Covid-19: Indian vaccine manufacturer warns of raw materials shortage

 

India’s main vaccine manufacturer is calling on the US government to lift an export embargo on crucial raw materials used to prepare the jabs, to guarantee supply of the doses.

Adar Poonawalla, the CEO of Serum Institute of India (SII), the world's biggest vaccine manufacturer and which has supplied to countries in Africa, says a ban on raw material exports from the US is hurting the supply chain and could delay delivery.

Poonawalla spoke as India itself restricted exports of the finished vaccines after local cases of infections rose.

The government of Prime Minister Narendra Modi says, however, that it is simply slowing down exports to prepare an adequate protocol that will serve both local and international demands.

The SII, which has produced doses for India’s local use, and for the international market mainly under the Covax facility, is the main producer for the AstraZeneca vaccine.

Kenya received 1.02 million doses of the vaccine under the Covax facility and a donation of 100,000 from the Indian government’s ‘vaccine friendship’ programme.

Restrictions on raw materials and the finished vaccine may mean the second dose will be uncertain.

“Respected Potus ( President of the United States), if we are to truly unite in beating this virus, on behalf of the vaccine industry outside the US, 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," the CEO said in a tweet on Friday.

Last month, Mr Poonawalla disclosed that the production of Covid-19 vaccines in India had taken a hit because of the restrictions imposed by the United States and European countries on the export of critical raw material required to make them.

"I wish I could go there and protest in the US myself - to say that you are holding back critical raw materials that are required for Covaxin and so many vaccine manufacturers in India and other parts of the world," he said in an interview at the time.

However, Poonawalla believes that the shortage and struggle for raw materials is a short term predicament and that in a few months, they will be able to develop other vaccines.

 "SII is not looking to import raw materials from China because of its quality issues and other supply constraints," he stated.

Input challenges

In March, a meeting convened by UK-based think tank, Chatham House, suggested that the unprecedented increase in the demand for Covid-19 vaccines is creating a global shortage of critical production inputs including raw and packaging materials, consumables and equipment.

The discussion shed light on the current landscape of vaccine manufacturing and emerging supply chain challenges.

Chatham House said the signs of input supply challenges are being observed across all vaccine manufacturing steps, which include bioreactor bags, single-use systems, cell culture media (upstream), filters, gamma sterilisation (upstream and downstream), vials (fill-and-finish) among others .

"These individual challenges are amplified as the absence of any single input can disturb the entire manufacturing process," it added.

"It has become apparent that many Covid-19 vaccine input supplies of raw and packaging materials, consumables and equipment are in short supply which may result in several manufacturers not being able to meet their current vaccine manufacturing commitments.

“Such shortages will also impact the ability to manufacture other lifesaving vaccines and biologics. Mechanisms to ensure input supplies for current and increased manufacturing capacity intent need to be put in place with short, medium and long-term solutions," the discussion paper highlighted.

The meeting was convened in collaboration with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and other international stakeholders.

Thomas Cueni, the director general at IFPMA said, "Let's put the current challenge in perspective: the pre-Covid-19 global vaccine manufacturing capacity was 3.5 billion doses per year, 5 billion if you include seasonal flu shots.

“This year, for Covid-19 vaccines alone, manufacturers have scaled up new capacity from zero to 10 billion, doubling the world vaccine capacity of what is a very complex process in a matter of months, thanks to unprecedented industry commitment and collaboration.

“We should not be surprised if there are bumps along the road, in the manufacturing process itself as well as strains on the whole supply chain, starting with hundreds of raw materials needed to make vaccines."

India's situation

Meanwhile, Kenya's mission in New Delhi has been engaging in top notch diplomatic negotiations with its Indian counterparts in efforts to secure Kenya's second dose of the vaccine.

The country anticipates a batch of 2.5 million AstraZeneca doses by early May 2020.

Willy Bett, Kenya's High Commissioner to India, told the Nation in a phone interview that the high demand for vaccines in the Asian country is a major challenge.

"They have to meet demands at home before servicing our," the diplomat said.

Read: New dates for second dose as India sits on Covid vaccines

According to the International Monetary Fund (IMF) Chief Economist Gita Gopinath, India has played a key role during the pandemic by producing and dispatching coronavirus vaccines to many countries around the world.

"India has been at the forefront in fighting this pandemic. The country has played a very important role in helping the world in the global health crisis through its vaccination policies, she said.

Ms Gopinath pointed out that India makes up about seven per cent of the world GDP based on purchasing power.

"What happens in India has implications for many other countries in the world, especially countries in the region," she explained.

Earlier this week, India overtook Brazil to become the second most infected country behind the United States.

On Thursday, the country reported more than 200,000 new cases and more than 1,000 deaths over a 24-hour period, according to data from its Health ministry.

Since the beginning of April, the country has reported more than 1.9 million new cases and over 10,600 deaths, meaning it reported more than 652,000 cases between April 1 and April 7, the number nearly doubling in just a week.    BY DAILY NATION