Pfizer (PFE) CEO Albert Bourla said during the company's earnings call Tuesday that efforts to provide India with doses of its coronavirus vaccine are ongoing, but that it's up to the Indian government to bypass a policy requiring local trials before it can be authorized for use there.
"India wanted to do additional studies" in order to approve the vaccine, but Pfizer "was not ready to allocate resources" that were tied up in studying other aspects of the vaccine, such as efficacy for children and pregnant women, as well as booster shots, Bourla said.
“We are hopeful they will change this policy about conducting local trials," he added.
In the meantime, the company has pledged $70 million worth of medicines, including an anti-blood clot medication, as India continues to report more than 350,000 cases and 3,000 deaths every day.
Vaccines for India
The company announced it will increase vaccine production capacity to 3 billion doses for 2022, and is still taking in commitments for this year. Pfizer estimates its 2021 capacity is 2.5 billion doses, of which 1.6 billion have already been committed.
By comparison, competitor Moderna (MRNA) has capped out its production for the year, targeting about 1 billion doses. The two are the only mRNA vaccines being used against the coronavirus.
Global efforts for other platforms have hit a snag, as both AstraZeneca (AZN) and Johnson & Johnson (JNJ) suffered backlash for rare blood clots from their vaccines, and in AstraZeneca's case, the crisis in India has hampered global distribution.
The Serum Institute of India (SII), the largest vaccine maker in the world, has been pressured by the Indian government to circulate more doses domestically. It was central to global distribution efforts through the COVAX facility, the philanthropic joint venture that includes the World Health Organization.
Now, Pfizer is sharing doses through the facility, which targets 92 of the world's low and middle income countries.
"I think the Indian government, which tries very hard and is very careful with the health of their people, will eventually approve the vaccine based on the data we have submitted across the world. We are not ready to devote resources right now to study" the vaccine in a general population, Bourla told Yahoo Finance Tuesday.
Pfizer is focusing on variant-specific boosters and trials in children, which should all yield results in the second half of 2021. In addition, the company is working on a formula that allows longer stability at more normal refrigerator temperatures. Among approved vaccines, Pfizer's is the most needy, requiring ultra-cold temperatures for shipment and storage. This has made it harder for remote areas of the world to gain access and why companies like AstraZeneca and Johnson & Johnson were seen as vital to curbing the global pandemic.
India also has its domestic vaccine, from Bharat Biotech, in the mix. But those and the AstraZeneca doses from SII are still not enough. Pfizer was the first company to apply for emergency use authorization in India, and dropped the application in February after a discussion with regulators focused on the local trial policy.
"I hope that all of this will be resolved, and we will start sending doses of our vaccine to India," Bourla said.
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