The latest on COVID-19 vaccines/drugs and manufacturing from Pfizer, Novavax, Merck & Co., and Daiichi Sankyo.

Updates on COVID-19 treatments and vaccines

Pfizer/BioNTech Seek OK for COVID-19 Vaccine in Children
Pfizer and BioNTech have initiated a rolling submission to the US Food and Drug Administration (FDA) seeking to amend the emergency use authorization (EUA) of their COVID-19 vaccine to include children six months through four years of age. The vaccine is already authorized for children age 5 to 11.

The companies expect to complete the EUA submission in the coming days (as reported on February 1, 2022). This application is for authorization of the first two 3-µg doses of a planned three-dose primary series in this age group. Data on a third dose given at least eight weeks after completion of the second dose are expected in the coming months (as reported on February 1, 2022) and will be submitted to the FDA to support a potential expansion of this requested EUA.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on February 15, 2022 to discuss the request for EUA of the vaccine for use in children six months through four years of age.

The FDA authorized the Pfizer’s/BioNTech’s COVID-19 vaccine for use in children five through 11 years of age in October 2021 and recently authorized the use of a single booster dose in individuals 12 through 15 years of age and older.

Source: Pfizer, BioNTech, and the US Food and Drug Administration  

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EMA Authorizes Pfizer’s COVID-19 Drug
The European Commission has granted conditional marketing authorization for Pfizer’s oral COVID-19 antiviral treatment, Paxlovid (nirmatrelvir and ritonavir). Paxlovid is now authorized across the European Union.  The European Commission granted conditional marketing authorization on January 28,2022 following a recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use.

The drug is authorized for treating COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of the disease becoming severe.

Source: European Medicines Agency

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Novavax Files for EUA for COVID-19 Vaccine in US
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has submitted a request to the US Food and Drug Administration (FDA) for emergency use authorization (EUA) for NVX-CoV2373, the company’s COVID-19 vaccine, individuals 18 year of age and older.

Separately, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorization for the vaccine in individuals 18 years of age and older. The vaccine will be marketed under the name Nuvaxovid in the UK.

Separately, Novavax has formed an advance purchasing agreement with Israel’s Ministry of Health for an initial 5 million doses of the vaccine with an option for Israel to purchase an additional 5 million doses. Novavax says it will work with the Ministry of Health to obtain the necessary authorizations and finalize plans for distribution in Israel pending regulatory approval.

Source: Novavax (US), Novavax (UK), and Novavax (Israel)

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Merck & Co. Reports Results of COVID-19 Drug on Omicron 
Merck & Co. reports results from in-vitro studies that suggest that molnupiravir, its oral COVID-19 antiviral medicine, is active against the SARS-CoV-2 variant Omicron.

The in-vitro studies were independently conducted by researchers from institutions in six countries, including Belgium, the Czech Republic, Germany, Poland, the Netherlands, and the US. The studies used established cell-based assays to evaluate the antiviral activity of molnupiravir and other COVID-19 antiviral agents against SARS-CoV-2 variants of concern, including Omicron. Molnupiravir has yet to be studied against the Omicron variant in clinical studies.

Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics, a Miami, Florida-based bio/pharmaceutical company. The drug has been authorized in more than 10 countries, including the US, UK, and Japan.

Source: Merck & Co.

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Daiichi Sankyo Initiates COVID-19 Vaccine Booster Trial 
Daiichi Sankyo has initiated a trial in Japan to investigate a booster dose of DS-5670, its mRNA COVID-19 vaccine.

The trial is being conducted as a Phase I/II/III study to evaluate DS-5670 in healthy Japanese adults, including the elderly, who completed initial vaccination (1st and 2nd shots) against COVID-19 with vaccines approved in Japan, six months after initial vaccination The first part of the study will determine the recommended booster dose of DS-5670 followed by a controlled study in 4,500 adults comparing DS-5670 to other vaccines approved in Japan.

Source: Daiichi Sankyo