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FDA Authorizes PFE & MRNA's COVID-19 Boosters for All Adults
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The FDA has expanded the emergency use authorization (“EUA”) that was previously granted to booster doses of mRNA-based COVID-19 vaccines of Moderna (MRNA - Free Report) and Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) . Moderna’s mRNA-1273 and Pfizer, BioNTech’s Comirnaty booster shots for COVID-19 can now be administered to all adults following completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. With these authorizations, the United States now has authorized booster doses of three COVID-19 vaccines for all adults. The third vaccine is Johnson & Johnson’s (JNJ - Free Report) single-shot COVID-19 vaccine, whose booster dose was authorized by the FDA last month for a similar population.
The extension of the EUA for booster doses of mRNA-1273 and Comirnaty to include all adults was based on the immune response data, following booster administration in clinical studies as well as additional real-world data. The FDA determined that the benefits of a single booster dose outweighed the risks of myocarditis and pericarditis observed in real-world data.
We note that booster doses of mRNA-1273 and Comirnaty were granted EUA earlier for use in people aged 65 years or older (elderly) and in adults aged 18 or older who are at high risk of severe COVID-19 or whose exposure to coronavirus puts them at risk of complications or severe illness. The booster doses of all three vaccines are also authorized for heterologous or mix-and-match administration, which will allow the administration of booster doses of any of the vaccines irrespective of the primary vaccination regimen.
The authorization to the booster doses of the vaccines all adults should help the upside momentum in COVID-19 vaccine sales to continue for each of these companies.
Pfizer and BioNTech’s Comirnaty
Pfizer and BioNTech’s Comirnaty is currently the only COVID-19 vaccine to have received “full” FDA approval for immunization of adults. The approval was granted by the FDA in August 2021. Pfizer and BioNTech’s vaccine is also authorized for emergency use in children aged 6 to 11 years as well as adolescents aged 12 years and above in the United States and Canada. It is also authorized for use in adolescents and adults in Europe.
Pfizer have garnered revenues of $24.3 billion in the first nine months from the sale of Comirnaty and is expected to end 2021 with total sales of approximately $36 billion. The early receipt of regulatory authorization for pediatrics and adolescents in the United States has likely helped Pfizer and BioNTech gain a lead in the COVID-19 vaccine space.
Pfizer expects to generate total sales of approximately $29 billion by delivering 1.7 billion doses of Comirnaty in 2022.
Moderna’s mRNA-1273
Moderna gained authorization for its COVID-19 vaccine for use in all adults in December 2020 in the United States. The company’s vaccine is authorized for adolescents and adults in Europe. The vaccine received full approval for the same in Canada earlier this month. However, the FDA has extended the review of Moderna’s EUA application to include adolescents in November and a decision is expected in January 2022.
Moderna’s mRNA-1273 generated sales of $10.7 billion in the first nine months of 2021. The vaccine is anticipated to generate $15 billion to $18 billion in 2021. However, certain factors including longer delivery lead times for international shipments led to the shifting of supply of some doses scheduled for 2021 to 2022, hurting its vaccine sales. Although these sales may get recovered next year, the impact remains to be seen.
Moderna has advance purchase agreements for initial doses worth approximately $17 billion along with options for additional doses worth approximately $3 billion for 2022. MRNA anticipates commercial booster market sales to be up to $2 billion in 2022.
Johnson & Johnson’s COVID-19 Vaccine
Johnson & Johnson received the first EUA from the FDA for the use of its single-shot COVID-19 vaccine in adults in February 2021. The booster dose of the vaccine from Johnson & Johnson was granted EUA by the FDA in October for use in adults following two months of primary vaccination with the same vaccine.
Johnson & Johnson’s booster dose is also authorized for use in adults who were immunized with the mRNA-based COVID-19 vaccine. JNJ’s vaccine has generated sales of $766 million since its authorization in February.
