COVID-19 vaccine: Hope and Hype

With hope overruling everything in the crisis confronting the world due to COVID-19, the race for developing a potential vaccine is entering unchartered and worrying areas.

Usually, vaccines are not big money earners like ‘block buster’ drugs but more life savers over time through preventive action. However, the scale and gravity of the problems posed by COVID-19, affecting almost 200 nations with billions of people, has turned the promised vaccine and drugs into a multi-billion dollar opportunity.

By fast tracking the development process and loosening up regulatory mechanisms, the dangers of marring the scientific rigour and setting up precedents of ‘Made to order’ vaccines with not fully proven efficacy have emerged on the horizon.

The announcement by Russian President Vladimir Putin that a vaccine developed in the country (Sputnik V) has been registered and the first dose given to his own daughter has raised the hackles of the scientific community.

Some of the Western nations, India, China and big corporates, which are all in the race of the century to come up with the ‘Magic Shot Vaccine’, are only a step behind, making periodic announcements/claims of achieving rapid progress.

The WHO lists at least six vaccines in the final stages of Phase 3 human trials. These include the Oxford Group, Pfizer in tie-up with BioNTech; CanSino and CureVac; Moderna as front runners now. While hope and hype wish for a vaccine by the end of 2020, realists and experts pin some hopes of 2021.

While advances in technology, big data analysis and advantages of pre-existing knowledge do work in favour of accelerating the development process, short cuts and compromises on size and diversity in trials are not desirable, experts argue.

William Haseltine, a former Harvard Medical School professor and chair and president of the think tank, ACCESS Health International, observed in a recent article, “Faith in medicine and science is based on trust. But today, in the rush to share scientific progress in combating COVID-19, that trust is being undermined.”

Private companies, governments and research institutes are holding news conferences to report potential breakthroughs that cannot be verified. The results are always favorable, but the full data on which the announcements are based are not immediately available for critical review, he said in an article for The Washington Post recently.

Vaccine Nationalism:

The unprecedented crisis that COVID-19 forced on many nations has also elicited a rather unprecedented response. In the words of Dr Sowmya Swaminathan, the Chief Scientist of the WHO, “With over 200 COVID-19 vaccine candidates in development and 27 of them on clinical trials, there is a need to have a multilateral or global approach to vaccine deployment and distribution, rather than a more nationalistic.”

Russia announced Sputnik V on August 11, which instantly set off a wave of criticism, specially from the West. WHO lists the vaccine as in its earliest stage of development. However, the Gemalaya Institute, Moscow, and Russian Direct Investment Fund say the vaccine is going through the last phase of human trials.

But then, the US, UK, China and India too are not far behind in backing efforts to produce a vaccine by their own public funded research institutes and corporates. A combination of political-business-life saving supremacy role is also sweeping the leadership in some of these nations as the world battles the pandemic.

The Chinese have already approved one of its candidate vaccines to be tried on soldiers without Phase 3 trials. It has also granted the first vaccine patent to CanSino.

The US is pouring millions of dollars through grants to corporates like Moderna, in collaboration with the National Institute of Allergic and Infectious Diseases (NIAID) which is among the front runners with a RNA-based vaccine. Anthony Fauci, virologist, Director - NIAID and adviser to US President Donald Trump has claimed that a vaccine which is 50 per cent effective would be enough to bring back normalcy in a short time. Though, he hastened to add that a vaccine would be available only in early 2021.

The Trump administration has pre-booked billions of doses of vaccines from various manufacturing companies across the world too in a bid to secure the health of its citizens.

So is the case with the UK and its Prime Minister, Boris Johnson. The Oxford University led vaccine in collaboration with Astra Zeneca has India’s Serum Institute, Pune as the lead manufacturer. Adar Poonawala, its Managing Director, has also unveiled ambitious plans of human trials, production and supply to both India and the world.

Vaccine side effects:

Statistically, the demand for the vaccine is in billions of doses. The risks of side effects, even it is as low as 1 or 2 per cent can mean a few million people. Hence, the extra care that’s required in the vaccine testing and trials, say experts.

Merck CEO Ken Frazier has been quoted, “Attempt to get a vaccine this year is very unlikely as it’s a long process with a reason. It’s not political red tape that can be cut, trials of thousands take time. Data collection, protocols, surveys, long- term safety data are all must.”

The classic case of the side effects children faced in Philippines in 2016 after being administered the Dengue vaccine, Dengvaxia, is fresh in memories.

Similarly, around 2013, a few young girls reportedly died due to the side effects of the cervical cancer ‘Gardasil’ vaccine against HPV, in trials carried out by the NGO, PATH, funded by Bill and Melinda Gates in Khammam district of Andhra Pradesh.

India Efforts:

India also jumped into the race with the ICMR issuing a fiat in early July to institutes involved in trials to speed up and ensure some positive development by August 15, probably so that Prime Minister Narendra Modi could make a big announcement from the Red Fort in his address to the nation.

Rightly, the move attracted strident opposition and caution from the national science academies and concerned experts. The ICMR retracted it, by saying it was a call to accelerate the development process only.

The PM stated that three vaccines were at different stages of testing. The roadmap for production and distribution was ready. As soon as scientists give the green signal, large scale production will begin. He assured that every Indian will get the vaccine shot.

The vaccine developed by the consortia of Bharat Biotech, ICMR and National Institute of Virology as well as Zydus Cadila are in Phase 1 and 2 clinical trials. Serum Institute is doing Phase 2 and 3 clinical trials.

The Chairman of Bharat Biotech has gone on record to state that a vaccine from their work would take at least 6 months to a year to be ready after due regulatory approvals.

Though India produces more than half of the world’s vaccine doses, production of a few billion doses at present, the task of reaching a COVID-19 vaccine to 1.3 billion is anything but ‘Herculean’. A definite strategy, prioritising who should be given first and building infrastructure to store, transport and inject people has to be put in place.