Pittsburgh Post-Gazette

• Third shot greatly increases COVID-19 anitbodies, Pfizer study finds,

- By Sharon LaFraniere and Carl Zimmer

Pfizer and BioNTech said Wednesday they were now applying to the Food and Drug Administra­tion for supplement­al approval of a coronaviru­s vaccine booster shot for those aged 16 and older, and will submit all their supporting data by the end of this week. The move came as the companies said that a third shot of the vaccine sharply increased the levels of antibodies against the virus.

The companies conducted a study of 306 volunteers who received a booster shot about five to eight months after their second shot. Researcher­s found that the level of antibodies that block the coronaviru­s jumped more than 3 times higher than the level after the second dose.

The side effects of a third injection were about the same as after the initial two doses, the companies said. The underlying data was not included in the news release, nor were the dates or location of the study specified. The companies said they were preparing a scientific publicatio­n describing the research.

The news of Pfizer and BioNTech’s booster applicatio­n came two days after the FDA fully approved their two-dose vaccine for those 16 and older, making it the first to move beyond emergency use status.

Over the past few weeks, federal regulators have been racing to collect and evaluate data on booster shots. If the FDA decides additional shots are safe and effective, the Biden administra­tion has said it wants adults to get a third injection eight months after their second shot of the Pfizer or Moderna vaccines, starting the week of Sept. 20.

Federal health officials said last week that they believe that the potency of the Pfizer-BioNTech and Moderna vaccines wanes over time, raising the risk of infection from the highly contagious delta variant. While data indicates the vaccines continue to offer robust protection against hospitaliz­ation and severe disease, the officials said they fear that the situation could change without booster shots.

Some public health experts have challenged the plan as premature, saying the available data shows that the vaccines are holding up well against severe disease and hospitaliz­ation, including against the delta variant. Extra shots would be warranted only if the vaccines failed to meet that standard, some have said.

Pfizer executives presented an early look at their booster data July 23, during their second-quarter earnings call. In a smaller study, they found that antibody levels dropped markedly in the months following a second dose. But those levels jumped back up after a third dose. When researcher­s expanded their focus to a larger group of subjects, they continued to find a strong effect from the boosters.

Antibodies that can neutralize the coronaviru­s are only one kind of defense our immune systems use to fight it. The new study did not include details about other defenses provoked by the vaccine, such as immune cells trained to kill infected cells.

The participan­ts in the new booster study were between the ages of 18 and 55. It was not immediatel­y clear why the study did not include older people.

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