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US FDA expands COVID-19 booster jabs to all adults

All Americans 18 and over are now eligible to receive a booster shot of either the Pfizer/BioNTech or Moderna COVID-19 vaccines

FDA

The Food and Drug Administration (FDA) has amended the emergency use authorisations (EUAs) for both the Moderna and Pfizer/BioNTech COVID-19 vaccines to permit a booster dose to be given for all US adults.

Previously, only people aged 65 and over and younger people at high risk of severe disease or frequent institutional or occupational exposure to the virus were eligible for a booster dose. Now, all adults can receive a booster shot six months after a second dose of the Moderna or Pfizer/BioNTech vaccine or two months after the Janssen vaccine.

The decision was welcomed by President Biden, who said: “Today, the FDA and CDC concluded that all adults in America are now eligible for a COVID-19 booster shot. It’s a major step forward to accelerate our path out of the pandemic. You can get your booster and enjoy the holiday season knowing you have the highest level of protection.”

The FDA did not consult its vaccines advisory committee as the expansion of the booster authorisation did not ‘raise questions that would benefit from additional discussion by committee members’.

“Throughout the course of the COVID-19 pandemic, the FDA has worked to make timely public health decisions as the pandemic evolves,” said acting FDA commissioner Dr Janet Woodcock. “COVID-19 vaccines have proven to be the best and highly effective defence against COVID-19. Authorising the use of a single booster dose of either the Moderna or Pfizer/BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalisation and death.”

The FDA decision was immediately rubber-stamped by a unanimous vote of the Centers for Disease Control’s Advisory Committee on Immunization Practices (ACIP).

CDC director Dr Rochelle Walensky said: “After critical scientific evaluation, today’s unanimous decision carefully considered the current state of the pandemic, the latest vaccine effectiveness data over time, and review of safety data from people who have already received a COVID-19 primary vaccine series and booster. Booster shots have demonstrated the ability to safely increase people’s protection against infection and severe outcomes.

“Based on the compelling evidence, all adults over 18 should now have equitable access to a COVID-19 booster dose,” she added.

The CDC also encouraged the 47 million adults in the US who are not yet vaccinated to do so in order ‘to protect themselves, their families, loved ones and communities’.

Article by
Hugh Gosling

23rd November 2021

From: Regulatory

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