The latest on COVID-19 vaccines/drugs, manufacturing and testing from Moderna, Gavi, Fujifilm Toyama Chemical, Roche, Novavax, and Bavarian Nordic. Highlights below.

Manufacturing and supply of COVID-19 vaccines and drugs
* Moderna, Gavi Adjust COVID Vaccine Supply Pact for Low- & Middle-Income Countries
Updates on COVID-19 Vaccines and Therapeutics
* Fujifilm Toyama Chemical Ends Development of COVID-19 Drug
* Novavax Receives FDA OK for COVID Vaccine Booster in Adults
* Bavarian Nordic Reports Phase II Results for COVID-19 Vaccine
Testing
* Roche Gets FDA OK for COVID-19 Test

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Manufacturing and supply of COVID-19 vaccines and drugs

Moderna, Gavi Adjust COVID Vaccine Supply Pact for Low- & Middle-Income Countries
Moderna and Gavi, a global vaccine alliance, have mutually agreed to cancel remaining pending orders under their current COVID-19 vaccine supply agreement for 2022. Under the agreement, Moderna supplied nearly 70 million doses of COVID-19 vaccines to 92 low- and middle-income countries under the COVAX Advance Market Commitment, a mechanism under the COVAX Facility, a global initiative for equitable access to vaccines, in addition facilitating the donation of more than 100 million doses to these countries.

To ensure low- and middle-income countries have access to updated variant-specific COVID-19 vaccines, Gavi and Moderna will create a new framework enabling Gavi to purchase up to 100 million doses of the vaccine in 2023 on behalf of the COVAX Facility. All doses are offered at Moderna’s lowest-tiered price.

Source: Moderna

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Updates on COVID-19 Vaccines and Therapeutics

Fujifilm Toyama Chemical Ends Development of COVID-19 Drug
Fujifilm Toyama Chemical has discontinued the development of its anti-influenza drug, Avigan (favipiravir), for use as a therapeutic drug against COVID-19.

In 2021, Fujifilm Toyama Chemical began a Phase III clinical trial in Japan aimed at confirming Avigan’s efficacy to prevent the progression to severe symptoms in COVID-19 patients who have not yet been vaccinated. The enrollment was terminated in March 2022 following a change of circumstances, including improvement in the vaccination rate and the spread of the Omicron variants, which have lower symptom severity rates than conventional strains.

Subsequent analysis of clinical data from the trial has not shown significant results. Accordingly, the company has decided to discontinue further development on Avigan against COVID-19 and will withdraw its application to partially amend Avigan’s manufacturing and marketing approval in Japan for treating COVID-19.

Source: Fujifilm Toyama Chemical

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Novavax Receives FDA OK for COVID Vaccine Booster in Adults
The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Novavax’s COVID-19 vaccine, Adjuvanted (NVX-CoV2373) as a booster dose for adults following primary vaccination with an authorized or approved COVID-19 vaccine. The authorization for the booster applies to individuals 18 years or folder who have completed primary vaccination with an authorized or approved COVID-19 vaccine for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the vaccine because they would otherwise not receive a booster dose of a COVID-19 vaccine. The booster dose is to be given at least six months after primary vaccination.

The vaccine is also available for use as a booster in adults aged 18 and older in the European Union, Japan, Australia, New Zealand, Switzerland, and Israel. In the US, the FDA granted EUA for a two-dose primary series in adults aged 18 and older in July 2022 and for adolescents aged 12 through 17 in August 2022.

Source: Novavax

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Bavarian Nordic Reports Phase II Results for COVID-19 Vaccine
Bavarian Nordic, a Hellerup (near Copenhagen), Denmark-based vaccine company, has announced positive results of a six-month follow-up analysis from a Phase II clinical trial of ABNCoV2, a virus-like particle-based, non-adjuvanted COVID-19 booster vaccine candidate.

Previously reported results from the trial showed that vaccination with 100 ug of ABNCoV2 in 103 seropositive subjects was able to demonstrate a boosting effect, increasing the existing levels of SARS-CoV-2 neutralizing antibodies against both the Wuhan variant and variants of concern (Alpha, Beta, Delta and Omicron).

Six months post vaccination, neutralization titers were six times higher than pre-boost titers against the Wuhan variant and nearly 10 times higher than the pre-boost titers for the Omicron BA.1 variant. This company says this represented less than a 50% decline in the peak neutralizing titers after six months. Compared to the data published for mRNA vaccines, the antibody decay appears less sharp, indicating a potentially longer duration of protection across variants of concern, according to the company.

Source: Bavarian Nordic

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Testing

Roche Gets FDA OK for COVID-19 Test
The US Food and Drug Administration has granted 510(k) clearance, the approval mechanism for medical devices, to Roche’s cobas SARS-CoV-2 Qualitative PCR test for use on Roche’s cobas 6800 and cobas 8800 testing systems.

The test is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasal and nasopharyngeal samples from symptomatic patients who are suspected of having COVID-19 as determined by their healthcare provider.

The test has been available in the US under emergency use authorization since March 2020.

Source: Roche