Vaccine Works On Strain Found In India, Says Pfizer, Insists On Indemnity

Pfizer has told the government its Covid vaccine shows "high effectiveness" against the India-dominant variant experts believe is behind the second wave of infections in the country, sources told news agency PTI Wednesday.

Pfizer also told the government its vaccine had been proven suitable for everyone over 12, and can be stored for a month in cold storage facilities with a temperature range of 2-8 degrees Celsius.

The American pharma giant is in talks with the government over fast-track approval to roll out five crore doses between July and October - if it receives significant regulatory relaxations, including indemnification, or protection from compensation claims in case of adverse events.

The two sides have held a series of meetings over the past few weeks, some of which also involved Pfizer Chairman and CEO Albert Bourla, to resolve issues, including grant of legal indemnity.

None of the three vaccines currently approved for use in India - Covishield, Covaxin or Sputnik V - have been given such protection. Pfizer has insisted on this, which it has been given by other countries that use the drug, including the United States and several European nations.

Further, neither of India's approved vaccines have been cleared for use on those below 18, although Covaxin is expected to begin trials for the 2-18 age group by the month's end.

Children and young adults - who some experts fear could be the target of the third wave - accounted for fewer than 10 per cent of new cases this month, but week-by-week numbers showed an increase.

According to PTI, Pfizer told the Indian government it should "rely on the 44 authorisations, including WHO approval (to) facilitate emergency use authorisation..."

The company, however, is open to considering surveillance of the first 100 subjects to get its vaccine.

Pfizer, sources told PTI, has shared the most recent data points regarding trials, efficacy rates and approvals from various countries and by the World Health Organization (WHO).

These include data from the UK's Public Health England, which said an observational study concluded the Pfizer vaccine offered 87.9 per cent protection against the B.1.617.2 variant reported in India. 26 per cent of study participants were of "Indian or British Indian" ethnicity.

Other issues key to accelerating approval for the Pfizer vaccine are procurement through a central government pathway and regulatory requirement for post-approval bridging studies.

Pfizer (and Moderna, another US pharma giant with a Covid vaccine) was last week approached by the Delhi government, which was looking to buy vaccines directly from them. The offer was rejected; Pfizer cited company policy to say it would only deal with the central government.

Moderna cited similar policies to refuse the Punjab government.

India has administered over 20 crore vaccine doses so far, but is still a long way short of vaccinating a significant-enough proportion of its 130-crore population.

A shortage of vaccine doses is believed to be one of the primary reasons for the recent slowdown, with several states flagging low stocks and being forced to suspend vaccination for the 18-44 age group.

At present India has Covishield (developed by AstraZeneca-Oxford University and manufactured by the Serum Institute) and Covaxin (developed and manufactured by Bharat Biotech).

A third - Russia's Sputnik V - has been approved and is to be rolled out soon.

Domestic vaccine production figures were in the headlines this week after the government told the Kerala High Court over 8.5 crore doses are manufactured every month, or around 28.33 lakh per day.

However, given an average 12 to 13 lakh doses administered per week, or around 57 per cent, questions have been raised against the backdrop of states' concern over shortages.

Last month the government indicated it was ready to speed up grant of emergency use approval for foreign-made vaccines, including those made by Pfizer and Moderna.

With input from PTI