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FDA Approves Pfizer & Moderna's New COVID Booster Vaccines
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The FDA approved Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Moderna’s (MRNA - Free Report) updated mRNA vaccines to protect against the currently circulating strains of the COVID-19 virus.
Moderna and Pfizer’s updated mRNA vaccines are each approved for individuals 12 years of age and older and are authorized under emergency use for individuals 6 months through 11 years of age.
Pre-clinical/clinical data from studies on Moderna and Pfizer’s updated mRNA vaccines have shown improved neutralizing antibody responses against multiple circulating Omicron-related sub-lineages, including XBB.1.5, BA.2.86 (also called Pirola) and EG.5.1 (also called Eris).
Moderna and Pfizer’s mRNA vaccines have been updated to include a single component that corresponds to the Omicron variant XBB.1.5, as directed by the FDA in June. In the said month, XBB.1.5, a subvariant of Omicron, was the dominant variant. Now, the dominant strains are Pirola and Eris. However, the companies are confident that their updated vaccines can provide protection against Pirola and Eris, which closely match the XBB.1.5 subvariant.
Infection rates are once again climbing in the United States, with Pirola and Eris accounting for the majority of the cases.
Moderna and Pfizer have been manufacturing the updated vaccines at risk and believe they will be ready for commercial delivery of the updated vaccines for the 2023-2024 fall and winter season.
They expect the vaccines to be launched in pharmacies, hospitals and clinics across the United States once the U.S. Centers for Disease Control and Prevention (CDC) recommends the jab. The CDC’s Advisory Committee on Immunization Practices will meet on Sep 12 to provide recommendations on who should receive an updated vaccine.
Novavax (NVAX - Free Report) has also developed an updated protein-based non-mRNA COVID-19 vaccine to target XBB lineages. However, the FDA did not give a green signal to Novavax’s updated vaccine. Novavax’s stock was down almost 13% in response.
Novavax issued a press release stating that it is ready to distribute its updated vaccine for the fall season once it receives FDA approval and CDC recommendation.
Drugmakers are trying to promote the idea of people taking an updated COVID shot along with their annual flu vaccination. However, some experts feel the protection offered by these updated shots wanes over time and with a new variant superseding the older one. Sales of Pfizer, Moderna and Novavax suffered in 2022 and the first half of 2023 as demand for COVID vaccines declined. It remains to be seen if these new “boosters” provide some boost to their makers’ top lines.
Pfizer/BioNTech and Moderna’s regulatory filings seeking approval for the updated vaccines are also under review in Europe, with a decision anticipated in the coming weeks.
Image: Bigstock
FDA Approves Pfizer & Moderna's New COVID Booster Vaccines
The FDA approved Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Moderna’s (MRNA - Free Report) updated mRNA vaccines to protect against the currently circulating strains of the COVID-19 virus.
Moderna and Pfizer’s updated mRNA vaccines are each approved for individuals 12 years of age and older and are authorized under emergency use for individuals 6 months through 11 years of age.
Pre-clinical/clinical data from studies on Moderna and Pfizer’s updated mRNA vaccines have shown improved neutralizing antibody responses against multiple circulating Omicron-related sub-lineages, including XBB.1.5, BA.2.86 (also called Pirola) and EG.5.1 (also called Eris).
Moderna and Pfizer’s mRNA vaccines have been updated to include a single component that corresponds to the Omicron variant XBB.1.5, as directed by the FDA in June. In the said month, XBB.1.5, a subvariant of Omicron, was the dominant variant. Now, the dominant strains are Pirola and Eris. However, the companies are confident that their updated vaccines can provide protection against Pirola and Eris, which closely match the XBB.1.5 subvariant.
Infection rates are once again climbing in the United States, with Pirola and Eris accounting for the majority of the cases.
Moderna and Pfizer have been manufacturing the updated vaccines at risk and believe they will be ready for commercial delivery of the updated vaccines for the 2023-2024 fall and winter season.
They expect the vaccines to be launched in pharmacies, hospitals and clinics across the United States once the U.S. Centers for Disease Control and Prevention (CDC) recommends the jab. The CDC’s Advisory Committee on Immunization Practices will meet on Sep 12 to provide recommendations on who should receive an updated vaccine.
Novavax (NVAX - Free Report) has also developed an updated protein-based non-mRNA COVID-19 vaccine to target XBB lineages. However, the FDA did not give a green signal to Novavax’s updated vaccine. Novavax’s stock was down almost 13% in response.
Novavax issued a press release stating that it is ready to distribute its updated vaccine for the fall season once it receives FDA approval and CDC recommendation.
Drugmakers are trying to promote the idea of people taking an updated COVID shot along with their annual flu vaccination. However, some experts feel the protection offered by these updated shots wanes over time and with a new variant superseding the older one. Sales of Pfizer, Moderna and Novavax suffered in 2022 and the first half of 2023 as demand for COVID vaccines declined. It remains to be seen if these new “boosters” provide some boost to their makers’ top lines.
Pfizer/BioNTech and Moderna’s regulatory filings seeking approval for the updated vaccines are also under review in Europe, with a decision anticipated in the coming weeks.
Pfizer and Moderna have a Zacks Rank #3 (Hold) each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.