150 Countries Sign Up For COVID-19 Vaccine Global Access Facility; Moderna Releases Promising Peer-Reviewed Phase I Vaccine Trial Results

Some 75 new countries have submitted expressions of interest to join the COVAX Facility, potentially supporting 90 other countries who have already joined the COVAX Advanced Market Commitment initiative created to pool demand and secure lower prices for bulk purchases of a COVID-19 vaccine.

Meanwhile, Moderna is pulling ahead in the COVID-19 vaccine rat race as the first company to publish results from Phase I clinical trials in a peer reviewed journal, the New England Journal of Medicine, on Tuesday. Some 21 vaccine candidates are in human trials, although none have yet been given full regulatory approval.

The COVAX Facility is one initiative to set up a global system to buy and distribute an approved COVID-19 vaccine as soon as it hits the market in an effort to minimize the lag normally experienced between a vaccine receiving regulatory approval, and its deployment to people in need, particularly in low- and middle-income countries. Hosted by Gavi, the Vaccine Alliance, the Facility aims to subsidize lower-income countries’ vaccine purchases with voluntary donations to GAVI’s Advance Market Commitment. 

““For the vast majority of countries, whether they can afford to pay for their own doses or require assistance, it means receiving a guaranteed share of doses and avoiding being pushed to the back of the queue, as we saw during the H1N1 pandemic a decade ago,”  said CEO of Gavi Seth Berkley in a press release

“Even for those countries that are able to secure their own agreements with vaccine manufacturers, this mechanism represents, through its world-leading portfolio of vaccine candidates, a means of reducing the risks associated with individual candidates failing to show efficacy or gain licensure,”  he added.

However, some critics have cautioned that the COVAX Facility could inadvertently allow rich countries to buy up vaccines more quickly than poor countries. High-income countries could sign their own deals with pharma companies, and also benefit from allocations from Gavi, without being required to contribute to the Advance Market Commitment, according to Associated Press. 

““By giving rich countries this backup plan, they’re getting their cake and eating it too,” Anna Marriott of Oxfam International told Associated Press. “They may end up buying up all the supply in advance, which then limits what Gavi can distribute to the rest of the world.”

Berkley has dismissed such criticisms.

The Facility’s ambitious goal is to deliver two billion doses of safe, effective COVID-19 vaccines by the end of 2021. So far, the US $300 million of the US $2 billion goal for the Advance Market Commitment has been raised from high-income donors.

Moderna Releases Positive Phase I COVID-19 Vaccine Results in Peer-Reviewed Journal

Colorized electron micrograph of SARS-CoV-2 (yellow) attacking a dying cell (red)

All 45 participants in Moderna’s Phase I COVID-19 vaccine trial developed neutralizing antibodies, the type of antibodies able to bind to the virus and prevent it from infecting human cells.

Two 100 microgram doses of the vaccine spaced 28 days apart were able to induce antibody levels 4.1 times higher than levels seen in recovered COVID-19 patients. The vaccine, mRNA-1273, was also able to induce a Th1-biased CD4 T cell response. Phase II study participants have already been enrolled.

“These Phase 1 data demonstrate that vaccination with mRNA-1273 elicits a robust immune response across all dose levels and clearly support the choice of 100 µg in a prime and boost regimen as the optimal dose for the Phase 3 study,” said Chief Medical Officer of Moderna Tal Zaks in a press release.

Moderna plans to begin testing a 100 microgram dose of the vaccine in over 30,000 volunteers for a Phase III study set to start in late July. The Phase III trial, titled COVE, will measure how well the vaccine protects against symptomatic COVID-19 disease, infection by the COVID-19 causing virus SARS-CoV-2, and severe COVID-19. 

The highly anticipated results from the Phase I trial, a collaboration between Moderna and the United States National Institute of Allergies and Infectious Disease, comes as the US continues to hit sober new highs for the number of new coronavirus cases, with new records set daily for the past week. The US reported more than 67,400 new cases on Tuesday, according to Johns Hopkins University’s COVID-19 cases tracker.

Image Credits: US NIH, NIAID.