European regulators are watching J&J’s vaccine for unusual blood clots

Vaccine
Registered Nurse Robert Orallo administers the Pfizer Covid-19 vaccine at the Blood Bank of Alaska in Anchorage on March 19, 2021.

  • European regulators are investigating whether Johnson & Johnson’s vaccine could cause blood clots.
  • The investigation was opened after four cases were reported, including one fatality.
  • J&J’s vaccine was authorized for European distribution last month, but hasn’t been given out yet.
  • See more stories on Insider’s business page.

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.

Approximately 4.9 million doses of J&J’s vaccine have been administered in the US, according to the CDC.

It’s not the first time the link between vaccines and blood clots has been investigated

The EMA has been closely watching reports of blood clots linked to another vaccine: AstraZeneca’s two-dose immunization.

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.

Cases of blood clots have also reported in patients who had received Moderna and Pfizer’s vaccines, a J&J spokesperson said in a statement.

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.

Read the original article on Business Insider

Experts are worried about the rise of vaccine skepticism

Hello,

Welcome to Insider Healthcare. I’m Lydia Ramsey Pflanzer, and this week in healthcare news:

If you’re new to this newsletter, sign up here. Tips, comments? Email me at lramsey@insider.com or tweet @lydiaramsey125. Now, let’s get to it…


First, some personal news – I got my first vaccine dose this week! As eligibility expands across the US, I’m excited to keep cheering on everyone who’s getting a dose (or two!).

As the mRNA started to tell my body how to mount an immune response, I read up on what Dr. Anthony Fauci told Aylin Woodward in an exclusive interview about vaccines.


Veran France vaccination health minister AstraZeneca
French Health Minister Olivier Veran receives a dose of the AstraZeneca-Oxford Covid-19 vaccine.

Oh, AstraZeneca…

It was another tough week for the vaccine from AstraZeneca and Oxford University.

European regulators said on Wednesday that they consider rare blood clots that can be fatal a side effect of AstraZeneca’s coronavirus vaccine.

Also on Wednesday, UK regulators cited the rare blood clots as a reason why people under 30 should no longer be offered the AstraZeneca vaccine.

Germany and France are recommending that some people who got a first dose of the AstraZeneca vaccine switch to a different immunization for their second shots.

In the wake of the European regulators’ decision, we talked to experts to find out what they make of the rare side effect.

Their biggest worry is around the skepticism that’s growing around the vaccine.

Find out more>>

Getting AstraZeneca’s shot is safer than flying on a plane, experts say – the bigger problem is an ‘explosion of vaccine skepticism’


healthcare ceos 4x3

CEOs’ big paydays

Health insurance and health systems CEOs scored major paydays in 2020, despite a tumultuous year.

HCA’s CEO took home $83.6 million, and Cigna’s CEO made nearly $79 million.

Speaking of health insurers – the Centers for Medicare and Medicaid Services on Thursday said who it plans to work with in the first year of the direct contracting program.

It’s a lot of familiar names, like Clover Health, Oak Street Health, and more.

Also included is Humana, whose CEO is one of the 8 whose compensation we break down for 2020.

See the full chart>>

How 8 top healthcare execs scored massive paydays despite the pandemic


scales

The state of the digital weight loss industry

This week, Patricia Kelly Yeo took a closer look at the digital weight loss industry.

Investors have put millions into app-based approaches to weight loss. But experts Kelly talked to aren’t convinced it’s anything all that new.

These apps are hoping to gain popularity at a time when the weight loss market is shrinking.

Check it out>>

A new wave of digital weight loss companies are raking in millions in funding by relying on decades-old psychology principles, experts say


I’ll leave you with a new spot to find the pitch decks we’ve reported on over the years.

From seed and Series A to late-stage funding, here are the presentations healthcare startups used to raise millions from top VCs.


– Lydia

Read the original article on Business Insider

AstraZeneca’s COVID-19 shot will come too late for the US

astrazeneca
  • AstraZeneca’s coronavirus vaccine faces a murky future in the US, where three other shots are already in use.
  • Public-health experts said the two-dose vaccine should secure an emergency OK from US regulators.
  • Despite that OK, the US may end up giving its AstraZeneca supply to other countries, they said.
  • See more stories on Insider’s business page.

