COVID Vaccines: Company Announcements on Development/Regulatory Actions/Procurement/Deployment

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COVID Vaccines: Company Announcements on Development/Regulatory Actions/Procurement/Deployment

An In Vitro Study Shows Pfizer-BioNTech COVID-19 Vaccine Elicits Antibodies that Neutralize SARS-CoV-2 with a Mutation Associated with Rapid Transmission
New York, NY and Mainz, Germany, January 8, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE
(Nasdaq: BNTX) today announced results from an in vitro study conducted by Pfizer and the University of Texas Medical Branch (UTMB) that shows the antibodies from people who have received the Pfizer-BioNTech COVID-19 vaccine effectively neutralize SARS-CoV-2 with a key mutation that is also found in two highly transmissible strains. The results were published on the preprint server bioRxiv and are available here.

Rapidly spreading variants of SARS-CoV-2 have been reported, initially in the United Kingdom and South Africa. These variants have multiple mutations in their spike or S glycoproteins, which are key targets of virus neutralizing antibodies. Though these two rapidly spreading viruses are different, they share the N501Y mutation, which is located in the receptor binding site of the spike protein and results in the virus’s spike protein binding more tightly to its receptor. It has been shown to infect mice more efficiently.1

To determine if sera of people who had received the Pfizer-BioNTech COVID-19 vaccine could neutralize SARS-CoV-2 with the N501Y mutation, a virus with this substitution was generated in UTMB’s laboratory. The sera of 20 participants from the previously reported Phase 3 trial neutralized the virus with the mutation as well as they neutralized virus without the mutation.

While the virus tested in this experiment did not include the full set of spike mutations found on the rapidly spreading strains in the U.K. or South Africa, neutralization of virus with the N501Y mutation by the Pfizer- BioNTech vaccine-elicited human sera is consistent with preserved neutralization of a panel of 15 pseudoviruses bearing spikes with other mutations found in circulating SARS-CoV-2 strains. This indicates that the key N501Y mutation, which is found in the emerging U.K and South Africa variants, does not create resistance to the Pfizer-BioNTech vaccine induced immune responses.

Pfizer, BioNTech, and UTMB are encouraged by these early, in vitro study findings. Further data are needed to monitor the Pfizer-BioNTech COVID-19 vaccine’s effectiveness in preventing COVID-19 caused by new virus variants. If the virus mutates such that an update to the vaccine is required to continue to confer protection against COVID-19, we believe that the flexibility of BioNTech’s proprietary mRNA vaccine platform is well suited to enable an adjustment to the vaccine…

United Kingdom Medicines and Healthcare products Regulatory Agency Authorizes Use of COVID-19 Vaccine Moderna
January 08, 2021
:: UK MHRA authorization is based on a rolling review of COVID-19 Vaccine Moderna data, including data from the Phase 3 COVE study
:: UK government secured an additional 10 million doses for a total of 17 million doses of the vaccine with supply beginning in early 2021
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved its mRNA vaccine against COVID-19 (COVID-19 Vaccine Moderna) for use under Regulation 174. The temporary authorization permits the supply of COVID-19 Vaccine Moderna in Great Britain and is based upon the advice of the UK Commission on Human Medicines…

European Commission Authorizes COVID-19 Vaccine Moderna in Europe
January 06, 2021
:: Authorization follows European Medicines Agency recommendation of COVID-19 Vaccine Moderna
:: European Commission has secured 160 million doses; first deliveries to countries will begin next week
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Commission has granted a conditional marketing authorization (CMA) for COVID-19 Vaccine Moderna, allowing vaccination programs using the Moderna vaccine to be rolled out across the European Union. The authorization is based upon the recommendation of the European Medicines Agency (EMA) for use of the COVID-19 Vaccine Moderna for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older..

Israeli Ministry of Health Authorizes COVID-19 Vaccine Moderna for Use in Israel
January 04, 2021
Ministry of Health of Israel has secured 6 million doses and first deliveries expected to begin in January
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Israel’s Ministry of Health (MOH) has given authorization to import the COVID-19 Vaccine Moderna in Israel.
“Today’s authorization is a landmark moment in our company’s history and in the global fight against COVID-19,” said Stéphane Bancel, Chief Executive Officer of Moderna. “This is the third regulatory authorization for the COVID-19 Vaccine Moderna, and its first outside of North America…