Serum Institute, the Indian manufacturer of the Oxford-AstraZeneca vaccine, now says that they will not be able to export the vaccine before June or July. Managing director of Beximco Pharma, Nazmul Hassan, has expressed their helplessness in this regard and has said that Serum has no right to halt supply since Bangladesh has paid in advance. He appealed to the government to make diplomatic efforts, but that has not been very successful. And given the spike in coronavirus cases in India and the record number of deaths there, it is not likely they will relax the restrictions on exports any time soon.
Vaccine supply has emerged globally as an extremely sensitive political issue. It has stirred considerable commotion among neighbours of Europe and America. Diplomatic tensions emerged between the European Union and the UK when the British-Swedish AstraZeneca failed to supply the committed number of vaccines. This conflict with AstraZeneca prevails. The European Union has even filed a case against AstraZeneca.
Meanwhile, India used this AstraZeneca vaccine to launch into a diplomatic competition with China, providing two dozen countries, including Bangladesh, with a gift of at least 35.7 million (3 crore 57 lakh) doses of the vaccine (Source: Indian foreign ministry). In fact, exports were held up initially at the start of the year and Bangladesh received 2 million (20 lakh) doses as a gift. Another 1.3 million (13 lakh) doses also came in two more phases as gifts. But of the 15 million (1.5 crore) doses of the vaccine for which advance payment has been made, only 5 million (50 lakh) has been received so far.
Political friction over vaccines has emerged in America too, between the US and its neighbours including Canada, Mexico and others.
The countries are buying additional doses and alternative types of the vaccine as an insurance against any possible problem that may arise with the vaccine of their choice. So they have a stockpile of vaccines which are not essential. The US is a major example.
Wealthy countries build up stock
At the heart of this problem lies a lack of global understanding regarding the vaccines. The wealthy countries did not respond to the World Health Organisation’s proposed policy for priority and distribution of the vaccine based on the extent of risk. In absence of a global agreement, there are no restrictions on how many vaccines countries can purchase in proportion to their actual need. As a result, certain wealthy countries have signed agreements for 3 to 9 times more vaccines than they require. According to the global vaccine alliance, wealthy countries have purchased more than half the potential vaccines to be produced for their citizens. Yet the number of citizens in those countries makes up only 14 per cent of the world population. There is no question about the governments’ responsibility towards the citizens of their respective countries, but can buying and stocking more than required be justified in any way?
The countries are buying additional doses and alternative types of the vaccine as an insurance against any possible problem that may arise with the vaccine of their choice. So they have a stockpile of vaccines which are not essential. The US is a major example. They have millions of AstraZeneca doses in stock though this has not been approved for any citizen of their country. On Thursday the White House declared it would release 60 million (6 crore) doses from that stock for India and some other countries. The US says it is only sending these vaccines to other countries after testing that these were safe. The remaining stock of various vaccines will be tested too.
Like the US, others such as Canada, UK and the European Union also have excess stock of the vaccine. Various civil groups and health experts in those countries have been appealing to their governments to give these vaccines to others, but there has been no response to such appeals.
Manufacturers’ indemnity clauses
There is a different sort of problem for vaccines to be sent to other countries from countries that have surplus stock or have large procurement orders pending. The manufacturing companies have indemnity clauses with the procuring countries. If there is any adverse reaction to the vaccine, the affected persons will not be able to file any criminal, civil or compensation suit against the companies. If they do, the government of the concerned country will be liable to pay damages, not the companies. This non-liability clause also poses as a legal problem for these countries to handover the vaccines to any third country.
The conditions are extremely stringent and extremely confidential too. However, a report published by the Bureau of Investigative Journalism in February revealed that Pfizer had demanded sovereign asset guarantee from certain Latin American countries. These included federal bank reserves, embassy buildings or military bases. Pfizer, however, did say that they had no desire to touch any military, cultural or diplomatic assets of any country. South Africa’s health minister Zweli Mkhize, after discussions with Pfizer and other vaccine manufacturers, expressed his frustration on 14 April about the “difficult and sometimes unreasonable” terms.
