Serum Institute’s inability to meet global commitment will disrupt vaccine supply chains: Gavi

A Vital Cog In The Wheel

So far, COVAX has delivered over 77 million vaccine doses to lower-income economies through the Gavi COVAX AMC (Advance Marketing Management) and self-financing participants.

Of this, Serum Institute's share stands at 30 million vaccine doses.

The AMC has already secured 1.3 billion doses for global delivery in 2021. This is enough to protect the most at-risk population groups: health workers, the elderly and those with underlying health conditions.

``We need an additional $2 billion to lift coverage in AMC countries up to nearly 30 percent, and we need it by the first week of June to lock in supplies now so that doses can be delivered through 2021, and into early 2022,” the Gavi spokesperson said.

A Serum Institute of India official told Moneycontrol that "at this stage we would not like to comment on this.’’

He, however, referred to a May 18, 2021, statement issued by SII CEO, Adar C. Poonawalla, which said that in January this year, ``we had a large stockpile of vaccine doses. Our vaccination drive had started successfully, and the number of daily cases being recorded were at an all-time low. At that stage, most people, including health experts, believed that India was turning the tide on the pandemic.”

Poonawalla said that: “Many other countries in the world were facing an acute crisis and were in desperate need of help. Our government extended support wherever possible during this period. It is this spirit that had initially led to cooperation between countries when the virus first emerged in the beginning of 2020. The cooperation between countries also forms the basis for us getting access to technology and aid for healthcare. Today, it is this reciprocity, where India has helped other countries with the supply of HCQ and vaccine exports, that has in turn led to support from other countries.”

Said the Gavi representative: "We are seeing the traumatic effects of the terrible surge of COVID-19 in South Asia – a surge which has also severely impacted global vaccine supplies.’’

He added: "We fully support India in its efforts to battle the virus at home. At the same time, we are making every effort to address COVAX’s short term supply shortfall. This includes calling on all countries that have doses to share them with COVAX, a removal of all bans and bottlenecks preventing manufacturing from scaling up and for countries and manufacturers to work together to ensure COVAX can access the vaccines it has procured as soon as possible.”

On his part, Poonawalla said the company has never exported vaccines at the cost of the people in India and remains committed to support the vaccination drive in the country, pointing out that "the statement was necessitated by the intense discussions on the decision of the government and companies to export vaccines abroad".

For good measure, he also said that SII hopes to reinstate vaccine supply to the global COVAX initiative by the end of the year.

A Global Initiative

Since COVAX was established in mid-2020, it has had the support and resources of 192 of the world’s economies.

With its own battle against the coronavirus taking a sharp turn for the worse, particularly by a rampant unpredictable second wave of the coronavirus, India has severely curtailed exports of COVID-19 vaccines, triggering setbacks for vaccination drives in many other countries.

The country is now holding back nearly all the vaccine doses that Serum Institute, one of the largest producers of the AstraZeneca vaccine, produces. It makes roughly 70 million doses of Covishield every month, accounting for nearly 90 percent of the total vaccine that India produces and consumes.

From mid-January to mid-April 2021, India was a major exporter of the AstraZeneca vaccine produced by the Serum Institute of India. More than 70 countries, from Djibouti to Britain, received vaccines made in India, with a total of more than 60 million doses.

According to the Ministry of External Affairs' Vaccine Maitri programme, a humanitarian and commercial initiative undertaken by the Indian government to provide COVID-19 vaccines to countries around the world, between mid-April and end-May 2021, this outgo had dropped down to a trickle of a little over 6 million doses.

Now, even that has stopped.

The outrage in India over exports of vaccines or what was termed as 'vaccine diplomacy’, when the country was facing a dire shortage of the antidote in the face of mounting death  toll, forced the government’s hand to curtail vaccine exports in a big way.

Senior government officials told Moneycontrol last month that the government has not restricted both SII and Bharat Biotech from supplying vaccines abroad, and no bans will be instituted on commercial exports.

"The government is focused on battling the pandemic with the support of India's domestic entrepreneurs. It lauds the companies for prioritizing the domestic market given the intensity of the second wave. However, they are free to export if they have enough doses," a senior official said.

Says Dr MC Mishra, Former Director, AIIMS: "The only way out of this shortage is by producing more vaccines.  Both Serum Institute and Bharat Biotech are increasing their capacities.”

Indian Needs Matter Here

India must first meet its own needs and then look at its global commitments, which have to be honoured and the government is not going to come in the way, he told Moneycontrol.

The country proposes to increase its vaccine production significantly. The Serum Institute is going for a month-on-month vaccine increase of 10 to 15 percent and by July 2021, is expected to touch the 100-million doses mark.

The other indigenous producer of vaccines, Hyderabad-based Bharat Biotech, whose product Covaxin is a relatively tiny affair, makes about 150 million doses a year.

The Department of Biotechnology informed the Parliamentary Standing Committee on Science and Technology, Environment, Forests and Climate Change earlier this year that the estimated manufacturing capacity of Covishield is 70-100 million doses every month while Covaxin has a planned production capacity of 12.5 million doses a month.

India could have more vaccines in the days ahead. Serum Institute has announced the launch of Covovax developed jointly by the company and Novavax, which is likely to be delayed until September. An official said that the phase II and phase III bridging trials for Covovax had begun.

In April, Bharat Biotech announced a scale-up of manufacturing capacity to produce 700 million doses of Covaxin annually.

“Manufacturing scale-up has been carried out in a stepwise manner across multiple facilities at Hyderabad, and Bangalore,” the company said in a statement.

To further increase capacities, Bharat Biotech has partnered with Indian Immunologicals (IIL) to manufacture the drug substance for Covaxin. ``The technology transfer process is well underway and IIL has the capabilities and expertise to manufacture inactivated viral vaccines at commercial scale and under biosafety containment,” the Hyderabad-based biotech company said in a statement.

Naturally, India is desperate for all the doses it can get. While experts have suggested an abating of the second COVID-19 wave, which saw a significant rise in the number of recorded deaths, with the total toll since the pandemic hit India in 2020 crossing 250,000 in May.

Of this number, around 40 per cent of the deaths have occurred since the beginning of March this year.

In May last month, Asia had reported over 5,600 daily COVID-19 deaths of which more than 4,000 were from India.

While figures vary, most experts believe that not more than 5 percent of the country’s 1.4 billion population has been vaccinated twice.

So, could it hurt India’s standing, diplomatically speaking, of not being able to meet its global vaccine guarantees in these extremely trying times?

According to former Indian Ambassador Deepak Vohra, fears about India losing face under the circumstances are grossly exaggerated.

"In all international dealings, there is the Force majeure clause. It is a common clause in contracts, which essentially frees both parties from liability or obligation when an extraordinary event or circumstance beyond the control of the parties, prevents one or both parties from fulfilling their obligations under the contract. If India had stopped the export of vaccines as part of policy or if the Parliament had disallowed it, it would be different. No one knew there was a second wave coming. All sensible people understand that, and India has been told so in as many words, privately of course,” he told Moneycontrol.

The next few months could, therefore, be crucial for vaccine production and their exports, and how India could cope up with a third wave, if it comes.