Some covid vaccine developers may publish interim data from their end-stage trials over the next several weeks. There is no approved COVID-19 vaccine yet, but several are in advanced trials, including those by Pfizer Inc, Johnson & Johnson, AstraZeneca-Oxford University, Novavax, and Moderna.
Pfizer and its partner BioNTech could have late-stage clinical data as early as the end of October, vaccine manufacturers said previously. “Based on current infection rates, companies continue to hope that a conclusive reading on efficacy is likely by the end of October,” Pfizer said earlier this month as it sought approval from the US regulator to expand its trial to 44,000 participants. .
Data from Moderna is also expected soon after. Johnson & Johnson and Novavax have also recently started their own last-stage tests and may have data for the next several months.
Meanwhile, a top Russian scientist behind his Sputnik V covid vaccine told Reuters that Moscow plans to publish interim results based on the first 42 days of volunteer monitoring. If Russia can publish provisional data from the final stage trials, it stands a good chance of becoming the first country in the world to announce data from a final stage trial.
The first of 5,000 volunteers in Russia was vaccinated on September 9, which means that interim results could be published sometime after October 21. Russia’s sovereign wealth fund, which has invested in the launch of the vaccine, has said it expects the interim results to be released. in October or November.
A number of Western developers are conducting final stage tests that have been running for over 42 days now, but have not released any interim results. The results of their early-stage trials were peer-reviewed and published in The Lancet. Russia had approved a covid vaccine in August even before the final stage of trials.
The head of the Food and Drug Administration office that oversees vaccines said drug manufacturers developing Covid-19 injections are aware of the data that will be required to obtain an emergency use authorization, regardless of whether the agency provides a formal guide.
“Companies know what we’re waiting for,” said Peter Marks, director of the FDA’s office of biologics, at an event Tuesday.
The US agency has scheduled a meeting of external experts on October 22 to discuss a vaccine.
“On October 22, 2020, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the Center for Biological Evaluation and Research (CBER) will meet in open session to discuss, in general, the development, authorization and / or licensing of vaccines to prevent COVID-19 No specific application will be discussed at this meeting. (With contributions from the agency)
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