An FDA analysis found that the single-dose COVID-19 vaccine candidate developed by Johnson & Johnson (NYSE:JNJ) is safe and effective. The analysis comes two days ahead of the FDA’s meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the EUA request for the vaccine. Johnson & Johnson submitted the EUA […]
COVID-19 vaccine
FDA issues guidelines to address COVID-19 variants
The FDA today issued guidance for medical product developers to address the emergence of variants of SARS-CoV-2, which causes COVID-19. Variants of the virus have been detected in multiple countries across the globe, including the U.S., and they pose a major threat to potentially ending the COVID-19 pandemic as protocols such as mask-wearing and hand-washing […]
Biden announces $4B to support global vaccinations worldwide
President Joe Biden announced that the U.S. is set to provide $4 billion to the COVAX Facility to support access to safe and effective COVID-19 vaccines. Money appropriated by a December 2020 Congressional vote will comprise an initial $2 billion contribution to Gavi, the Vaccine Alliance for the COVAX advance market commitment (AMC) covering 92 […]
J&J submits EUL application to WHO for single-shot COVID-19 vaccine
Johnson & Johnson (NYSE:JNJ) announced today that it submitted for emergency use listing (EUL) to the World Health Organization (WHO) for its COVID-19 vaccine. New Brunswick, N.J.-based J&J’s Janssen subsidiary’s single-dose COVID-19 vaccine candidate was submitted for EUL with a data package including interim efficacy and safety results from the Phase 3 Ensemble clinical trial, which […]
Pfizer, BioNTech start trial to evaluate COVID-19 vaccine’s effect on pregnant women
Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that it dosed the first participants in a trial of its COVID-19 vaccine for pregnant women. The companies, which developed one of the two COVID-19 vaccines to be authorized in the U.S. so far, are conducting a global Phase 2/3 study to evaluate the safety, tolerability and immunogenicity of the vaccine […]
J&J applies for COVID vaccine approval in Europe
Johnson & Johnson (NYSE:JNJ) announced today that it submitted a conditional marketing authorization application (cMAA) for its COVID-19 vaccine. New Brunswick, N.J.-based J&J’s cMAA application with the European Medicines Agency (EMA) is seeking authorization for the investigational, single-dose COVID-19 vaccine candidate developed by its Janssen subsidiary, according to a news release. The submission is based on […]
Feds order 200M more vaccine doses from Pfizer, Moderna
U.S. government agencies announced that they purchased a total of 200 million additional doses of COVID-19 vaccines from Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA). The orders of 100 million doses from each of the only two FDA-authorized vaccines in the U.S. were made by the U.S. Health & Human Services Dept. (HHS) and the Defense Dept. (DoD). The […]
J&J CEO says getting a COVID-19 vaccine could be an annual ritual for years
Johnson & Johnson (NYSE:JNJ) CEO Alex Gorsky said people may need COVID-19 vaccines annually, like flu shots, over the next several years. Speaking to CNBC, Gorsky cited the mutations and variants of the disease, several of which have already landed in the U.S., as the driving force behind differentiating capabilities of the vaccine to fight off antibodies. Previous […]
Report: Pfizer speeding up vaccine production
Pfizer (NYSE:PFE) is reportedly expecting to trim the time needed to produce COVID-19 vaccine batches to speed up production. The company, which along with BioNTech (NSDQ:BNTX) developed one of two COVID-19 vaccines currently authorized in the U.S., is slated to cut the amount of time it takes to produce a batch of the vaccine from 110 […]
South Africa pauses rollout of AstraZeneca COVID-19 vaccine
South Africa has scrapped its plans to vaccinate a portion of its population with the COVID-19 vaccine from Oxford University and AstraZeneca (LON:AZN) after a small study showed it was ineffective against a variant widely circulating there. In the interim, South Africa will rely on vaccines from Johnson & Johnson (NYSE:JNJ) and Pfizer (NYSE:PFE). Researchers at Oxford University […]
Feds to order 61M more at-home coronavirus tests, build surgical glove factories
Just days after ordering 8.5 million at-home tests from Ellume, the Biden administration announced today that it’s in talks with six other at-home coronavirus test manufacturers. In an online briefing, Tim Manning, the national supply chain coordinator for COVID response, told reporters that these companies could produce another 61 million at-home tests by the end of […]