(Washington) The Pfizer / BioNTech alliance on Monday asked U.S. health officials for future approval of a third dose for all of their COVID-19 vaccines, with encouraging preliminary results.
Posted on Aug 16, 2021 at 1:08 pm
“The data we have seen so far suggest that a third dose of our vaccine elicits antibody levels well in excess of the two originally planned doses,” said Albert Bourla, CEO of Pfizer, in a press release.
The two companies have therefore “submitted phase 1 data” [d’essais cliniques, NDLR] to the US Food and Drug Administration to assist in the evaluation of a third dose or booster dose of the COVID-19 vaccine for future approval, ”the statement said.
These results will also be presented to the European Medicines Agency (EMA) and other regulatory authorities “in the coming weeks”, it said.
Pfizer had already communicated these results, which relate to the initial strain of the virus, but also to the beta and delta variants, the latter being the source of a strong resurgence of the epidemic around the world.
This booster dose, given between 6 and 12 months after the first two injections, “could help reduce infection and disease rates in previously vaccinated people and better control the spread of variants of the virus,” said Ugur Sahin, who Head of BioNTech.
“Phase 3 results are expected shortly and presented to the FDA, EMA and other regulatory agencies around the world,” the statement said.
Some preliminary studies, as well as observations in Israel, have recently raised concerns about reduced effectiveness of Pfizer’s vaccine against infection with the Delta variant, although protection against severe cases of the disease remains very good.
Nevertheless, the vaccine does not “yet” have to be adapted to the new variants currently in circulation, confirmed Ugur Sahin at the beginning of August and instead advocated this third dose.
The United States last week approved an additional dose of the messenger RNA vaccine (Pfizer or Moderna) for some immunocompromised people, despite calls from the World Health Organization (WHO) to postpone product recalls to address the gaping vaccine inequalities between rich and too eliminate poor countries.
And more categories of the American population could follow in the near future.
An advisory committee from the Centers for Disease Prevention and Control (CDC), the leading US federal public health agency, will meet in late August to discuss the benefits of an additional dose for adults over 65, nursing home residents and healthcare professionals.