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 opinion has 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.

COVID vaccine selfie
Dr. Prakash Patel, a pulmonologist at Tristar StoneCrest Medical Center, takes a selfie with a nurse after getting his COVID-19 vaccine.

“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.

Dr. Maria Elena Bottazzi
Dr. Maria Elena Bottazzi.

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.

In contrast, South African health regulators stopped distributing AstraZeneca’s vaccine after a study found the vaccine was 22% effective at preventing mild-to-moderate COVID-19 in the country, and just 10% effective when looking only at cases caused by the B.1.351 variant.

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.

Donating doses would bring the most global impact

The vast majority of COVID-19 vaccine doses have gone to rich nations in the first months of the rollout, according to Bloomberg’s global vaccination tracker. AstraZeneca’s vaccine has been one of the few programs that holds promise in helping not just wealthy countries but low- to middle-income nations, because the company is selling it at cheaper prices and also has said it can produce up to 3 billion doses in 2021.

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.

Read the original article on Business Insider

Countries like Germany, France, and Canada temporarily stopped using AstraZeneca’s vaccine after reports of rare blood clots. There is no evidence to restrict the use of the shot, Europe’s regulator says.

GettyImages 1231181187
A vaccinator administers an injection of AstraZeneca/Oxford Covid-19 vaccine to a patient at a vaccination centre in Chester, northwest England, on February 15, 2021.

  • The benefits of AstraZeneca’s COVID-19 vaccine outweighs its risks, the European Medicines Agency said.
  • “There is no evidence to restrict the use of the vaccine in any population,” it said Wednesday.
  • The EMA’s investigation into reports of rare side effects it ongoing and will conclude next week.
  • See more stories on Insider’s business page.

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.

Read more: COVID-19 Vaccine Tracker: AstraZeneca’s shot proves safe and effective and is headed to the FDA

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.

Read the original article on Business Insider

Scientists are reaching a new understanding about Alzheimer’s disease

Hello,

Welcome to Insider Healthcare. I’m Lydia Ramsey Pflanzer, back after a week away to ski and feeling refreshed. Today in healthcare news:

If you’re new to this newsletter, sign up here. Comments, tips, tricks for successfully scheduling vaccine appointments in the state of Colorado? Email me at lramsey@insider.com or tweet @lydiaramsey125. Now, let’s get to it…


alzheimers research 4x3

Scientists are coming around to a surprising new understanding of Alzheimer’s disease, and it could supercharge drug development for the $1.1 trillion problem

Find out more here>>


Vaccine distribution

CDC: Real-world data shows Pfizer’s and Moderna’s COVID-19 vaccines are 90% effective at preventing infection

Get the full story here>>


One of Crossover Health's exam rooms at its Midtown, Manhattan location.
One of Crossover Health’s exam rooms at its Midtown, Manhattan location.

An investor presentation lays out how a key healthcare partner for Amazon is thinking about the future of its business

See the presentation here>>


More stories we’re reading today:


Lydia

Read the original article on Business Insider

AstraZeneca had another rough week

Happy Friday everyone,

We’ve made it through another week, and another onslaught of healthcare news. I’m Allison DeAngelis, and I’ll lead you through the takeaways:

If you’re new to this newsletter, sign up here.

Do you have comments or tips about biotech and pharmaceutical companies? You can email me at adeangelis@insider.com or tweet @ADeAngelis_bio. I will also accept your favorite memes from this Suez Canal situation.

Suez canal ever given
The Ever Given, trapped in the Suez Canal.

Now, let’s dig in (pun intended).


fauci vaccine timeline
Dr. Anthony Fauci.

COVID vaccines under the microscope

If I never hear the word “unprecedented” again, I’ll be very happy. But for now, we’re still dealing with the pandemic.

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.

Read the full story here >>

AstraZeneca revises down its vaccine efficacy in a huge US trial, to 76% from 79%, following concerns from Fauci and other experts that the results were outdated


Moncef Slaoui
Dr. Moncef Slaoui, chief adviser to Operation Warp Speed.

