Pfizer ( PFE Quick Quote PFE - Free Report) and partner BioNTech ( BNTX Quick Quote BNTX - Free Report) announced that the FDA has authorized their emergency authorization application (EUA) request for the use of a booster/third dose of their mRNA-based COVID-19 vaccine, Comirnaty in children aged between 5 years and 11 years. The expanded EUA authorizes the use of the booster dose in children at least five months after the second dose of the two-dose primary series.
Pfizer and BioNTech have evaluated 10-µg doses for use during primary vaccination as well as the booster dose, instead of 30-µg doses used for adults.
Please note that the expanded EUA to include a booster dose for children was based on data from a phase II/III study evaluating the safety and immunogenicity of a third dose of Comirnaty in 140 children who had already received a primary two-dose regimen of the vaccine. Data from a sub-analysis of 30 immune human sera from the study showed a 36-fold increase in neutralizing antibodies against the Omicron variant.
The immunogenicity data gathered from all study participants also showed a six-fold increase in neutralizing antibodies against the SARS-CoV-2 wild-type strain after receiving the booster dose of the vaccine.
Pfizer and BioNTech stated that more than 8 million children in the age group of 5 to 11 years have received the initial two-dose primary series of COVID-19 vaccination in the United States. Currently, Comirnaty is the only COVID-19 vaccine with a EUA for use in children as primary series as well as for a third dose. This may lead to Pfizer and BioNTech gaining the lion’s share of booster dose administrations among children who have received primary vaccination in the United States.
The recent increase in COVID-19 infection cases in some key cities in the United States may also lead to a rise in vaccination rates going forward, especially children. Although the original COVID-19 strain seemed to have majorly infected adults and had a mild impact on children, the Omicron variant infected a large number of children.
Following the EUA, Pfizer and BioNTech shares gained 1.3% and 5.7%, respectively, on May 17. However, Pfizer’s shares have declined 13.1% so far this year against the
industry’s rise of 3.4%. Image Source: Zacks Investment Research
Pfizer and BioNTech have previously gained FDA approval for the two-dose primary series of Comirnaty for use in individuals aged 16 years or older. A two-dose primary series as well as a booster dose of the COVID-19 vaccine is authorized for emergency use in adolescents aged 12 years to 15 years. Comirnaty is also the only available COVID-19 vaccine for U.S. individuals aged 12-15 years.
Apart from a COVID-19 vaccine, Pfizer has also developed an oral drug, Paxlovid, which is authorized to treat mild-to-moderate COVID-19 in adults and certain pediatric patients aged 12 years or older, who are at high risk of diseases progression. The oral COVID pill and the COVID-19 vaccine are driving the majority of Pfizer’s revenues. The Zacks Consensus Estimate for Pfizer’s top line is currently pegged at $106.25 billion, primarily driven by Comirnaty and Paxlovid sales. Pfizer expects approximately $54 billion from these two COVID-related products in 2022.
However, Pfizer’s Comirnaty and Paxlovid face competition from
Moderna’s ( MRNA Quick Quote MRNA - Free Report) Spikevax and Merck’s ( MRK Quick Quote MRK - Free Report) Lagevrio, respectively.
Moderna’s Spikevax is also approved as a COVID-19 vaccine for use in adults in the United States. Moderna has filed several EUA requests seeking expanded use of Spikevax and its booster doses in adolescents and children with the FDA. However, additional data related to the safety and immunogenicity of a lower dose in adolescents compared to the requested dose in the EUA is delaying the authorization. Moderna is planning to file data from a study evaluating the lower dose soon.
Merck received EUA for its oral COVID pill, Lagevrio, last year. Merck has developed the drug in collaboration with Ridgeback. However, Merck expects much lower sales from Lagevrio compared to Paxlovid, between $5.0 billion and $5.5 billion in 2022.
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