Drugs and Maybe Covid Vaccines Headed to India

28.04.2021 - As India’s Covid-19 infections soar and the death toll nears 200,000, wealthier countries – including the US, UK, Germany, France and Australia – are rushing supplies of oxygen, ventilators and protective gear to the subcontinent.

The World Health Organization (WHO) has said it is working to deliver 4,000 oxygen concentrators, and at least two major US drugmakers have pledged to send drugs thought to show promise against the virus. Meanwhile, the Indian government is pleading for help in securing access to vaccines, with US AstraZeneca doses firmly in its sights.

Biopharmaceutical company Gilead Sciences, based in the US state of California, has promised to send at least 450,000 vials of its antiviral drug remdesivir (Veklury), which reportedly helped former US president Donald Trump recover from the virus last year. The drug is approved in India for emergency use in severe Covid applications, although WHO has cast doubt on its effectiveness.

According to the Reuters news agency, Indian hospitals are facing supply shortages of remdesivir due to indiscriminate use, and the drug is being sold on the black market for more than 10 times its listed price – similar to the situation seen last year for the old malaria drug hydroxychloroquine, which was touted by Trump.

Gilead also plans to offer technical assistance to its Indian manufacturing partners. Seven companies reportedly have licensed the drug, with an estimated installed capacity totaling about 4 million units per month. The drugmakers are said to be currently scaling up batch sizes and adding new plants and local contract manufacturers.

US pharma giant Merck & Co has announced a non-exclusive partnership with seven Indian generic drug producers, among them Cipla, Dr. Reddy’s, Emcure Pharmaceuticals, Hetero Labs and Sun Pharmaceutical, to expand production and access to its experimental Covid drug molnupiravir in India and other low- and middle-income countries, once it is approved by local regulatory authorities.

India hopes for US AstraZeneca doses

India’s biggest hope is that it will get the bulk of the 60 million doses of the AstraZeneca Covid vaccine, Vaxzevria, the US has promised to release. President Joe Biden said on Apr. 26 that up to this amount could be made available in the coming months, pending federal safety clearance. “Give that AstraZeneca is not authorized for use in the United States, we do not need to use AstraZeneca in our fight against Covid over the next few months,” press secretary, Jen Psaki, said.

The Biden administration has already sent 4.2 million doses of the Anglo-Swedish drugmaker’s vaccine to Canada and Mexico, but called it a loan – observers said this was for fear of being accused of emptying the US strategic stockpile, which was a major talking point as the pandemic began last year.

AstraZeneca has not applied for a US emergency use authorization, and the Food and Drug Administration has been taking its time approving its vaccine. However, millions of doses have been produced for the company by CMDOs in the US under a contract agreed last year with the government’s Biomedical Advanced Research and Development Authority (BARDA) and are going unused.

The UK, which is the biggest customer for the AstraZeneca vaccine, does not intend to send any doses to India, as it has no surplus at the moment and is prioritizing vaccinating its own population, a spokesman for prime minister Boris Johnson told Reuters. He added, however, that his government would keep the matter “under review.”

India’s own export ban not helping its cause

India’s plight is awakening sympathy, but is also putting it in the awkward position of having to defend its export ban on vaccines as well as drugs such as remdesivir, imposed a few weeks ago. Serum Institute of India (SIL) previously had made millions of doses of Vaxzevria for other countries and for Covax, the United Nations-backed effort to distribute free shots to low- and middle-income countries. The UK also expected to get some Indian-made doses through its contract with AstraZeneca.

As late as mid-April, the Indian government defended the export ban while touting the success of its own vaccination drive, which the Hindustan Times boasted was the world’s largest. Reports said the export restrictions have also highlighted a major weakness in the Covax initiative. At last count, the organization had expected to ship 145 million vaccine doses by the end of May, after earlier pledging nearly 240 million. So far, it has delivered only 49 million doses out of its goal of 2 billion.

Author: Dede Williams, Freelance Journalist