COVID vaccine: Pfizer seeks clinical trial waiver in India, but lacks data on Asians

Only 4.3% of Pfizer’s phase 3 trial participants were Asians, while the efficacy rate for the diverse ethnic group was just 74.4% against 95% for whites.

Experts say that since India has a diversified population, it is necessary to know the efficacy on people across the country.

US pharma major Pfizer may have asked for a clinical trial waiver while applying for emergency COVID-19 vaccine use in India, but the company’s own report showed a lack of data on Asian participants.

Only 4.3% of Pfizer’s phase 3 trial participants were Asians, while the efficacy rate for the diverse ethnic group was 74.4%, says the US company’s phase 3 data published in the New England Journal of Medicine on Thursday (December 10). On the contrary, the company’s overall efficacy was 95% for a cohort, which comprised 83% whites, a US Food and Drug Administration (FDA) report stated.

Also read: US approves Pfizer’s COVID vaccine as Trump calls it ‘medical miracle’

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“We know in the past there have been challenges in vaccination when they have been taken from the Western context to LMIC (low and middle-income countries) context. It is always better to have local data, and that is something they should be asked for,” Anant Bhan, a researcher in global health, bioethics and health policy, told The Mint.

Experts say that since India has a diverse population, it is necessary to know the efficacy of the vaccine on people across the country. Therefore, vaccine manufacturers should conduct large scale trials in India, they suggest.

Also read: Country’s first indigenous mRNA vaccine candidate gets nod for human trials

Suneela Garg, director of the department of community medicine at Maulana Azad Medical College, told The Mint, “Any efficacy rate that is over 60% is good enough. Even flu vaccines have similar efficacy as this mRNA vaccine. But we have to remember that this vaccine has more side-effects than the flu vaccine.”

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