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Pfizer Seeks to Amend EUA of COVID-19 Vaccine to Include Children
The expanded authorization would include the first two COVID-19 vaccine doses of a planned three-dose primary series in children six months to four years old.
Pfizer and BioNTech recently initiated a rolling submission seeking to amend FDA’s emergency use authorization of their COVID-19 vaccine to include children six months to four years of age.
The companies expect to complete the submission in the coming days. The authorization would include the first two three-microgram doses of a planned three-dose primary series in this age group. Novavax will submit data on the third dose at least eight weeks after completion to FDA as well.
Since March 2020, over 10.6 million children have tested positive for COVID-19 in the US, with children under four years old accounting for more than 1.6 million of those cases. If FDA grants authorization, the Pfizer-BioNTech vaccine will be the first available to help protect this age group.
“A hospitalizations of children under 5 due to COVID-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus,” Albert Bourla, chairman and CEO of Pfizer, said in the announcement.
“If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” Bourla continued.
The request to amend the authorization is based on the safety, tolerability, immunogenicity, and efficacy data of two doses of the Pfizer-BioNTech COVID-19 vaccine.
Pfizer and BioNTech will share these data with the European Medicines Agency and other regulatory agencies globally. Additionally, the companies will supply the three-microgram dose to meet demand if FDA approves the emergency use authorization expansion.
Merck Supplies 3.1M Courses of COVID-19 Treatment to US Govt
Merck and Ridgeback Biotherapeutics recently supplied 3.1 million courses of their COVID-19 treatment, molnupiravir, to the US government for distribution across the country.
HHS created a website to help providers identify locations that have received shipments of government-procured COVID-19 therapeutics available under FDA emergency use authorization.
So far, Merck has agreed to supply 3.1 million courses of molnupiravir to the government upon FDA authorization or approval and entered into advance purchase and supply agreements for molnupiravir in over 30 markets globally, including Australia, Canada, Korea, Thailand, Ukraine, and the UK.
Additionally, the company has shipped molnupiravir to over 25 countries.
“In line with our commitment to accelerating access to molnupiravir in the US, we have now supplied more than 3 million courses to the US government within approximately 7 weeks of receiving Emergency Use Authorization from the US Food and Drug Administration,” Robert M. Davis, chief executive officer and president of Merck, said in the announcement.
“I am grateful to our colleagues who have worked tirelessly over the past year to accomplish this goal and to the health care providers who remain on the front lines of caring for patients with COVID-19,” Davis continued.
New Zealand Approves Novavax’s COVID-19 Vaccine
New Zealand Medsafe recently granted provisional approval of Novavax’s COVID-19 vaccine, NVX-CoV2373, for adults aged 18 and older.
The approval is based on the evaluation of the quality, safety, and efficacy data submitted for review, including two pivotal Phase 3 clinical trials. The PREVENT-19 trial enrolled 30,000 participants in the US and Mexico, while the second trial enrolled nearly 15,000 participants in the UK.
The vaccine demonstrated high efficacy and a reassuring safety profile in both trials. Novavax will supply the vaccine to New Zealand under the brand name Nuvaxovid.
“The provisional approval of Nuvaxovid by Medsafe will enable Novavax to deliver the first protein-based COVID-19 vaccine to New Zealand,” Stanley C. Erck, president and CEO of Novavax, said in the announcement.
“We thank Medsafe for its thorough review and, as the pandemic continues to evolve, we remain committed to supporting New Zealand and the world in the fight against COVID-19,” Erck continued.
So far, Europe has granted conditional marketing authorization for NVX-CoV2373, the World Health Organization (WHO) granted emergency use listing, and Australia granted provisional registration.
