In a statement late Wednesday, Slaoui apologized and said he was stepping back from his professional responsibilities.
“I have the utmost respect for my colleagues and feel terrible that my actions have put a former colleague in an uncomfortable situation. I would like to apologise unreservedly to the employee concerned and I am deeply sorry for any distress caused,” he said in the statement.
‘This simply should not have happened’
In a letter to GSK employees obtained by Insider, CEO Emma Walmsley said that the company received the sexual-harassment complaint in February and that the board “immediately initiated an investigation with an experienced law firm.”
“Protecting the woman who came forward and her privacy has been a critical priority throughout this time,” Walmsley wrote. “This will continue. I respect and admire her courage and strength. I’ve spent many nights lately putting myself in her shoes. More than anything, this simply should not have happened.”
Slaoui, who has a Ph.D. in molecular biology and immunology, spent nearly three decades ascending the ranks at GSK. Then he became well known as the face of the Trump administration’s ambitious effort to develop and mass-produce coronavirus vaccines. In January, he resigned at the request of President Joe Biden’s team.
Slaoui worked at GSK for almost 3 decades
Slaoui started at GSK in 1988 as a bench scientist. By 2006 he had joined GSK’s board of directors, and he oversaw the vaccines business starting in 2009. After retiring from GSK, Slaoui became a venture capitalist, joining the firm Medicxi as a partner in 2017.
Medicxi said on Thursday that Slaoui had stepped down from his role as a partner at the firm.
Vaxcyte, where Slaoui served as chairman, said it requested his resignation when it learned of the allegations against him. Centessa, a biotech startup, said Slaoui has left his role as chief scientific officer.
Slaoui also served on the board of coronavirus-vaccine maker Moderna from 2017 to 2020. In a statement, Moderna said it “was not aware of these or any other allegations of improper conduct by Dr. Slaoui.” The company declined to comment further.
Walmsley said in her memo that she was “shocked and angry about all of this, but I’m resolute.”
“We are in an age of progress with a female CEO, growing ranks of female leaders, new commitments to diverse representation, and a culture that values speaking up,” Walmsley wrote. “I expect everyone to represent GSK with integrity – especially senior leaders.”
A vaccine-research site in Rockville, Maryland, that opened in December 2016 and was named after Slaoui will be renamed, she added.
This article has been updated with Slaoui’s departures from Centessa, Vaxcyte, and Medicxi.
In a rare public rebuke, the top US infectious disease doctor is criticizing the pharma company AstraZeneca for statements it recently made about its coronavirus vaccine.
Dr. Anthony Fauci said on Tuesday that AstraZeneca’s Monday press release about its COVID-19 vaccine “wasn’t completely accurate.”
On Monday, AstraZeneca announced success in a 32,000-person clinical trial conducted mainly in the US. The news was supposed to provide a much-needed moment of clarity on the two-dose vaccine. Instead, the announcement has become the latest controversy facing the program, which has already faced a string of confusion from public missteps by the company.
AstraZeneca said Tuesday it would release the “most up to date efficacy data” within 48 hours.
In Tuesday morning interviews, Fauci elaborated on the late-night statement from US health authorities. He told the health news publication STAT that he was “sort of stunned” by AstraZeneca’s press release.
AstraZeneca’s release said the study showed the vaccine was 79% effective at preventing symptomatic disease and 100% effective at stopping severe disease. That interim analysis included 141 cases of COVID-19 among trial participants and five cases of severe disease.
The expert panel took issue with the company announcing interim results based on data that was current as of February 17. Fauci, the nation’s top infectious-disease expert, said that the full dataset still shows the shot is safe and effective at preventing COVID-19.
By basing its release on an early view of the data, AstraZeneca may have made its vaccine appear better, leading the data and safety monitoring board to write “a rather harsh note” to the company saying the release was misleading, copying Fauci on the letter, he said.
“If you look at it, the data really are quite good, but when they put it into the press release, it wasn’t completely accurate,” Fauci told “Good Morning America.” “We have to keep essentially trying as hard as we can to get people to understand there are safeguards in place.”