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Pfizer and BioNTech have announced encouraging early results from a Phase 2/3 clinical trial of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. Following a 30-µg booster dose, participants exhibited a significant increase in neutralizing antibodies against the Omicron BA.4/BA.5 variants. Both younger and older adults demonstrated similar responses. Notably, the bivalent vaccine is expected to outperform the original vaccine in providing protection against these variants. The vaccine was well tolerated, with safety profiles resembling that of the original formulation. Additional data is forthcoming.
Pfizer and BioNTech have received Emergency Use Authorization (EUA) from the FDA for their 10-µg bivalent COVID-19 vaccine targeting the Omicron BA.4/BA.5 variants for children aged 5-11. This booster is intended to increase protection as the Omicron variant accounts for over 80% of COVID-19 cases in the U.S. The companies have manufactured millions of doses and will initiate shipping pending CDC recommendations. Clinical trials are also underway for younger children. The authorization is based on supportive safety and immunogenicity data from previous vaccine studies.
Pfizer and BioNTech announced that the FDA granted Emergency Use Authorization (EUA) for a 10-µg booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children aged 5 to 11. The CDC's recommendation is pending before shipping. This booster aims to enhance protection as Omicron subvariants dominate U.S. cases. A clinical trial is underway for younger children. The companies have also applied for regulatory approvals in Europe and plan global submissions. Eligible residents will receive vaccines for free under U.S. government provisions.
BioNTech has partnered with Australia's State of Victoria to establish an mRNA research and innovation center in Melbourne, enhancing translational research for innovative medicines. A BioNTainer facility for clinical-scale manufacturing of mRNA products will also be constructed. BioNTech aims to expand its clinical development efforts in Australia, targeting cancer product candidates including BNT211, alongside two Phase 2 candidates currently in trials. The partnership will promote mRNA technology accessibility and collaboration in the Asia-Pacific region.
Pfizer and BioNTech announced on September 26, 2022, the submission of a request to the U.S. FDA for Emergency Use Authorization (EUA) for a 10-µg booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine targeted at children aged 5 to 11. The request is bolstered by safety and immunogenicity data from previous vaccine trials. Additionally, a Phase 1/2/3 study has commenced to assess different dosing regimens in children aged 6 months to 11 years. A marketing authorization extension for the vaccine in the EU is also planned.
Pfizer (PFE) and BioNTech (BNTX) announced the submission of a request to the FDA for Emergency Use Authorization of a 10-µg booster dose of their bivalent COVID-19 vaccine targeting the Omicron BA.4/BA.5 variant for children aged 5-11. This request is backed by safety and immunogenicity data. Additionally, a Phase 1/2/3 study has been initiated to evaluate the vaccine's safety and immune response among children aged 6 months to 11 years. The companies also plan to submit a marketing authorization application to the EMA for the same age group.
BioNTech and Pfizer announced a significant advancement for their COVID-19 vaccine, COMIRNATY. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended converting the conditional Marketing Authorization (cMA) to a full Marketing Authorization (MA) for all existing indications and formulations. This includes the bivalent variants. Additionally, the CHMP supported a booster dose for children aged 5 to 11 years. The European Commission will make the final decision, pending review of the recommendation.
Pfizer and BioNTech have received a conditional marketing authorization recommendation from the EMA's CHMP for their Omicron BA.4/BA.5 bivalent COVID-19 vaccine. This vaccine combines 15-µg of mRNA from the original SARS-CoV-2 strain and 15-µg from the Omicron BA.4/BA.5 variants, targeting individuals aged 12 and older. Pending approval from the European Commission, the vaccine will be available for EU vaccination campaigns this fall, enhancing immunity against the Omicron variant. Previous studies showed a strong immune response and favorable safety profile for the vaccine.
Pfizer and BioNTech have received a conditional marketing authorization recommendation from the EMA's CHMP for their bivalent Omicron BA.4/BA.5 COVID-19 vaccine for individuals 12 years and older. The vaccine combines components targeting both the original SARS-CoV-2 and Omicron subvariants, designed to elicit a strong immune response. If approved by the European Commission, distribution will commence immediately to support EU vaccination efforts this fall. Previous data showed a superior immune response against Omicron subvariants compared to the existing vaccine.
BioNTech has reported positive follow-up results from its Phase 1/2 trial of BNT211, a CAR-T cell therapy targeting advanced solid tumors, including testicular cancer. The results showed a 57% overall response rate and an 85% disease control rate in testicular cancer patients treated with the higher dose after lymphodepletion. Notably, BNT211 has received Priority Medicines designation from the European Medicines Agency, emphasizing its potential as a treatment option. The safety profile remains manageable, with no serious adverse effects reported.