COVID News: Pfizer, Gilead, Moderna & More
The latest on COVID-19 vaccines/drugs and manufacturing from Pfizer, Gilead, Moderna, Novavax, and Sinovac.
Manufacturing and supply of COVID-19 vaccines and drugs
US Gov’t To Expand Availability of Pfizer’s COVID-19 Drug
The US government has announced plans to expand the availability of Paxlovid (nirmatrelvir tablets and ritonavir tablets), Pfizer’s oral COVID-19 treatment, with a commitment to purchase 20 million treatment courses.
Since December 2021, the Administration has distributed COVID-19 oral antivirals, and in March (March 2022), as supply began to ramp up, President Biden announced the Test-to-Treat initiative to help make it easier for people at high risk of severe disease to quickly access oral antiviral treatments. The Test-to-Treat initiative creates additional locations where people can get a COVID-19 test, a visit with a medical provider, and, if needed, free oral antiviral pills—all in one visit.
In an April 26, 2022 statement, the Biden Administration announced new actions for the availability of these treatments, including: (1) nearly doubling the number of places oral antivirals are available; (2) launching federally supported Test-to-Treat sites; (3) providing more guidance and tools healthcare providers to understand and prescribe treatments; and (4) provide more communication on the availability of these treatments.
Oral antivirals for treating COVID-19 are available in about 20,000 locations across the US. The Biden Administration expects that oral antivirals will soon be available in more than 30,000 locations. The US Department of Health and Human Services is working with pharmacy partners to increase availability to up to 40,000 sites over the coming weeks (as reported on April 26, 2022).
Additionally, building on the current 2,200 Test-to-Treat sites in pharmacies and other clinical settings, the US government will work with states and jurisdictions to establish additional Test-to-Treat locations with federal support.
Source: US White House
Updates on COVID-19 treatments and vaccines
Gilead’s COVID-19 Drug Approved for Children Under 12
The US Food and Drug Administration (FDA) has approved a supplemental new drug application for Veklury (remdesivir), Gilead Sciences’ antiviral drug for treating COVID-19 to children under 12 years of age. According to the FDA, this approval makes Veklury the first approved COVID-19 treatment for children less than 12 years of age.
Source: Gilead Sciences and the US Food and Drug Administration
Pfizer/BioNTech Seek US OK for COVID-19 Vaccine Booster in Children
Pfizer and BioNTech have submitted an application to the US Food and Drug Administration (FDA) for emergency use authorization (EUA) of a 10-µg booster dose of their COVID-19 vaccine for children aged five through 11 years of age.
The companies also plan to submit data to the European Medicines Agency (EMA) and other regulatory agencies globally for authorization in the coming weeks (as reported on April 26, 2022).
Moderna Files for US OK of COVID-19 Vaccine in Children Under 6
Moderna has submitted to the US Food and Drug Administration a request for emergency use authorization (EUA) for its COVID-19 vaccine in children six months to under two years of age and two years of age to under six years of age
Similar requests are underway with international regulatory authorities. The requests are based on a 25-μg two-dose primary series of the vaccine.
The EUA submission for children ages six months to under six years will be complete next week (as reported on April 28, 2022). Moderna is also currently studying booster doses for all pediatric cohorts.
Source: Moderna
Novavax Initiates COVID-19 Vaccine Booster Study in Adolescents
Novavax, a Gaithersburg, Maryland-based vaccine company, has initiated a Phase III study to evaluate a booster of its COVID-19 vaccine in adolescents aged 12 through 17. The study will evaluate the safety and immunogenicity of a third dose of the vaccine among trial participants aged 12 through 17. Initial results are expected during the second half of 2022.
Source: Novavax
China OKs Sinovac’s Omicron COVID-19 Vaccine for Clinical Trial
Sinovac Biotech, a Beijing, China-based bio/pharmaceutical company, reports that its COVID-19 vaccine candidate for the Omicron variant has been approved for a clinical trial in China.
Source: Sinovac
