Moscow. July 9. INTERFAX.RU – Pfizer and BioNTech are planning to seek approval from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the third dose of COVID-19 vaccine.
Pfizer and BioNTech have received “encouraging data” from an ongoing booster shot test, the companies said.
“Baseline data from the study demonstrate that a booster dose administered 6 months after the second dose (…) elicits an immune response with antibody titers that are 5-10 times higher than after two doses,” it said.
It is noted that the companies plan to publish more accurate data in the near future, as well as provide them to the FDA, EMA and other regulatory bodies in the coming weeks. U.S. health officials have so far said it is unclear if a booster shot is needed. For example, the chief US infectious disease specialist, Anthony Fauci, earlier on Thursday confirmed that two injections of the Pfizer and Moderna vaccines even protect against the “delta” variant.
However, as the companies noted, data released by the Israeli Ministry of Health show that “the vaccine's effectiveness in preventing both infection and symptomatic disease declined six months after vaccination, although its effectiveness in preventing serious illness remains high.”
Thus, companies are convinced that “a third dose may be required within 6-12 months after full vaccination” “to maintain the highest level of protection.” Pfizer also said it is preparing to begin clinical trials of a modified vaccine specifically for the delta variant in August, if necessary.
