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has until June to decide if we need new vaccines for this fall, FDA official says


A volunteer receives a vaccine injection while participating in a coronavirus disease (COVID-19) vaccination study at the Research Centers of America in Hollywood, Florida on September 24, 2020.

Mark Bello | Reuters

The FDA has until early summer to decide whether vaccine makers should modify existing Covid vaccines to target different virus variants to avoid a possible further rise in cases this fall, a senior FDA official says. drug regulatory body.

Dr. Peter Marks, who heads the FDA’s office responsible for vaccine safety and effectiveness, told the drug regulator’s advisory committee on Wednesday that a decision should be made by June in order to have vaccines available in the fall. Marks said the United States could face another wave of infection then, as the virus will continue to evolve as immunity to current vaccines wanes.

Robert Johnson, a senior official at the Biomedical Advanced Research and Development Authority, told the meeting that the biggest challenge in updating vaccines will be coordination between vaccine makers to ensure they focus on good covid variants.

Pfizer, Moderna and other vaccine makers are conducting clinical trials of omicron-based vaccines. However, the companies are not currently coordinating their new vaccine formulas, according to Jerry Weir, head of the FDA’s viral products division. Several members of the FDA’s advisory committee said public health authorities need to develop a unified approach among vaccine makers, similar to their work updating the flu vaccine to target new strains each year.

FDA committee member Dr. Paul Offit said the CDC needs to take the lead in deciding when vaccines are no longer effective against serious diseases, so that the FDA and the National Institutes of Health can then work with them. companies to determine the best path. forward on a new move.

“On some level, companies are kind of dictating the conversation here,” Offit said. “You often hear that the company now has an omicron-specific vaccine, or a vaccine that they can now combine with the flu vaccine. It shouldn’t come from them, it really has to come from us .”

FDA officials have offered to use the process of developing new flu vaccines as a guide to changing Covid vaccines. Each year, the World Health Organization makes a recommendation on the composition of the flu vaccine. The FDA then makes its own decision, based on a recommendation from its committee, on which strain to use for injections in the United States.

The uncertainty over the trajectory of Covid’s evolution, unlike the predictability of influenza, makes it difficult to determine how vaccines should be updated – or if they even need a change at all.

According to CDC data presented at the meeting, three doses of Pfizer or Moderna vaccines were more than 80% effective in preventing hospitalization in healthy adults during the omicron wave. But the companies’ vaccines are still based on the original version of the virus that emerged in Wuhan, China, and their effectiveness against infection has declined significantly since the pandemic began.

Covid mutated two to 10 times faster than the flu, depending on the strain of the latter virus, according to Trevor Bedford, a virologist at the Fred Hutchinson Cancer Research Center. Bedford said he expects the spike protein, which the Covid virus uses to invade human cells, to continue to evolve. Vaccines target the spike, and as the protein mutates, the effectiveness of injections may decrease.

Bedford said the most likely scenario over the next year is omicron and its subvariants will evolve to become more transmissible and further evade immunity from vaccination and infection. However, he said it’s hard to predict whether another highly mutated variant will disrupt the pandemic response the way omicron did over the winter.

“We really don’t know if these wildly divergent viruses will be a common feature or a rare feature of the endemic evolution of SARS-CoV-2,” Bedford said, using the scientific name of the virus that causes Covid.

Johnson noted that in the case of influenza, vaccine makers are able to develop production plans in advance based on a stable seasonal market. However, it is not yet clear whether Covid will follow a predictable seasonal pattern similar to influenza, according to Dr Kanta Subbarao, a virologist who works on influenza for the World Health Organization.

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FDA committee members said the central question in updating a vaccine is what metric public health authorities should use to determine when shots have lost their effectiveness. Scientists have yet to determine whether a certain level of antibody generated by a vaccine translates to clear protection against the virus, according to Dr. Cody Meissner, an infectious disease expert at Tufts University School of Medicine.

As a result, public health authorities will have to rely on hospitalization rates to determine whether the vaccine is losing effectiveness, Meissner said. However, it is also unclear whether national hospitalization data is primarily made up of patients admitted due to the virus or people who test positive after being admitted for other reasons. Meissner pointed to data from Massachusetts that showed 65% of the 219 people hospitalized with Covid as of April 5 were actually admitted for reasons other than the virus.

Dr. Amanda Cohn, a CDC official, told the committee that repeated reinforcement is not a sustainable public health strategy. Cohn said the efficacy of vaccines against hospitalization remains high, and society may have to accept some level of infection which it can then treat with antiviral pills that are now on the market.

The FDA last week authorized fourth injections for adults 50 and older without consulting the committee, a decision that has divided scientists and doctors, some of whom believe there is not enough data to make a decision. in charge of additional injections. Marks said the FDA did not consult with the committee because the drug regulator viewed the clearance as a way to give people more vulnerable to serious illnesses additional protection until a broader decision is made. for the rest of the population.

“I think we’re totally okay with it and the idea that we just can’t stimulate people as often as we are,” Marks told the committee. “I’m the first to acknowledge that this fourth additional booster dose that was authorized was an interim measure until we put things in place for the next potential booster given the emerging data,” Marks said.


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