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FDA Panel to Discuss Fourth Booster Dose in April Meeting
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On Monday, the FDA announced that it will hold an advisory committee meeting on Apr 6 to discuss the need for future boosters of authorized COVID-19 vaccines.
The agenda of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will be to discuss how the composition of present COVID-19 vaccines needs to be changed to address specific variants. The committee will also guide the FDA on when the COVID-19 vaccine booster doses should be given and to which age group. However, the committee members will not cast any vote at the meeting nor will they discuss any specific company’s vaccine applications.
Apart from the committee’s panel of expert scientific external advisors, representatives from the U.S. Centers for Disease Control and Prevention and the National Institutes of Health will also take part in the meeting
The news comes just days after Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Moderna (MRNA - Free Report) applied to the FDA to amend their existing Emergency Use Authorization (EUA) to allow an additional or the “fourth” booster dose of their COVID-19 vaccine. While Pfizer has applied for authorization in adults 65 years of age and older, Moderna is seeking authorization for all adults aged 18 years and above.
Per Moderna, the reason for seeking approval for the second booster dose in the 18 years and older age bracket is to provide flexibility for the healthcare authorities to determine the appropriate use of the second booster dose of its COVID-19 vaccine in relevant patient groups.
Pfizer and BioNTech and Moderna’s applications were based on safety and efficacy data from real-world studies from Israel when the Omicron variant was widely prevalent. Pfizer/BioNTech said that data from these studies showed that in individuals who were given the fourth shot, the rates of infections were two times lower and rates of severe illness were four times lower compared to those who only received the third booster shot.
Pfizer and BioNTech’s booster dose or “third dose” has been granted EUA for all adults 18 years of age and older, following the completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. Later, the EUA was extended to allow its use in individuals 16 and 17 years of age and thereafter in adolescents 12 to 15 years of age.
A booster dose of Moderna’s vaccine has been granted EUA for use in all adults in the United States at least six months after the completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine.
The rising infection rates in China and Europe due to BA.2, the Omicron subvariant and the emergence of a new variant Deltacron, a hybrid of the Omicron and Delta variants, in the United States and Europe, have triggered fresh concerns of a possible new wave of infections.
For individuals to be adequately protected, additional booster doses of COVID vaccines are needed as the immunity offered by the third dose eventually fades three to six months after receiving it. However, the need for additional booster doses for young healthy people has been frequently debated.
The VRBPAC meeting will likely give an insight into how the regulatory agency feels about the need for boosters.
Image: Bigstock
FDA Panel to Discuss Fourth Booster Dose in April Meeting
On Monday, the FDA announced that it will hold an advisory committee meeting on Apr 6 to discuss the need for future boosters of authorized COVID-19 vaccines.
The agenda of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will be to discuss how the composition of present COVID-19 vaccines needs to be changed to address specific variants. The committee will also guide the FDA on when the COVID-19 vaccine booster doses should be given and to which age group. However, the committee members will not cast any vote at the meeting nor will they discuss any specific company’s vaccine applications.
Apart from the committee’s panel of expert scientific external advisors, representatives from the U.S. Centers for Disease Control and Prevention and the National Institutes of Health will also take part in the meeting
The news comes just days after Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Moderna (MRNA - Free Report) applied to the FDA to amend their existing Emergency Use Authorization (EUA) to allow an additional or the “fourth” booster dose of their COVID-19 vaccine. While Pfizer has applied for authorization in adults 65 years of age and older, Moderna is seeking authorization for all adults aged 18 years and above.
Per Moderna, the reason for seeking approval for the second booster dose in the 18 years and older age bracket is to provide flexibility for the healthcare authorities to determine the appropriate use of the second booster dose of its COVID-19 vaccine in relevant patient groups.
Pfizer and BioNTech and Moderna’s applications were based on safety and efficacy data from real-world studies from Israel when the Omicron variant was widely prevalent. Pfizer/BioNTech said that data from these studies showed that in individuals who were given the fourth shot, the rates of infections were two times lower and rates of severe illness were four times lower compared to those who only received the third booster shot.
Pfizer and BioNTech’s booster dose or “third dose” has been granted EUA for all adults 18 years of age and older, following the completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. Later, the EUA was extended to allow its use in individuals 16 and 17 years of age and thereafter in adolescents 12 to 15 years of age.
A booster dose of Moderna’s vaccine has been granted EUA for use in all adults in the United States at least six months after the completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine.
The rising infection rates in China and Europe due to BA.2, the Omicron subvariant and the emergence of a new variant Deltacron, a hybrid of the Omicron and Delta variants, in the United States and Europe, have triggered fresh concerns of a possible new wave of infections.
For individuals to be adequately protected, additional booster doses of COVID vaccines are needed as the immunity offered by the third dose eventually fades three to six months after receiving it. However, the need for additional booster doses for young healthy people has been frequently debated.
The VRBPAC meeting will likely give an insight into how the regulatory agency feels about the need for boosters.
Pfizer, Moderna and BioNTech have a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.