Company officials announce plans to seek approval for booster dose

Data published Wednesday ahead of peer review show the Pfizer-BioNTech Covid-19 vaccine, BNT162b2, continues to provide almost universal protection against severe disease 6 months after full vaccination.

Overall vaccine efficacy against laboratory-confirmed Covid-19 was 91% (95% CI, 89.0-93.2) 6 months after full vaccination among participants who took part in a large vaccine trial.

Vaccine efficacy against severe disease was 97% (95% CI, 80.3-99.9) at 6 months follow-up, according to the preliminary findings, published in the preprint medical research server medRxiv.

The data were collected before the emergence of the delta variant of the virus, which is now the dominant strain of SARS-CoV-2 circulating in the United States and many other countries.

Also on Wednesday, officials with Pfizer confirmed on a quarterly earnings call with reporters that the company plans to seek FDA approval for a booster dose of its mRNA vaccine within the next month, based on company data suggesting that a third dose conveys significant protection against the delta variant.

The data showed a 5-fold increase in titers against the delta variant a month after receiving a booster, third dose of the vaccine in 18 to 55-year-olds, and an 11-fold increase in titers following a booster dose in 65-to-85-year-olds.

Pfizer CEO Albert Bourla told reporters on the conference call that the company plans to submit the new data to the FDA by August 16.

Mike Dolsten, who is president of Worldwide Research and Development at Pfizer, said data also suggest waning protection against infection causing mild to moderate symptoms 6 to 8 months after receiving two doses of the vaccine.

“Fortunately, the protection against severe disease, hospitalization and fatal outcomes remains pretty high, but we do see some lowering, particularly in real-world evidence studies from Israel, we see some lowering in that protection in risk groups, such as older adults, immunocompromised,” he said.

On Thursday, health officials in Israel announced that adults over the age of 60 in that country will be eligible for booster doses of Covid-19, with a third dose given 5 months or more following full vaccination.

According to a report in the Washington Post, Israel’s 60-year-old Prime Minister Isaac Herzog will be the first person in the country to receive a booster, third dose of the mRNA vaccine on Friday morning.

The paper also reported that nursing homes throughout Israel were already preparing to administer the booster doses.

Data reported last week by Israel’s Ministry of Health suggest a sharp drop off in protection against SARS-CoV-2 infection in the months following vaccination, although the data showed continued strong protection against severe disease.

The BNT162b2 vaccine was found to be just 39% effective in preventing infection in late June and early July, compared with 95% effective from January to early April of this year, according to the Ministry of Health data.

Salynn Boyles, Contributing Writer, BreakingMED™

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