Pfizer to ask FDA to allow COVID vaccine booster dose as Delta variant rolls out by Reuters

By Michael Erman and Julie Steenhuysen

NEW YORK (Reuters) – Pfizer Inc. (NYSE 🙂 plans to ask U.S. regulators to allow a booster dose of the COVID-19 vaccine next month, the drug’s chief scientist said Thursday, based on evidence of a higher risk of vaccination and re-infection six months later. A highly contagious Delta variant. Pfizer scientific director Mikael Dolsten said the recent decline in vaccine effectiveness in Israel was due to infections in people who were vaccinated in January or February. The country’s Ministry of Health said the vaccine’s effectiveness in preventing infection and symptomatic disease 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 said, “the risk of re-infection is likely to weaken as antibodies are lost as expected.”

Pfizer did not release the full set of Israeli data on Thursday, but said it would be released soon.

“It’s a small data set, but I think it’s a straightforward trend: out of six months, considering that Delta is the most contagious variant we’ve seen, it can cause mild infections and illnesses,” Dolsten said.

Data provided by Pfizer in the U.S. showed erosion of the vaccine’s effectiveness in the mid-80s after six months, Dolsten said, against the varieties that were circulating in the spring.

He pointed out that data from Israel and the United Kingdom suggest that although antibody levels are declining, the vaccine remains at around 95% for serious diseases.

The vaccine developed with German partner BioNTech SE (NASDAQ 🙂 has shown 95% effectiveness in preventing symptomatic COVID-19 in a clinical trial conducted by companies last year.

Dolsten said the first data from the company’s research show that a third dose of booster produces antibody levels five to 10 times higher than after the second dose, suggesting that a third dose will provide promising protection.

He said they have already approached Pfizer in Europe and several other countries to discuss booster doses, and some may start administering them before potential US authorization.

Dolsten said he believes booster shots are especially important in older age groups.

Pfizer expects the COVID-19 vaccine to make a significant contribution to revenue over the years, with sales projected at $ 26 billion in 2021. Overall spending on COVID-19 vaccines and booster shots could be $ 157 billion by 2025, according to U.S. health data company IQVIA Holdings (NYSE :).

Dr. Eric Topol, a professor of molecular medicine and director of the Scripps Research Translational Institute in La Jolla, California, said the decision on antibody protection does not take into account the role of other important parts of the immune response, including memory B cells. can produce antibodies when the virus is in doubt.

“You need better tests to be able to confirm that. They’re not just neutralizing antibodies,” Topol said.

Pfizer will soon begin a placebo-controlled efficacy trial with 10,000 participants. Dolsten said the study will take place during the fall, which will not be completed until the company is presented to the Food and Drug Administration.

Dr. William Schaffner, an expert on vaccines at Vanderbilt University Medical Center, said that although Pfizer approves the use of its boosters by the FDA, that is only the first step. Boosters should be reviewed and recommended by counselors to the U.S. Centers for Disease Control and Prevention.

“It’s by no means automatic,” he said. Schaffner said in a real way that most of the public health bandwidth in the United States is still focused on encouraging Americans to take the first and second doses of the vaccine.

The FDA declined to comment on Pfizer’s plans.

As the booster will boost growing demand for vaccines, which is still untapped in the world, Dolsten said Pfizer is looking at ways to boost production.

It already aims to produce 3 billion doses this year and 4 billion doses next year. Dolsten did not want to predict how many doses the company could add, but said “we could go up to $ 22 billion on the 22nd.”

Pfizer has said before that people will probably need a booster dose. Some scientists have questioned when or when they will need them.

Dolsten also said they are designing a new version of the vaccine aimed at the Pfizer and BioNTech Delta variant, but said companies do not believe the current version should be replaced to address the variant.