US looking at joint production of Johnson & Johnson vaccine in India

The US is looking at the joint production of the Johnson & Johnson Covid-19 vaccine in India and ways to help Indian manufacturers such as the Serum Institute of India (SII) ramp up production to meet vaccine needs around the globe, a senior American diplomat said on Tuesday.

US chargé d’affaires Daniel Smith said the US stockpile of AstraZeneca vaccines –currently believed to be 10 million doses – can’t be shared with other countries till the jabs are certified as safe and effective by the Food and Drug Administration (FDA) because of problems associated with the plant that manufactured them.

Smith, a career diplomat who served as acting secretary of state, was named the acting head of the US mission in New Delhi last month to help oversee the Biden administration’s efforts to help India cope with a devastating second wave of the pandemic that has seen daily infection rates surge well past the 350,000-mark for several days.

He told a virtual news briefing the US administration is working on the Indian government’s list of raw materials and other supplies urgently needed to manufacture vaccines but cautioned this wouldn’t be an easy task because of disruptions to global supply chains.

“We are now working closely with them to go through this list to decide what is available, what we can provide and how quickly we can provide that. I just want to say this is not an easy task, that is, there are global challenges in the global supply chain right now when it comes to precursors and raw materials necessary for these vaccines,” Smith said.

In addition to working with SII and other Indian vaccine manufacturers on ways to boost production, the US is looking into the joint production of the Johnson & Johnson vaccine in India and encouraging private sector discussions to ramp up manufacturing.

“I know [the US International] Development Finance Corporation (DFC) is looking at how we can invest so that we can help produce the Johnson & Johnson vaccine here in India,” Smith said.

Following the maiden summit of the Quadrilateral Security Dialogue or Quad in March, the group announced that the DFC will assist India’s Biological E to produce a billion doses of Covid-19 vaccines to be rolled out by the end of 2022 under a new vaccine partnership for the Indo-Pacific region. The initiative was aimed at creating additional manufacturing capacities in India to make doses developed in the US, including the Johnson & Johnson candidate, with financing from the US and Japan.

“I think we are watching carefully the production levels at the SII and elsewhere. We’ve been in close touch with the SII to try to determine what raw materials we could provide, and assistance that we can provide to help boost production. But that’s an issue with vaccines across the board, it’s not simply with the AstraZeneca vaccine in that regard,” Smith said in response to a question from HT about what India and the US are doing to ramp up production to help other countries through the Quad.

Smith said the US has also diverted enough AstraZeneca manufacturing supplies from its own pre-existing orders to produce more than 20 million doses in India.

SII CEO Adar Poonawalla has said in recent days that the raw materials needed from the US – whose supply was held up after the Biden administration invoked the Defense Production Act – are required for making Covovax, the vaccine developed by Novavax.

At a time when India and other countries are hoping the US will begin shipping doses from its stockpile of some 10 million doses of the AstraZeneca vaccine, Smith said this wouldn’t be possible till the FDA certifies the safety and efficacy of the vaccines made at a plant outside Baltimore.

The FDA is investigating an error at the Baltimore plant that led to ingredients of the AstraZeneca shot contaminating a batch of the Johnson & Johnson vaccine, which was being made at the same facility.

“I know that there are a number of doses of the AstraZeneca vaccine that were made in the plant outside of Baltimore, but there were problems with this plant. So far, the FDA hasn’t certified that these vaccines are available for anyone’s use, for export or not. So I can’t say when that will happen or what will be done exactly as we go forward,” Smith said.

The Biden administration, he added, decided not to use the AstraZeneca jabs as it has sufficient stocks of three other vaccines and is “eager to supply these to the world but we won’t do so before we’re assured that they are safe and effective”.

The US is determined to do all it can to help boost India’s vaccine production because Washington recognizes New Delhi’s critical role in helping the world counter the pandemic. “Our global partnership with India, when it comes to vaccines and vaccine production, is essential for the world’s emergence from this pandemic. We recognize that in helping India, we’re helping a lot more than just India,” Smith said.

Smith also cautioned that a proposal by India and South Africa for waiver of patent protections for Covid-19 vaccines at the World Trade Organization (WTO) would be a long and complex process despite support extended by the Biden administration.

“The WTO is a consensus-based organization. So, we’re going to have to negotiate this with our partners in the WTO as we go forward...We’re not just waiting for that to take place, what we’re also doing is ramping up all of our efforts across the board, in partnership with India and other countries, to increase production of Covid-19 vaccines and increase availability,” he said.

“We are concerned obviously with the current course of the pandemic in India, not simply because of the humanitarian catastrophe but the fact that it has global implications...India’s role as the supplier for not just what was envisioned by the Quad but for much of the world when it comes to vaccines is critical,” he added.

As the world’s largest manufacturer of vaccines, India exported more than 65 million doses of Covid-19 vaccines under its “Vaccine Maitri” initiative but supplies have slowed to a trickle since March as domestic infection rates surged.

Smith said the US plans to work with European partners and other countries that have additional AstraZeneca doses to help countries in the region whose vaccine supplies were affected once India began focusing on its second wave. “The challenge is nobody has studied the viability of using a different vaccine for the second dose...Some countries may even resort to starting over with the Pfizer or Moderna vaccine but obviously, if we could solve this by providing a second dose of the AstraZeneca vaccine, that would be the simplest and best solution,” he said.

He outlined the aid worth more than $100 million that the US has provided to India, mainly oxygen-related equipment and medical supplies, and said the US side is working closely with the Indian government on the use of this official assistance. “I think we have very good visibility to where that assistance is gone,” he added.

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Courtesy: hindustantimes