WHO considering solidarity trial for Covid-19 vaccines

Solidarity trials for vaccines that are in early and mid-stage clinical trials aim to test vaccine efficacy in different geographies which can help speed up the regulatory process and also ensure that vaccine manufacturers have access to There is diversity in its trial participants which can help establish vaccine effectiveness across different ethnic and racial groups.

WHO spokesperson asked for additional details to answer questions Mint.

Vaccine makers in India and South Africa are in talks with the WHO to bring their vaccines to a solidarity trial, a senior official of a vaccine manufacturer in India said, requesting anonymity, as discussions are still private. . “We have agreed to participate in the trial after getting approval for our vaccine candidate from Indian regulators,” the official who was contacted by the WHO said.

The solidarity trial will look at new vaccine platforms such as messenger RNA (mRNA) vaccines that are under development.

Last year, WHO decided to set up a global solidarity trial for COVID-19 Treatment in 52 countries involving 600 hospitals to test the effectiveness of reused drugs such as remdesivir, interferon, hydroxychloroquine and lopinavir. The trials proved that these drugs had little or no effect on reducing mortality, length of stay and initiation of ventilation of hospitalized Covid-19 patients. In August this year, three more drugs were added to the trial, artesunate, a malaria drug, imatinib, an anti-cancer drug, and infliximab, a monoclonal antibody originally used to treat autoimmune diseases.

A solidarity trial for a treatment for Covid was possible because companies such as Gilead, IPCA, Johnson & Johnson and Novartis donated drugs for the trial. However, the biggest challenge for this initiative is the sharing of vaccine doses by countries and vaccine manufacturers. To start a multi-country trial of this scale, at least more than one million doses would be needed.

Many companies that are in the early and middle stages of Covid-19 vaccine development are facing hurdles in obtaining comparator vaccines as placebo control is no longer viable due to the availability of vaccines. In September, the Coalition for Epidemic Preparedness and Innovation (CEPI), a non-profit organization that funds vaccine research, called on governments and pharma companies to ease supplies for clinical trials.

“While the number of comparator vaccine doses needed to support clinical trials is small, Covid-19 vaccines are scarce and they are not available for purchase on the open market,” said Melanie Saville, CEPI’s director of vaccine research and development. Approved vaccines are bound by contractual agreements between vaccine companies and governments that limit the use of these vaccines to public vaccination programs, Saville said. “So far, vaccine manufacturers have been reluctant to change this arrangement, threatening to bring important Covid-19 vaccine research and development to a standstill,” Saville said.

One of the Indian vaccine companies contacted by WHO has also said that the company will be able to donate only a few doses for the initiative. In India too, vaccine manufacturers like Biologic E and Genova faced problems in vaccine development due to non-availability of comparator vaccines.