Pfizer to seek authorisation for a third dose of its vaccine for greater protection

Pfizer and BioNTech will seek clearance from the US Food and Drug Administration (FDA) for a third booster dose of its vaccine to offer greater protection against COVID-19.

In a statement, both companies said they have seen "encouraging data" from an ongoing trial of the booster vaccine, adding that it provides five- to 10-fold higher levels of neutralising antibodies when given six months after the second dose.

The companies plan to submit this data to the FDA "in the coming weeks" for licensing. In this regard, the US media The Hill recalls that some scientists have warned that vaccine manufacturers are finding financial incentives to develop booster drugs and for the government to invest in more doses.

And that US health officials have specified that it is not clear that a booster vaccine is needed.

Anthony Fauci, the US government's top infectious disease expert, reiterated Thursday that two shots of the Pfizer and Moderna vaccines protect even against the delta variant.

However, Pfizer provided data on the vaccine's performance in Israel.

"As seen in real-world data published by the Israeli Ministry of Health, the vaccine's efficacy in preventing infections and symptomatic disease has declined six months after vaccination, although efficacy in preventing severe disease remains high," Pfizer said.

"Based on the data (Israel) has to date, Pfizer and BioNTech believe that a third dose may be beneficial within six to 12 months after the second dose to maintain the highest levels of protection," said the companies, which are partners in the production of this vaccine.

Pfizer also explained that it is preparing to begin clinical trials of a modified vaccine specifically targeting the delta variant in August, if needed. At the same time, however, Pfizer said a third dose of the original vaccine might be a better option.

Following Pfizer's announcement, the FDA and the Centers for Disease Control and Prevention (CDC) issued a joint statement last night downplaying the need for a booster vaccine.

"Americans who have been fully vaccinated do not need a booster vaccine at this time," the agencies said, adding that they are engaged in a "rigorous, science-based process" to determine whether one will be needed.

The agencies again emphasised that current vaccine regimens are effective. "People who are fully vaccinated are protected from serious illness and death, including from variants currently circulating in the country, such as Delta," the agencies stressed.