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J&J Increases Access To Its COVID-19 Vaccine Through COVAX

In other COVID news, the Japanese govt purchases 1.6M courses of Merck’s COVID-19 treatment and Moderna asks the EU to expand its COVID-19 vaccine to children 6 to 11 years of age.

Johnson & Johnson recently entered into an agreement with the US government and Gavi, the Vaccine Alliance, to allow access to its single-shot COVID-19 vaccine through the COVAX Humanitarian Buffer.

The vaccine offered through COVAX will protect the world’s most vulnerable individuals. The first deliveries to the Buffer will begin in the coming days. 

“We believe our single-shot COVID-19 vaccine has a critical role to play in conflict zones and other humanitarian settings that can’t be reached by government vaccination campaigns, and we are proud to be part of this effort to protect the world’s most vulnerable people,” Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer, said in the announcement. 

The COVAX Humanitarian Buffer is designed to ensure that people in conflict zones or humanitarian settings can access COVID-19 vaccines, regardless of whether they live outside traditional government vaccination campaigns.

Governments and both national and international humanitarian agencies can apply to receive vaccine doses from the Buffer. And if applications are granted and doses allocated, the agencies can then carry out the vaccination campaign, a Johnson & Johnson spokesperson explained. 

The Inter-Agency Standing Committee, the longest-standing humanitarian coordination forum of the United Nations system, estimated that nearly 167 million people, including about 60 to 80 million people in areas outside the reach of health authorities, may not receive COVID-19 vaccines. 

Vaccinating individuals in the most vulnerable populations is crucial, as many of them lack access to other healthcare resources if they contract the disease. 

Japanese Govt Purchases 1.6M Courses Of Merck’s COVID-19 Treatment

The Japanese government recently purchased about 1.6 million courses of Merck and Ridgeback Biotherapeutics’ COVID-19 treatment, molnupiravir. 

Under the agreement, Merk will supply the doses to the Japanese government for $1.2 billion if molnupiravir receives authorization or approval from Japan’s Pharmaceuticals and Medical Devices Agency. 

Additionally, Merck has been investing to support the development and scale-up of production of molnupiravir and will produce about 10 million courses of treatment by the end of 2021, with at least 20 million courses anticipated in 2022. 

“We are proud to partner with the Japanese government on this agreement to accelerate access to molnupiravir to patients in Japan if it is authorized or approved. We believe that these government purchase agreements reflect confidence in molnupiravir’s clinical profile and the hope that molnupiravir may have a meaningful impact on efforts to address the pandemic,” Frank Clyburn, president of human health at Merck, said in the announcement. 

Last week, the UK authorized molnupiravir to treat mild-to-moderate COVID-19 in adults with at least one risk factor for developing serious illness. 

Merck has entered into supply and purchase agreements with governments of various other countries and is also in discussion with additional governments. 

Moderna Asks EU To Expand Authorization for COVID-19 Vaccine To Children

Moderna recently filed to expand the conditional marketing authorization (CMA) in Europe for its COVID-19 vaccine, mRNA-1273, to include children. 

The company asked the European Medicines Agency (EMA) to evaluate a 50 microgram two-dose series of its COVID-19 vaccine in children six to 11 years of age after its Phase 2/3 KidCOVE study showed that the vaccine was 100 percent effective two weeks after the first dose. 

Overall, mRNA-1273 was generally well-tolerated in both adolescents and adults. 

“We are pleased to announce the submission of this variation to the EMA for use of our COVID-19 vaccine in children ages 6-11 in the European Union. This marks our first submission for the use of our vaccine in this age group,” Stéphane Bancel, chief executive officer of Moderna, said in the announcement. 

“We are encouraged that the Moderna COVID-19 vaccine at the 50 µg dose level helped prevent SARS-CoV-2 infection in children,” Bancel continued.

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