The Food and Drug Administration (FDA) on June 30 recommended that vaccine manufacturers add a SARS-CoV-2 omicron component to the current vaccine composition to create a bivalent, or two-component, booster vaccine that could be used this fall.
The agency urges manufacturers to add to the current vaccine composition an omicron BA.4/5 spike protein component to respond to emerging subvariants of concern. Because a primary vaccination series with existing COVID-19 vaccines authorized and approved by the FDA provides protection against serious outcomes of COVID-19 caused by circulating SARS-CoV-2 strains, the agency does not encourage manufacturers to change the vaccine dose for a primary vaccination series, only for booster doses.
The Department of Health and Human Services (HHS) on June 29 announced plans to purchase 105 million doses of Pfizer’s COVID-19 vaccine for a fall vaccination campaign. The $3.2 billion agreement comprises a combination of adult and pediatric doses; notably, a portion of the adult doses are provided as single-dose vials, a first for COVID-19 vaccines. The contract could include omicron-specific booster vaccines, pending FDA authorization, and also includes an option to purchase up to 195 million additional doses, for a total of 300 million doses. HHS anticipates receiving the first vaccine deliveries in early fall.
Pfizer Seeks FDA Approval for Paxlovid
Pfizer on June 30 applied for FDA approval of Paxlovid, an antiviral pill for patients who are at high risk of progressing to severe illness from COVID-19. FDA granted Paxlovid emergency use authorization (EUA) in December 2021.
Pfizer’s new drug application includes results from the Phase 2/3 EPIC-HR (Evaluation of Inhibition for COVID-19 in High-Risk Patients) study. Compared with a placebo, treatment with Paxlovid reduced by 88 percent the risk of hospitalization or death from any cause in non-hospitalized, high-risk adult patients treated within five days of symptom onset.
The submission also includes analyses from the Phase 2/3 EPIC-SR (Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients) study. This study included data from both vaccinated patients with risk factors for severe COVID-19 and unvaccinated patients without risk factors for severe COVID-19. Although this study did not meet the novel primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days, the data supported observations from EPIC-HR for use in patients with a high risk of progression to severe COVID-19 illness.
FDA Extends Shelf-Life for COVID-19 Treatments
FDA and the Assistant Secretary for Preparedness and Response (ASPR) on June 28 authorized an extension to the shelf life for specific lots of AstraZeneca’s monoclonal antibody, Evusheld (tixagevimab co-packaged with cilgavimab).
In December 2021, FDA authorized Evusheld for pre-exposure prevention in immunocompromised individuals; the agency revised the initial dose in February 2022 and updated the authorization in May 2022 to reflect new information on hypersensitivity reactions. The revised EUA extends the shelf life for select lots from 18 to 24 months. FDA issued an updated fact sheet for health care providers and letter of authorization for Evusheld.
The FDA on June 27 authorized an extension to the shelf life from 24 to 30 months for specific lots of the Regeneron monoclonal antibodies, casirivimab and imdevimab, administered together or REGEN-COV. Because of the high frequency of the omicron SARS-CoV-2 variant, against which REGEN-COV is not effective, REGEN-COV currently is not authorized for use in the United States. HHS has recommended that health care providers retain REGEN-COV in the event that future virus variants susceptible to the treatment begin circulating.
Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.
Contact Senior Director of Policy Erin O’Malley at email@example.com or 202.585.0127 with questions.