Pfizer seeks EUA for omicron booster for under-5 kids

Pfizer (NYSE: PFE) and its COVID-19 vaccine partner BioNTech (Nasdaq: BNTX) today announced they’ve submitted a EUA application with the FDA for an omicron COVID-19 booster for children under 5.

The companies are seeking authorization for their omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6 months through 4 years of age.

The U.S. is presently grappling with a “tripledemic” of COVID-19, flu and RSV, which can each cause respiratory distress in children. Pfizer and BioNTech said today that updated COVID-19 vaccines may help prevent severe illness and hospitalization.

If authorized, children in this age group would still receive a primary series consisting of two 3-µg doses of the original Pfizer-BioNTech COVID-19 vaccine. After that, they would receive a third 3-µg dose of the omicron BA.4/BA.5-adapted bivalent vaccine.

Pfizer and BioNTech are seeking a sim…

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Pfizer and BioNTech launch Phase 1 study of next-gen BNT162b4 COVID-19 vaccine

Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) have begun a Phase 1 study to investigate the next-generation BNT162b4 COVID-19 vaccine candidate that could potentially result in a stronger and more durable immune response.

Known as BNT162b4, the vaccine candidate has a T cell antigen mRNA encoding for SARS-CoV-2 non-spike proteins that are conserved across various variants.

The first-generation mRNA-based COVID-19 vaccines encoded the spike protein of the original SARS-CoV-2 virus. The second-generation mRNA-based boosters distributed in the U.S. encode both the spike protein from the original SARS-CoV-2 virus and the BA.4/BA.5 sub-variants.

Earlier this year, Mikael Dolsten, Pfizer’s president of worldwide R&D and medical, said the company aimed to “deliver a next-generation COVID-19 vaccine that can provide durable antibody and T cell immune protection against severe disease and hospitalization for at least one year.”


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Pfizer shares preliminary findings on omicron-adapted bivalent COVID-19 booster

Early data from a Pfizer-BioNTech (NYSE:PFE/Nasdaq:BNTX) Phase 2/3 study (NCT05472038) indicate that their updated omicron BA.4/BA.5-adapted bivalent COVID-19 booster works as intended. 

After drawing sera from booster recipients seven days after administration, investigators concluded that a single 30-µg booster dose increased omicron BA.4/BA.5 neutralizing antibody levels. In addition, they note that the updated vaccine potentially offers more robust protection against those omicron sub-lineages than the original vaccine in adults. 

The updated vaccine also appeared to be well tolerated, with a safety profile similar to the companies’ first COVID-19 vaccine. 

Pfizer and BioNTech will present additional data on the bivalent vaccine one month after administration in the coming weeks. 

The study broke participants into two age groups, with the first aged 18 to 55 years old and the second group older than 55. There were 40 volunteers in each age gro…

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Moderna says Pfizer-BioNTech COVID vaccine infringed its patents

Moderna (Nasdaq:MRNA) announced today that it is suing Pfizer and its COVID-19 vaccine partner BioNTech over patent infringement in U.S. and German courts.

Cambridge, Massachusetts–based Moderna said it is in the process of filing the complaints in U.S. District Court in Massachusetts and the Regional Court of Düsseldorf in Germany.

The suits could pit three of the most significant COVID-19 vaccine makers against each other in an IP battle with billions of dollars potentially at stake. COVID-19 vaccine revenue boosted Pfizer to the top of the list among the Pharma 50 largest pharmaceutical companies on Drug Discovery & Development. Moderna and BioNTech also joined the Pharma 50 for the first time in the most recent edition.

“We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the COVID-19 pandemic,” Moderna CEO…

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FDA allows booster dose Pfizer-BioNTech COVID-19 vaccine in children 5 to 11

The Pfizer-BioNTech vaccine booster had been previously limited in the U.S. to individuals at least 12 years old, but now children as young as 5 are eligible, thanks to an expanded emergency use authorization related to the vaccine.

The agency agreed to expand the vaccine’s use in children to “provide continued protection against COVID-19,” said FDA Commissioner Robert M. Califf in a news release.

While “COVID-19 tends to be less severe in children than adults,” Califf noted that the omicron wave has resulted in more children getting infected and hospitalized with COVID-19 infections. “Children may also experience longer-term effects, even following initially mild disease,” he added.

The FDA has determined that vaccine effectiveness in all authorized populations wanes in the weeks and months following administration of a second dose.

“The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID…

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