Research Roundup: Pfizer cold storage requirements relaxed, Sanofi/GSK vaccine shows promise in phase 2, and US commits to share vaccine doses
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On Wednesday, the US Food and Drug Administration (FDA) announced the Pfizer/BioNTech COVID-19 vaccine can be safely stored at refrigerator temperatures for up to a month, an expansion from the previous five-day limit. The authorization followed Pfizer’s submission of data to the agency supporting extended refrigerator storage of undiluted, thawed vials. The European Medicines Agency also authorized the change last week. The relaxed storage requirement should lead to more widespread availability of the vaccine by facilitating the ability of vaccine providers, such as community doctors’ offices, to receive, store, and administer the vaccine, according to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
The Sanofi/GlaxoSmithKline (GSK) COVID-19 vaccine candidate generated strong levels of neutralizing antibodies in recipients across all ages studied, according to phase 2 trial results announced by the companies last week. No safety or tolerability concerns arose in the trial. The two-dose vaccine is a recombinant protein vaccine and does not require an elaborate cold chain for storage and distribution. Sanofi and GSK also noted that high neutralizing antibody levels were generated after a single dose in participants with evidence of prior SARS-CoV-2 infection, which could suggest its value also as a booster used after an initial vaccination series. A large, international phase 3 trial is set to begin in the coming weeks, and the companies also plan to conduct studies targeting various variants of concern.
The United States committed to sending an additional 20 million COVID-19 vaccine doses to other countries last week, following an initial announcement that it would share 60 million doses of the AstraZeneca vaccine, which has not yet been authorized by the FDA. In Monday’s announcement, the Biden administration committed to sharing surplus supplies of the FDA-authorized Pfizer, Moderna, and Johnson & Johnson vaccines, in addition to the AstraZeneca vaccine doses, for a total of 80 million doses sent overseas in the next six weeks. Currently, only 0.3 percent of all COVID-19 vaccine doses administered worldwide have been given in low-income countries.