U.S. FDA gives green light to Moderna and J&J booster doses
Drug Approval

U.S. FDA gives green light to Moderna and J&J booster doses

The authority also allowed mix and match of booster doses once the primary vaccine has been administered.

  • By IPP Bureau | October 21, 2021

The U.S. Food and Drug Administration (FDA), has given the green signal for Covid-19 booster doses to be administered to eligible groups. Those approved are booster shots manufactured by Moderna and Johnson & Johnson. The U.S FDA also approved the administration of a mix and match booster dose.

The use of a single booster dose of the Moderna Covid-19 vaccine that may be administered at least 6 months after completion of the primary series to individuals 65 years of age and older. Second, 18 through 64 years of age at high risk of severe Covid-19 and third 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.

In the case of Janssen (Johnson & Johnson), the vaccine may be administered at least 2 months after completion of the single-dose primary regimen to individuals 18 years of age and older.

Finally, on the mix and match booster doses, The release said that the use of each of the available Covid-19 vaccines as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different available Covid-19 vaccine. To clarify that a single booster dose of the Pfizer-BioNTech Covid-19 vaccine may be administered at least 6 months after completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.

Today’s actions demonstrate our commitment to public health in proactively fighting against the Covid-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D. “As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent Covid-19, including the most serious consequences of the disease, such as hospitalisation and death. The available data suggest waning immunity in some populations who are fully vaccinated. The availability of these authorized boosters is important for continued protection against COVID-19 disease.”

“The amendments to the emergency use authorizations to include a single booster dose in eligible populations are based on the available data and information and follows the input from the members of our advisory committee who were supportive of the use of a booster dose of these vaccines in eligible populations,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “

 

 

 

 

 

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