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US Gov’t Purchases 10M Courses of Pfizer’s COVID-19 Antiviral
In other COVID news, AstraZeneca’s COVID-19 antibody reduced the risk of developing symptomatic virus by 83% and the EMA began evaluating Novavax’s application for its vaccine.
The US government recently purchased 10 million courses of Pfizer’s COVID-19 antiviral candidate, PAXLOVID.
Under the terms of the agreement, the government will acquire 10 million treatment courses of PAXLOVID beginning later this year and concluding in 2022 for a total of $5.29 billion, contingent upon regulatory authorization.
If FDA approves or authorizes the antiviral, it will be the first 3CL protease inhibitor specifically designed to combat SARS-CoV-2.
Pfizer also entered into advanced purchase agreements with other countries and initiated bilateral outreach to nearly 100 countries globally.
“It is encouraging to see a growing understanding of the valuable role that oral investigational therapies may play in combatting COVID-19, and we look forward to continuing discussions with governments around the world to help ensure broad access for people everywhere,” Albert Bourla, chairman and CEO of Pfizer, said in the announcement.
Last week, Pfizer announced that PAXLOVID reduced hospitalization and death in high-risk adults with COVID-19 by 89 percent compared to placebo.
If FDA authorized or approved, healthcare providers will administer 300 milligrams of PAXLOVID with one 100 milligram tablet of ritonavir, given twice daily for five days.
AstraZeneca’s COVID-19 Antibody Effective in Phase 3 Trials
AstraZeneca recently announced that its COVID-19 antibody, AZD7442, showed robust efficacy in two Phase 3 trials, PROVENT and TACKLE.
The PROVENT trial administered 300 milligrams IM dose of AZD7442 and found that the antibody reduced the risk of developing symptomatic COVID-19 compared to placebo by 83 percent.
The PROVENT trial is the first Phase 3 trial designed to evaluate a monoclonal antibody for pre-exposure prophylaxis of symptomatic virus. About 75 percent of participants in the trial had comorbidities that put them at high risk for severe disease.
In the TACKLE trial, a 600 milligram IM dose of AZD7442 reduced the risk of developing severe disease or death by 88 percent compared to a placebo in symptomatic patients.
About 90 percent of participants enrolled in this trial were from high-risk populations.
“These new data add to the growing body of evidence supporting AZD7442’s potential to make a significant difference in the prevention and treatment of COVID-19. We are progressing regulatory filings around the world and look forward to providing an important new option against SARS-CoV-2 as quickly as possible,” Mene Pangalos, executive vice president of biopharmaceutics research and development at AstraZeneca, said in the announcement.
The EMA Begins Evaluation of Novavax’s COVID-19 Vaccine
The European Medicines Agency (EMA) recently began evaluating Novavax’s conditional marketing authorization (CMA) application for its COVID-19 vaccine.
In early November, Novavax completed the submission of all data required for regulatory evaluation of its vaccine, known as NVX-CoV2373 in the US and to be marketed as Nuvaxovid in the EU.
“Today’s announcement from EMA brings Novavax another step closer to our goal of ensuring broad global access to our protein-based COVID-19 vaccine across Europe,” Stanley C. Erck, president and chief executive officer of Novavax, said in the announcement.
“Novavax looks forward to providing an additional vaccine option in Europe, built on a proven, well-understood technology platform, and thanks the European Commission for its ongoing partnership and confidence in our COVID-19 program,” Erck continued.
EMA stated that it will accelerate the assessment of the vaccine, with an opinion potentially issued within the next few weeks.
So far, Novavax’s COVID-19 vaccine has received emergency use authorization in Indonesia and the Philippines. The company also filed for authorization in India and emergency use listing with the World Health Organization.
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