The World Health Organization (WHO) is in talks with vaccine makers to start a solidarity trial for covid-19 vaccines that is modelled on the lines of a global solidarity trial for therapeutics, said people aware of the development.
The aim of the solidarity trial for vaccines that are in the early and mid-stage of clinical trials is to test vaccine efficacy across different geographies that could help speed up the regulatory process and also ensure that vaccine makers have diversity in their trial participants that could help establish vaccine effectiveness across different ethnic and racial groups.
A WHO spokesperson asked for additional details to respond to queries from Mint.
Vaccine makers in India and South Africa are in talks with WHO to get their vaccines to the solidarity trial, a senior official at a vaccine manufacturer from India said, requesting anonymity, as the discussions are still private. “We have agreed to participate in the trial once we receive an approval for our vaccine candidate from the Indian regulators,” said the official whose company was approached by WHO.
The solidarity trial would look at new vaccine platforms such as messenger RNA (mRNA) vaccines that are under development.
Last year, WHO decided to establish a global solidarity trial for covid-19 therapies across 52 countries involving 600 hospitals to test the effectiveness of re-purposed drugs such as Remdesevir, Interferon, hydroxychloroquine, and Lopinavir. The trials proved that these drugs had little or no impact on reducing mortality rates, duration 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 covid treatments was possible as companies such as Gilead, IPCA, Johnson & Johnson, and Novartis donated medicines to the trial. However, the biggest challenge for this initiative is likely to be the sharing of vaccine doses by countries and vaccine makers. At least more than a million doses would be required to start a multi-country trial of this scale.
Several companies who are in the early and mid-stage of covid-19 vaccine development have been facing hurdles in getting comparator vaccines as placebo controls are no longer viable due to the availability of vaccines. In September, the Coalition for Epidemic Preparedness and Innovations (CEPI), a not-for-profit organization funding vaccine research, called on governments and pharma companies to ease supply for clinical trials.
“While the number of doses of comparator vaccine needed to support clinical trials is small, covid-19 vaccines remain scarce and they are not available for purchase in the open market,” said Melanie Saville, director of vaccine research and development, CEPI. The approved vaccines are bound by contractual agreements between vaccine companies and governments that limit the use of these vaccines to public vaccination programmes, Saville said. “Thus far, vaccine manufacturers have been reluctant to change this arrangement, threatening to bring vital covid-19 vaccine research and development to a standstill,” Saville said.
One of the Indian vaccine companies approached by WHO has also said that the company will be able to donate only a few doses to this initiative. In India too, vaccine makers such as Biological E and Genova encountered problems with vaccine development due to the unavailability of comparator vaccines.
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