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Pfizer seeking FDA approval for COVID-19 vaccine booster dose

Drugmaker says it has started application for green light from US drug authority, a month after Israel started offering 3rd shot to wider population

An Israeli receives a coronavirus booster shot at a Maccabi Healthcare Services vaccination center, on August 1, 2021. (Yonatan Sindel/Flash90)
An Israeli receives a coronavirus booster shot at a Maccabi Healthcare Services vaccination center, on August 1, 2021. (Yonatan Sindel/Flash90)

AP — Pfizer is seeking United States approval of the booster dose of its two-shot COVID-19 vaccine.

The drugmaker said on Wednesday that it has started the application process for a third dose of its vaccine for everyone ages 16 and older. The company said that it will complete the application with the Food and Drug Administration by the end of this week.

The FDA earlier this month said that transplant recipients or others with weakened immune systems can get an extra dose of the Pfizer or Moderna vaccines. Then last week, US health officials announced plans to give COVID-19 booster shots to all Americans to shore up their protection amid the surging delta variant of the coronavirus.

That plan drew criticism from scientists at the World Health Organization, who noted that poor countries are not getting enough vaccines for their initial rounds of shots.

Israel became the first country to administer the booster shots to its wider population when it started offering them to people over the age of 60 on August 1. As of Tuesday, the third doses are open to all Israelis over age 30.

In total, more than 1.7 million Israelis have received a booster dose of the Pfizer vaccine so far.

A health worker administers a third dose of the Pfizer-BioNtech COVID-19 vaccine at a Maccabi Health Services clinic in Jerusalem, on August 20, 2021, after Israel approved booster shots for those over 40. (Ahmad Gharabli/AFP)

Pfizer’s vaccine, jointly developed with Germany’s BioNTech, received full FDA approval earlier this week, also for those aged 16 and older. It had previously been given to that age group under an emergency use authorization, which is still the case for those between the ages of 12 to 15.

More than 200 million doses of the Pfizer vaccine have been administered in the US — and hundreds of millions more worldwide — since it got the green light in December.

The three vaccines used in the US, made by Pfizer, Moderna and Johnson & Johnson, are still preventing hospitalizations and deaths from COVID-19. But the vaccines don’t appear to be quite as strong against the highly contagious delta variant as they were against earlier versions of the virus.

The US booster plan calls for an extra dose eight months after people get their second shot of the Pfizer or Moderna vaccine.

Israel is offering booster shots six months after the second vaccine dose.

Times of Israel staff contributed to this report.

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