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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.

BioNTech (Nasdaq: BNTX) announced a visit by CEO Prof. Ugur Sahin to Israel on September 7, 2022, to discuss potential collaborations on pandemic preparedness and innovative medicine development. Meetings included officials from the Ministry of Economy and Industry and key academic leaders. The talks focused on establishing a research facility and leveraging Israeli technologies for vaccine production. Prof. Sahin lauded Israel's public health initiatives. The discussions were facilitated by various governmental bodies and are aimed at enhancing BioNTech's international partnerships.

Pfizer and BioNTech announced that their Omicron BA.1-adapted bivalent COVID-19 vaccine, combining mRNA for wild-type and Omicron BA.1 spike proteins, has received a positive recommendation for conditional marketing authorization by the EMA's CHMP. The booster dose (30 µg) has shown a favorable safety profile and improved immune response in clinical trials. The vaccine is poised for immediate shipment to support European vaccination campaigns. Additionally, an application for an Omicron BA.4/BA.5-adapted vaccine is under review.

Pfizer and BioNTech announced that the CHMP has recommended conditional marketing authorization for their Omicron BA.1-adapted bivalent COVID-19 vaccine for individuals 12 years and older. This 30-µg booster dose combines mRNA from the original vaccine and mRNA for the Omicron BA.1 variant. The vaccine demonstrated improved immunogenicity, showing a 9-fold increase in neutralizing titers against the Omicron strain compared to the original vaccine. If approved, doses will be available to EU member states within days, supporting upcoming vaccination campaigns.