Pfizer to seek emergency US clearance for third booster dose

Laboratories Pfizer and BioNTech jointly announced Thursday that they will seek regulatory approval for a third dose of their covid-19 vaccine..

The companies hope to publish more definitive data soon, as well as in a peer-reviewed journal, and plan to submit the data to the FDA. [agencia estadounidense de Alimentos y Drogas], at the EMA [Agencia Europea de Medicamentos] and other regulatory authorities in the coming weeks, ”a statement read.

It’s a statement, both companies expressed their belief that a third injection of their current vaccine, which requires two doses, has the potential to maintain the “highest levels” of protection against all current variants., including delta.

The announcement comes after data from an ongoing test showed that a third dose increases antibody levels five to ten times more against the original strain of coronavirus and the beta variant., first found in South Africa, compared to the first two doses, according to the text.

However, they noted that they are vigilant and are developing an updated version of the vaccine.

“As real-world evidence released by Israel’s health ministry shows, the vaccine’s efficacy declined six months after vaccination, at the same time as the delta variant became dominant in that country.The companies said in a statement collected by various local media.

The pharmaceutical companies noted that the results in Israel are consistent with studies by companies that previously reported that a third dose of the vaccine might be needed six to twelve months after the second injection.

The scientific director of the pharmaceutical company, Mikaël Dolsten, he said that the recently reported decline in vaccine effectiveness in Israel was mainly due to infections in people who had been vaccinated in January or February. Israel’s health ministry said the vaccine’s effectiveness in preventing infections and symptomatic illnesses fell to 64% in June.

“The Pfizer vaccine is very active against the Delta variant“Dolsten said in an interview. But after six months, he pointed out,”the risk of reinfection is likely because the antibodies, as expected, decrease”.

From Pfizer, they pointed out that data from Israel and Britain suggests that even with declining antibody levels, the vaccine is still about 95% effective against severe disease.

According to the note, lClinical trials could start in August, if they have the authorizations of the competent authorities.

The delta variant, which is the one that worries the WHO the most, was identified in seven new countries last week and already exceeds 100. In the United States, it already represents more than 50% of the samples sequenced.

The Chief Epidemiologist of the United States Government, Anthony Fauci said today that the three vaccines approved in the United States against covid-19 – Pfizer, Moderna and Johnson & Johnson – “are effective against the delta variant” according to the first studies on its effectiveness against this new variation.

(With information from AFP and EFE)

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