US policy change to boost vaccine production: Poonawalla

The US administration has announced that because of the success of US vaccine manufacturers, it is confident about supplying its authorised vaccines, reports Asian Lite News

The CEO of Serum Institute of India (SII), Adar Poonawalla, has said on Friday that the US policy change on vaccines will increase the supply of raw materials globally and to India and boost vaccine production.

Thanking US President Joe Biden and External Affairs Minister S. Jaishankar for the policy change, Poonawalla tweeted, “Thanks to the efforts of @POTUS, @WhiteHouse, & @DrSJaishankar, this policy change will hopefully increase the supply of raw materials globally and to India; boosting our vaccine production capacity and strengthening our united fight against this pandemic.”

The US administration has announced that because of the success of US vaccine manufacturers, it is confident about supplying its authorised vaccines.

“As a result, we’re removing the DPA priority ratings for AstraZeneca, Novavax and Sanofi. While the manufacturers will continue to make these three vaccines, this action will allow US-based companies that supply these vaccine manufacturers to make their own decisions on which orders to fulfil first,” the US administration said in a briefing.

“And the President has announced a US commitment to sharing a total of 80 million doses by the end of June. This is five times the number of doses any other country has committed to sharing. And these 80 million doses represent 13 per cent of the total vaccines produced by the United States by the end of this month,” it added.

US National Security Advisor Jake Sullivan said, “We’ve received requests from all over the world, and a number of important factors went into our decision about how to allocate these first 25 million vaccines. These factors included achieving global coverage, responding to surges and other specific urgent situations and public health needs, and helping as many countries as possible who requested vaccines.”

“Our approach also prioritises South and Southeast Asia, including countries like India, Nepal, the Philippines and others that are undergoing surges right now. It recognises our closest neighbors, Canada and Mexico, which received our first shared vaccines; and friends like the Republic of Korea, where our military shares a command. And it prioritises other partners around the world, including countries with low vaccination rates or dealing with urgent present crises, like the West Bank and Gaza, Ukraine, Kosovo, Iraq, Haiti and others,” Sullivan added.

Earlier on April 16, Poonawalla had tweeted for lifting the embargo on raw materials.

“Respected @POTUS, if we are to truly unite in beating this virus, on behalf of the vaccine industry outside the U.S., I humbly request you to lift the embargo of raw material exports out of the US so that vaccine production can ramp up. Your administration has the details,” he had said.

SII sought indemnity from liability

Serum Institute of India has also sought indemnity from liability, expressing the hope that rules would be the same for everyone, said sources.

This comes as the Centre is favourably considering granting indemnity against legal proceedings to foreign vaccine makers Pfizer and Moderna prior to their rollout in India.

“All vaccine makers, whether Indian or foreign, should be granted the same protection,” the Adar Poonawalla-led company has reportedly told the government.

“Not just Serum Institute of India (SII), all the vaccine companies should get indemnity protection against liabilities if foreign companies are granted it,” it further said.

It is learnt that Serum is hoping that rules should be same for everyone.

Besides Oxford-AstraZeneca’s Covishield vaccine and Novovax’s Covovax, the SII has also applied to the Drug Controller General of India (DCGI) to manufacture the Russian ‘Sputnik V’ Covid-19 vaccine in India. ‘Sputnik V’ is currently being imported by Dr Reddy’s Laboratories.

According to reports, the Centre is apparently considering granting indemnity to vaccine manufacturing companies if they applied for Emergency Use Authorisation (EUA). Till date, no Indian vaccine company has ever paid indemnity and neither has the Central government, the biggest vaccine user, done so.

Biden (Twitter@POTUS)

Advanced trials are on for Covovax being developed in collaboration with the pharma company Novovax. Codagenix, a single-dose nasal vaccine, is in phase 1/2 trials in the UK. The third, SpyBiotech, is a novel virus-like particle vaccine, which is also in trials.

The government has so far not given any manufacturer indemnity or protection against legal action for any severe side effects.

This is a key condition put forth by foreign vaccine-makers Pfizer and Moderna for supplying to India.

Countries like the US have granted indemnity from liability to Covid vaccine manufacturing companies for the possibility of something going wrong with their vaccines. They cannot be sued for compensation if there are any adverse effects from the shot.

Dr V.K. Paul, the head of the National Expert Group on Vaccine Administration, had said last month that the government is engaged with Pfizer and they have indicated the availability of a certain amount of vaccine in the coming months, possibly starting in July.

“We are looking at what their expectations from the government are and they are looking at what our expectations from them are,” Paul said, adding they have requested indemnity to all the nations including the country of origin.

The NITI Ayog member (Health) also said that the government is also examining the request and will take a decision in the larger interest of people and on merits.

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