Pfizer Submits for EUA of Additional COVID-19 Vaccine Booster

March 24, 2022 - Pfizer and BioNTech recently submitted an application to FDA for emergency use authorization (EUA) of an additional COVID-19 vaccine booster dose for adults 65 years and older.  

The companies based their submission on two real-world data sets, which showed that an additional mRNA booster increases immunogenicity and lowers infections and severe illness rates.  

Experts analyzed the Israeli Ministry of Health records of over 1.1 million adults 60 years of age and older with no known history of SARS-CoV-2 infection and who are eligible for an additional (fourth dose) booster. 

Data showed rates of confirmed infections were two times lower and rates of severe illness were four times lower among individuals who received an additional booster dose of the vaccine compared to those who received one booster dose.  

Additionally, submission included results from an ongoing, open-label clinical trial in healthcare workers 18 years and older in Israel vaccinated with three doses of the Pfizer-BioNTech COVID-19 vaccine. 

Among 154 participants who received a fourth dose of the COVID-19 vaccine at least four months following the initial booster, neutralizing antibody titers increased nearly 7-fold to 8-fold at two and three weeks compared to five months after the third dose.  

There was also an 8-fold and 10-fold increase in neutralizing antibody titers against the Omicron variant at one and two weeks after the additional booster dose, respectively, compared to five months after the initial booster. 

In August 2021, FDA granted full approval to Pfizer and BioNTech's COVID-19 vaccine for individuals 16 years of age and older. Comirnaty was the first COVID-19 vaccine to be fully FDA approved.  

Roche Launches Molecular Testing Solutions to Identify SARS-CoV-2 Variants  

Roche and TIB Molbiol, a subsidiary within the Roche Diagnostics division, recently launched testing solutions that identify the SARS-CoV-2 B.1.1. 529 variant differentiates between the Omicron subvariants BA.1, BA.1.1, BA.2, BA.2.2, BA.3, and Delta.  

The available research-use-only tests, VirSNiP SARS-CoV-2 Spike S371LS373P and VirSNiP SARS-CoV-2 Spike S371LS373P452R, add to the test kits Roche and TIB Molbiol previously developed to detect BA.1 and BA.2 and other mutations in the Omicron variants.  

TIB Molbiol's researchers collaborate with academic contacts to continuously screen for new variants and emerging diseases. In January 2020, both companies provided the first research- use-only SARS-CoV-2 detection test.  

"In addition to detecting SARS-CoV-2, irrespective of the variants, we are able to provide testing solutions identifying and differentiating between BA.1, BA.1.1, BA.2, BA.2.2, BA.3, and Delta," Thomas Schinecker, CEO of Roche Diagnostics, said in the announcement.  

"It's critical to quickly and accurately identify variants to inform ongoing research,  - including the ongoing development of therapeutics and vaccines. This can potentially stop or slow down the advancement of the disease," Schinecker concluded.  

Moderna to Provide Switzerland With Additional 7 Million Doses of COVID-19 Vaccine  

Moderna recently entered into an agreement with the Swiss Federal Government to provide seven million doses of its COVID-19 booster vaccine in 2023. 

The anticipated doses are in addition to the seven million doses of Moderna's booster vaccine, which are scheduled for supply to Switzerland in the second half of 2022. As part of the recent agreement, Switzerland will have the option of seven million doses for delivery in 2023 and 2024.  

Last year, Swissmedic approved Spikevax for active immunization to COVID-19 in individuals 18 years of age and older. Recent studies showed that the vaccine demonstrated a high efficacy rate of 94% 14 days after the second vaccine injection. 

"We thank the Swiss Federal Government for their trust in our mRNA COVID-19 vaccine and for its leadership in preparing for an endemic setting in 2023 and 2024," Stéphane Bancel, CEO of Moderna, said in the announcement.  

"COVID-19 booster doses will continue to be instrumental in keeping infection rates down in our communities as we continue our fight against the pandemic," Bancel concluded.