Covid-19 roundup: J&J to apply for booster authorization this week as adcomms are set; BioNTech CEO Ugur Sahin predicts need for new vaccine formulation
Two weeks after releasing new data showing its Covid-19 booster shot bumped protection against moderate to severe disease up to 75% worldwide, J&J is reportedly preparing an application for the FDA.
The pharma is planning on asking US regulators early this week to authorize its Covid-19 booster shot, unnamed sources told the New York Times.
The FDA authorized Pfizer and BioNTech’s booster shot last month, and is reportedly considering a half-dose booster of Moderna’s vaccine. The agency put out word Friday that its Vaccines and Related Biological Products Advisory Committee will meet on Oct. 14 and 15 to discuss Moderna and J&J’s boosters, respectively.
The adcomm will also hear presentations on “mix-and-match” boosters, or the use of a different vaccine than the one used for the primary series. And on Oct. 26, the adcomm will review an expansion of Pfizer’s EUA to allow the vaccine’s use in children 5 through 11 years of age.
A couple of weeks ago, J&J unveiled data from the Phase III ENSEMBLE 2 study, which looked at booster shots at two different points in time: a second shot 56 days after the first shot, or a second shot six months after the first. The eight-week shot showed increased protection against moderate to severe Covid-19 to 75% globally, and 94% in just the US, according to the company.
Protection against severe Covid-19 at least 14 days post-final vaccination was 100%, J&J said. While the eight-week shot led to a four- to six-fold increase in antibodies, the six-month booster showed a nine- to twelve-fold increase, regardless of age.
A panel of scientists and doctors who gathered to discuss Pfizer’s booster shot a couple of weeks ago suggested that those who received J&J’s single-dose vaccine may need boosters more urgently.
“To me, the biggest policy question out there is the Johnson & Johnson [booster],” said Helen Keipp Talbot at Vanderbilt University, a member of the CDC’s Advisory Committee on Immunization Practices, per NPR. “I worry we’re getting distracted by the question of boosters of Pfizer when we have bigger and more important things to do in the pandemic.”
BioNTech CEO Ugur Sahin predicts need for new vaccine formulation
Pfizer CEO Albert Bourla predicted a return to normalcy in the US within a year on ABC last week — but made clear that vaccines will be a big part of the solution. BioNTech CEO Ugur Sahin reiterated that sentiment this week, suggesting that a new formulation of the companies’ vaccine will likely be necessary to tackle new variants.
“This virus will stay, and the virus will further adapt,” Sahin told the Financial Times. “We have no reason to assume that the next generation virus will be easier to handle for the immune system than the existing generation. This is a continuous evolution, and that evolution has just started.”
While the current formulation of Pfizer and BioNTech’s Covid-19 appears to be sufficient against mutations like the Delta variant (the FDA authorized a third booster dose last month), new mutations could emerge that evade the vaccine’s protection, requiring a more “tailored” version of the shot, Sahin told the FT. He predicts a new vaccine could be needed by the middle of next year.
Other experts have also suggested that updated vaccines could be necessary, much like the flu shot that’s targeted each year toward prominent strains. Upon reading out data from its own variant-specific booster candidate back in April, Moderna CEO Stéphane Bancel told Endpoints News that high-risk individuals could be looking at several boosts over the course of the next two years.
“We think over time, maybe a boost per year might be enough, especially if combined with your flu boosts,” he said at the time.
EMA recommends Pfizer booster shot for 18+
The European Medicines Agency on Monday recommended the Pfizer booster shot at least six months after the second dose for those older than 18. The EMA said the recommendation is based on a review of Pfizer data showing a rise in antibody levels when a booster dose is given approximately 6 months after the second dose in people 18 to 55 years old.
The agency also recommended that immunocompromised people can receive boosters from either the Pfizer or Moderna shots, at least 28 days after their second dose.