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August 13, 2021

FDA authorises third Covid vaccine dose for immunocompromised people

The updated EUA permits the use of the third dose of the vaccines in this population after at least 28 days from the second dose.

The US Food and Drug Administration (FDA) has revised emergency use authorizations (EUAs) for the Pfizer-BioNTech and Moderna’s Covid-19 vaccines to enable the use of a third dose in some immunocompromised people.

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The additional dose is particularly intended for solid organ transplant recipients or those with conditions that are regarded to be on an equivalent immunocompromise level.

People whose immunocompromise is comparable to those who had solid organ transplantation have a low ability to fight diseases and infections, such as Covid-19.

The Pfizer-BioNTech’s Covid-19 vaccine is authorised for emergency use in people aged 12 or above, while Moderna’s Covid-19 vaccine is authorised for emergency use in adults aged 18 and over.

Both vaccines are given in a two-dose regimen, with the Pfizer-BioNTech jabs administered with a gap of three weeks and the Moderna shots given one month apart.

As per the updated EUA, a third dose of the vaccine can be administered to immunocompromised individuals, aged 18 years or above, not less than 28 days after the two doses of the same vaccine.

The FDA analysed data on the use of a third dose of both vaccines in immunocompromised people and decided that an additional dose could boost protection in this population.

Acting FDA Commissioner Janet Woodcock said: “After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines.

“Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from Covid-19.”

The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will hold talks on additional clinical recommendations concerning immunocompromised people.

The third dose is not currently authorised by the FDA for use in individuals who are not immunocompromised, the regulatory agency noted.

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COVID-19 continues to dominate headlines the world over. It has already affected our lives forever. The way we work, shop, eat, seek medical advice, and socialize will all be different in the future. Quite how different remains to be seen, but all industries must plan for multiple eventualities.  Faced with an explosion of conflicting information on how to plan and implement successful recovery strategies, decision-makers are in dire need of a single, reliable source of intelligence.   GlobalData’s COVID-19 Executive Briefing gives you access to unparalleled data and insights to successfully navigate the uncertain road to recovery across the world’s largest industries. Understand every aspect of this disruptive theme by delving into: 
  •  COVID-19 infection update, with statistics on the spread, testing by country, as well as the latest data on vaccines and therapeutic developments 
  • Economic impact overview, covering stock market indices, GDP, unemployment rates, policy responses & GlobalData’s economic recovery scorecards 
  • Sector developments, with access to sector insight summaries, cross-sector indices and the leaders and laggards in each industry vertical 
Whatever your company’s imminent strategic plans, the long-lasting impact of COVID-19 must not be overlooked. Find out how to futureproof your business operations – download our report today. 
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