Covid-19 roundup: FDA and NIH leaders continue sharing lessons from the pandemic; Slovenia halts J&J vaccine rollout to investigate death — report
Back in March, FDA acting commissioner Janet Woodcock and NIH director Francis Collins began the long, slow process of explaining some of the lessons they’ve learned since the start of the Covid-19 pandemic — ranging from the lack of research infrastructure to the importance of partnerships with industry.
Yesterday, they went into round 2 on what needs to change in preparation for the next pandemic, pointing to the White House’s $65 billion Pandemic Preparedness Plan.
According to Woodcock, the FDA has analyzed and collected information from January through May of this year on the federal government’s overall response to the pandemic — condensing everything into a draft of 29 recommendations. Some of them have been repeatedly called for by Woodcock and Collins, such as investments into public health infrastructure and improving the structure of clinical trials.
“If we’re really serious about preparing for the next pandemic, while we’re still trying to finish dealing with this one, it’s going to take resources,” Collins said.
One of the points in the Biden administration’s plan included vaccine development and distribution, with the proposal calling for $24.2 billion in spending to develop and manufacture shots within 100 days after a new threat has been detected, a feat Pfizer CEO Albert Bourla has said his company can accomplish. Officials would ideally deliver enough shots for every American in the subsequent 30 days, followed by the global population in the 70 days after that, according to the plan.
This would be a significant change of pace, considering the average timeframe for a vaccine to go from R&D through testing and market approval currently takes years, not months. Even with the Covid-19 vaccines, it took 9 months to start distribution, and that was the fastest launch ever. Essentially, the plan calls for going from identifying a potential pandemic to making close to 8 billion doses in less than seven months.
While Woodcock praised the amount of collaboration between inter-governmental agencies over the course of the pandemic, Collins emphasized the importance of public-private partnerships, like the one known as ACTIV, which came together to prioritize different therapeutic candidates. — Paul Schloesser
Slovenia halts J&J vaccine rollout to investigate death — report
Several months after the US lifted its hold on J&J’s Covid-19 shot, another country has temporarily suspended the vaccine over the death of a young woman, Reuters reported.
Slovenia is halting the distribution of J&J’s single-dose vaccine as it investigates the death of a 20-year-old woman, according to the national STA news agency. The woman, who died within two weeks of receiving the shot, had both blood clots and bleeding in the brain, according to Reuters.
“I can’t make comments, but the conditions have been met for clarifying all the circumstances of what happened,” said Igor Rigler, a neurologist at the Ljubljana hospital center, per Reuters.
The FDA and CDC jointly decided to stop administering J&J’s shot in the US back in April after receiving reports of a rare but serious type of blood clot. Most cases have occurred in women between the ages of 18 and 49, and some have been fatal, the FDA said at the time. However, regulators lifted the pause less than two weeks later, deciding that the vaccine’s known and potential benefits outweigh the risks.
The agency updated fact sheets for vaccine recipients to note the risk of blood clots and low levels of platelets, also known as thrombosis with thrombocytopenia syndrome. Over in Europe, the EMA’s safety committee also recommended adding a warning to the label regarding the risk of clots.
In July, the FDA added a second warning to the vaccine’s label, after data was discovered “connecting the shot to an increased risk” of Guillain-Barré syndrome, a rare condition where the body’s immune system attacks its nerves. Once again, the agency emphasized that the benefits of taking the vaccine “clearly” outweigh the risks. — Nicole DeFeudis
FDA reportedly considers a half-dose of Moderna vaccine — but some Americans aren’t waiting
After authorizing a booster shot of Pfizer’s Covid-19 vaccine for certain high-risk individuals, regulators are reportedly considering half-dose boosters of the Moderna vaccine, according to Bloomberg News.
Ahead of an upcoming announcement, unnamed sources told Bloomberg on Tuesday that the FDA is leaning toward authorizing 50-microgram booster shots of Moderna’s vaccine. The company’s initial shots were 100-microgram doses, compared to the Pfizer shot, which has been authorized for 30-microgram initial doses followed by a 30-microgram booster.
Authorizing a third half-dose would allow Moderna to put out more doses in the near-term, while lowering the risk of side effects, Bloomberg reported.
The news comes a week after the FDA authorized a third Pfizer shot for some people, including those over 65 years old, at high-risk of severe Covid-19, or those whose “institutional or occupational exposure” put them at risk. That includes groups like teachers, grocery workers, and those in prisons or homeless shelters.
The FDA’s OK is much narrower than Pfizer had hoped. The pharma had initially applied for supplemental approval of the booster shot for anyone who’s eligible for the initial shots.
But some Americans aren’t waiting for the FDA’s blessing to get their third shot. According to a Wall Street Journal report, doctors and pharmacies are rapidly administering the shots, oftentimes without proof of eligibility. Some patients have reported getting a third dose of the Moderna vaccine — which is not yet authorized — with no trouble at all. CVS spokesperson Michael DeAngelis told the WSJ that the chain is doling out third Moderna doses to those who self-attest to their eligibility. — Nicole DeFeudis
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