metamorworks/istock via Getty Im
Gavi Secures 500M Doses of Moderna’s COVID-19 Vaccine for COVAX
Moderna's COVID-19 vaccine will be available for eligible patients, while Novavax expands its trial to include pediatric patients and Eli Lilly donates its COVID-19 therapy to India.
Gavi, the Vaccine Alliance, recently announced that it signed an advance purchase agreement with Moderna for 500 million doses of its mRNA COVID-19 vaccine.
The initial supply under the agreement, secured on behalf of the COVAX Facility, is for advanced market commitment (AMC)-eligible participants. There is also a potential to allocate and supply to self-financing participants in the future.
“We are very pleased to sign this new agreement with Moderna, giving COVAX Facility participants access to yet another highly efficacious vaccine,” Seth Berkley, MD, CEO of Gavi, said in the announcement.
“Expanding and having a diverse portfolio has always been a core goal for COVAX, and to remain adaptable in the face of this continually evolving pandemic – including the rising threat posed by new variants. This agreement is a further step in that direction,” Berkley continued.
Moderna’s vaccine is part of the COVAX research and development portfolio. Most recently, the vaccine received WHO Emergency Use Listing, which makes it eligible to be supplied to COVAX Facility participants.
Vaccine supply is expected to end at the end of 2021, with a total 34 million doses available this year and nearly 466 million doses available in 2022.
COVAX co-lead CEPI provided initial investment in COVID-19 Vaccine Moderna to support production of the first clinical trial materials, a Gavi spokesperson explained.
Richard Hatchett, CEO of CEPI, stated that the company’s early investment in Moderna’s vaccine development program helped to get the project started. Hatchett believes that the vaccine will play a “vital role” in the global control of COVID-19.
Novavax Announces Phase 3 Trial Expansion for its COVID-19 Vaccine
Novavax recently announced that it initiated a pediatric expansion of its Phase 3 clinical trial for its COVID-19 vaccine candidate, NVX-CoV2373.
The additional arm of the ongoing PREVENT-19 trial will evaluate the efficacy, safety, and immunogenicity of the vaccine in nearly 3,000 adolescents 12 to 17 years of age throughout 75 sites in the US.
Participants will receive either NVX-CoV2373 or a placebo in two doses, administered 21 days apart.
Researchers explained that a blinded crossover will begin six months after initial set of vaccinations to ensure that all trial participants receive active vaccine. Participants will also be assessed for up to two years following the second dose.
At the end of January, NVX-CoV2373 was 89.3 percent effective against the UK variant COVID-19 strain and 95.6 percent effective against the original COVID-19 strain found in Wuhan, China.
Gregory M. Glenn, MD, president of research and development at Novavax will release updates from the PREVENT-19 trial in the near future.
Eli Lilly and Company Accelerates its COVID-19 Therapy in India
Eli Lilly and Company recently announced that it is offering donations of its COVID-19 therapy, baricitinib, to the Indian government through Direct Relief.
Additionally, the company will work with local Indian pharmaceutical companies to provide royalty-free voluntary licensing agreements to boost the manufacturing and distribution of the medicine in India during COVID-19.
Nearly 400,000 baricitinib tablets are being made immediately available to the Indian government for eligible hospitalized COVID-19 patients in India. Eli Lilly and Company will work to increase the amount of donated product multifold over the coming weeks.
The company’s initiative comes days after it received permission for restricted emergency use from the Central Drugs Standard Control Organization, a division of Ministry of Health.
The emergency use allows care providers to administer baricitinib two milligrams and four milligrams in combination with remdesivir. Remdesivir was the first COVID-19 treatment to be FDA approved at the end of October, five months after it was authorized for emergency use.
The restricted emergency use for baricitinib in India is intended for suspected or laboratory confirmed COVID-19 in hospitalized adults requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation.