Biotechs cut ties with Moncef Slaoui

This week, Andrew Dunn and I covered the fallout from a “substantiated” allegation that Moncef Slaoui sexually harassed a female employee during his time at GlaxoSmithKline.

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.

Read the full story here >>

Moncef Slaoui is retreating from the biotech industry after facing a substantiated sexual-harassment claim


masayoshi son softbank
Deep Nishar

SoftBank turns to Deep Nishar and biotech bets

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.

Check out the full story here >>

Biotech founders are turning to Deep Nishar as a must-have investor. The SoftBank exec explains the strategy behind his winning bets.

– Allison

Read the original article on Business Insider

Do COVID-19 vaccines stop transmission? Top scientists are now recruiting thousands of college students to find out

Coronavirus vaccine Moderna trial college students transmission study
Richard Biggs, 20, an evolutionary biology major at the University of Colorado Boulder gets his first dose of the Moderna vaccine.

  • A study launched on Thursday to see how well Moderna’s COVID-19 vaccine stops the spread of the virus.
  • The clinical trial will recruit 12,000 college students across 21 campuses.
  • Scientists hope it will tell us how well vaccines prevent asymptomatic infections and stop transmission.
  • See more stories on Insider’s business page.

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.

Scientists zeroed in on colleges as an ideal place to carry out this research. One nationwide study found nearly 400,000 COVID-19 cases on campuses since reopening last fall.

“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.

While real-world data gives hopeful signs the shots have a marked impact on reducing infections, this study will attempt to answer that question in a rigorous manner.

Delay in funding could take it longer to find an answer

Moderna coronavirus vaccine trial college students transmission asymptomatic infection study
Olivia Parsons, 22, a neuroscience major at the University of Colorado Boulder, left, gets her first dose of the Moderna vaccine.

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.

Read the original article on Business Insider

Moncef Slaoui is retreating from the biotech industry after facing a substantiated sexual-harassment claim

Moncef Slaoui
Moncef Slaoui, the former chief advisor to the White House’s Operation Warp Speed vaccine initiative.

  • Moncef Slaoui, the former head of Operation Warp Speed, is facing a sexual-harassment allegation.
  • His former employer GlaxoSmithKline said an investigation “substantiated the allegations and is ongoing.”
  • The complaint is from several years ago when Slaoui worked at GSK. He left the company in 2017.
  • See more stories on Insider’s business page.

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’

Emma Walmsley
GlaxoSmithKline CEO Emma Walmsley.

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.

Read the original article on Business Insider

Moncef Slaoui exits biotechs after a sexual harassment allegation

Pills 2 (2)

Good morning. Welcome to Insider Healthcare. This is senior healthcare reporter Andrew Dunn filling in with today’s healthcare news:

If you’re new to this newsletter, sign up here. For tips in the biotech and pharma space, particularly on COVID-19 vaccines, email me at adunn@insider.com.


Moncef Slaoui
Moncef Slaoui, the former chief adviser to Operation Warp Speed.

Moncef Slaoui, the former head of Warp Speed, has exited 3 biotech firms after facing a ‘substantiated’ sexual-harassment claim

Read more about the complaint here>>


covid vaccine card cdc
ICU nurse Megan Tschacher shows off her vaccination card.

Since January, there’s been a 300% spike in dark net ads for COVID vaccines, fake vaccine cards, and fake test results

Read more about 1,200 online vendors purporting to have COVID-19 shots>>


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‘Hot vax summer’ is coming, and it’s set to be a blissful release of pent-up horniness

Read more about sultry summer plans>>


More stories we’re reading today:


– Andrew

Read the original article on Business Insider

‘It wasn’t completely accurate’: Fauci criticizes AstraZeneca’s COVID-shot disclosure, calling it an ‘unforced error’

fauci
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, speaks during a Senate Health, Education, Labor and Pensions Committee hearing on June 30, 2020 in Washington, DC. Top federal health officials discussed efforts for safely getting back to work and school during the coronavirus pandemic.

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.

The National Institutes of Health’s infectious-disease unit, which Fauci leads, issued an extraordinary statement shortly after midnight on Tuesday. The board of independent experts that oversees the study “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the statement said.

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.

“This is really what you call an unforced error,” Fauci said in a “Good Morning America” interview Tuesday.

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.”

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