Image: Bigstock
FDA Authorizes PFE & MRNA's COVID-19 Boosters for All Adults
The FDA has expanded the emergency use authorization (“EUA”) that was previously granted to booster doses of mRNA-based COVID-19 vaccines of Moderna (MRNA - Free Report) and Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) . Moderna’s mRNA-1273 and Pfizer, BioNTech’s Comirnaty booster shots for COVID-19 can now be administered to all adults following completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. With these authorizations, the United States now has authorized booster doses of three COVID-19 vaccines for all adults. The third vaccine is Johnson & Johnson’s (JNJ - Free Report) single-shot COVID-19 vaccine, whose booster dose was authorized by the FDA last month for a similar population.
The extension of the EUA for booster doses of mRNA-1273 and Comirnaty to include all adults was based on the immune response data, following booster administration in clinical studies as well as additional real-world data. The FDA determined that the benefits of a single booster dose outweighed the risks of myocarditis and pericarditis observed in real-world data.
We note that booster doses of mRNA-1273 and Comirnaty were granted EUA earlier for use in people aged 65 years or older (elderly) and in adults aged 18 or older who are at high risk of severe COVID-19 or whose exposure to coronavirus puts them at risk of complications or severe illness. The booster doses of all three vaccines are also authorized for heterologous or mix-and-match administration, which will allow the administration of booster doses of any of the vaccines irrespective of the primary vaccination regimen.
The authorization to the booster doses of the vaccines all adults should help the upside momentum in COVID-19 vaccine sales to continue for each of these companies.
Pfizer and BioNTech’s Comirnaty
Pfizer and BioNTech’s Comirnaty is currently the only COVID-19 vaccine to have received “full” FDA approval for immunization of adults. The approval was granted by the FDA in August 2021. Pfizer and BioNTech’s vaccine is also authorized for emergency use in children aged 6 to 11 years as well as adolescents aged 12 years and above in the United States and Canada. It is also authorized for use in adolescents and adults in Europe.
Pfizer have garnered revenues of $24.3 billion in the first nine months from the sale of Comirnaty and is expected to end 2021 with total sales of approximately $36 billion. The early receipt of regulatory authorization for pediatrics and adolescents in the United States has likely helped Pfizer and BioNTech gain a lead in the COVID-19 vaccine space.
Pfizer expects to generate total sales of approximately $29 billion by delivering 1.7 billion doses of Comirnaty in 2022.
Moderna’s mRNA-1273
Moderna gained authorization for its COVID-19 vaccine for use in all adults in December 2020 in the United States. The company’s vaccine is authorized for adolescents and adults in Europe. The vaccine received full approval for the same in Canada earlier this month. However, the FDA has extended the review of Moderna’s EUA application to include adolescents in November and a decision is expected in January 2022.
Moderna’s mRNA-1273 generated sales of $10.7 billion in the first nine months of 2021. The vaccine is anticipated to generate $15 billion to $18 billion in 2021. However, certain factors including longer delivery lead times for international shipments led to the shifting of supply of some doses scheduled for 2021 to 2022, hurting its vaccine sales. Although these sales may get recovered next year, the impact remains to be seen.
Moderna has advance purchase agreements for initial doses worth approximately $17 billion along with options for additional doses worth approximately $3 billion for 2022. MRNA anticipates commercial booster market sales to be up to $2 billion in 2022.
Johnson & Johnson’s COVID-19 Vaccine
Johnson & Johnson received the first EUA from the FDA for the use of its single-shot COVID-19 vaccine in adults in February 2021. The booster dose of the vaccine from Johnson & Johnson was granted EUA by the FDA in October for use in adults following two months of primary vaccination with the same vaccine.
Johnson & Johnson’s booster dose is also authorized for use in adults who were immunized with the mRNA-based COVID-19 vaccine. JNJ’s vaccine has generated sales of $766 million since its authorization in February.
Pfizer, Moderna, BioNTech and J&J all carry a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.