Biden has also said on several occasions that all Americans who wish to be vaccinated should be able to do so by July.
Vaccine makers have also discussed the growing threat from different strains of coronavirus such as B.1.315, the variant first found in South Africa and which appears to be less sensitive to certain vaccines.
Moderna is starting trials with the National Institutes of Health for a booster shot targeting this strain. Pfizer is in talks with the FDA about clinical study designs to test updated versions of its own vaccine against emerging variants, said chief commercial officer John Young.
Novavax, which just completed trial registration in the United States this week for its large Phase III trial, is already actively working on a strategy to provide the broadest coverage, said John Trizzino, chief commercial officer and commercial director. He added that the company’s technology and manufacturing process make it easy to modify and scale modified vaccines.
The FDA updated its vaccine guidelines just a day earlier to flesh out some of its expectations for modified or booster injections targeting variants. While the agency’s chief vaccine officer, Peter Marks, told reporters that the modified vaccine trials could recruit a few hundred people far from the tens of thousands of people enrolled in typical Phase III trials for vaccines, these details were not indicated in the document.
We hope we will be able to do this without large Phase III trials, said Hoge, who added that the company has had productive conversations with the FDA about its human trials that will begin soon.
Pfizers Young said it would be ideal to take an influenza vaccine approach with these modified vaccines. Influenza vaccines are changed slightly each year to tackle important new strains and don’t go through lengthy phase III trials for the changes. We certainly think this is more of a seasonal flu-like process, where a new variant [vaccine] could be able to demonstrate safety and immunogenicity in a smaller number of patients, could be a much faster way to be able to ship a new vaccine variant to patients in this country.
The FDA has not ruled out rapid approvals of modified vaccines in the future, saying in Monday’s guide that further discussions will be needed “to decide whether the agency may at some point authorize the modified Covid-19 vaccines” without the need for clinical studies. “
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