Some such terms put forward by Pfizer include indemnity against cases filed regarding the company’s own negligence, fraud or malice. The Bureau of Investigative Journalism saw in the contracts between Pfizer and the Dominical Republic, Albania and Peru that the company sought to be indemnified against problems at any step of the supply chain, including packaging, manufacturing and storage. Experts said that these were “unreasonable”.
We do not know about the terms and conditions of Bangladesh’s agreement with Serum. Similarly, due to the confidentiality clause, we do not know about the details of the agreement signed with Russia.
In a recent Tweet, the CEO of India’s Serum Institute, Adar Poonawalla, appealed to the US president Biden to relax the restrictions on the export of raw materials. He said that the shortage of raw materials had hampered the production of vaccines in keeping with capacity and demand. The US defence production act next came into focus. This act obliges companies to first meet the domestic demand of the country. Former US president Donald Trump invoked this act when the pandemic first broke out, and this had an impact on the export of personal protective equipment (PPE), ventilators and drugs.
There is no sign of any curative drug in sight either. So it is imperative to demand for patents to be relinquished and also to manufacture vaccines ourselves
How many vaccines are needed globally?
In response to the criticism erupting over export of raw material to India being held up because of that law, White House’s Covid-19 supply coordinator Tim Manning highlighted certain significant factors. He said every year 4 billion (400 crore ) doses of vaccines are made against various global outbreaks like flu and measles. There is a shortage of raw materials. He said no company had been restricted by this act to export. They were just told to first meet the country’s domestic demand. This undoubtedly had an effect on exports. On Monday the US announced certain relaxations of the restrictions for India.
UNICEF’s Covid-19 vaccine market dashboard gives updates of vaccine supply, production and procurement contracts with various countries. It shows that till date 11.60 billion (1,160core) doses are being arranged globally. Of this, COVAX has arranged 3.56 billion (356 crore) doses. However, there is no indication of when these can be supplied. Till Tuesday, 14 types of COVID-19 vaccines have received emergency/condition or state approval. Of these, enlisted with WHO for emergency use are Pfizer-BioNtech, AstraZeneca and Janssen. US’ Moderna and China’s Sinopharm are to be finalised for the list within April. China’s Sinovac may be finalised by May. Russia’s Sputnik V vaccine awaits certain additional details and inspection. Our drug administration, however, has given this its approval before WHO, for emergency use. Around 60 countries have given the nod to Sputnik V for emergency use.
Production will increase if intellectual property rights are relaxed
In May 2020, WHO called upon all countries to voluntarily share knowledge, intellectual property, technology and data to tackle COVID-19. Global civic bodies like Global Justice appealed to the large pharmaceutical companies to keep COVID-19 research and technology open and free licence for patent-free vaccines. They said this should be a people’s vaccine. Many others have added their voices to this demand. On 14 April, the heads of state and government of 170 countries as well as Nobel award winners, appealed to the US president Joe Biden to keep the COVID-19 vaccine free of intellectual property rights. The editorial board of the New York Times on 24 April made the same appeal in a special editorial.
The new head of the World Trade Organisation, Ngozi Okonjo-Iweala, came up with a third alternative. Instead of suspending the patent, she advised voluntary provision of licenses. Pointing to the agreement between India’s Serum Institute and AstraZeneca, she said developing countries now had some untapped capacities. Others could follow the example of Serum Institute. But with AstraZeneca, and Serum Institute which it has licensed, failing to meet commitments, the weaknesses in their business dealings has come to light. It has become clear that despite being known as the largest manufacturer of vaccines in the world, Serum is not capable to meeting the burgeoning demand of the region.
In this backdrop, along with procuring WHO-approved vaccines, priority must also be given to the possibility of production partnerships. It is not likely that the world will be rid of this virus any time soon. There is no sign of any curative drug in sight either. So it is imperative to demand for patents to be relinquished and also to manufacture vaccines ourselves.
* This column appeared in the print and online edition of Prothom Alo and has been rewritten for the English edition by Ayesha Kabir