Monday 4 January 2021

Nothing incorrect about COVID-19 vaccine approvals by DCGI, but everything wrong with political bickering over it

Given its size, population, density, lack of public awareness, and poor health infrastructure, it was feared that COVID-19 would become a never-ending nightmare for India. For a while, till September, it threatened to do so. Then India turned it around. A lot of credit should go to the single-minded effort by frontline health care workers, scientists, laboratories, regulators and even the political class who showed a sense of purpose in keeping differences aside and drawing, implementing coordinated policies. A lot of credit should also go to the general public for the way they adhered to health guidelines, especially on wearing face covers or masks without any political debate or faux activism.

The importance of this cannot be overstated. From reporting almost 100,000 COVID-19 cases a day in September 2020, India has dramatically brought down that number. According to data from Union health ministry data on Monday, daily new COVID-19 cases in the country remained below 20,000 for the third consecutive day taking the virus caseload to1,03,40,469. Higher testing has led to a further decline in the cumulative positivity rate to 5.89 percent. Total cumulative tests in India have crossed 17.5 crore (17,56,35,761) with7,35,978 samples being tested on Sunday, reports PTI.

In contrast, the richer countries in the world are paying the price for politicizing the COVID-19 response. Study after study indicate a direct link between wearing a face mask and reduced rate of COVID-19 infections and yet there has been a stubborn resistance in the West, especially the US, against wearing a face cover chiefly due to misguided political activism and cultural aversion.

The result? One model suggested in October last year that more than a half-million people in the US could die from COVID-19 by the end of February, but around 130,000 of those lives could be saved if everybody were to wear masks. The latest news from the US suggests the study wasn’t inaccurate. The situation has come to such a pass that Anthony Fauci, the director of the National Institute for Allergy and Infectious Diseases in the US, “pleaded with Americans to set politics aside and wear a face mask to arrest an escalation of Covid-19 cases.”

The moral of the story is this: When it comes to dealing with the biggest pandemic in a century that is devasting lives, economies and forcing a new paradigm on us, politicizing the response is a bad idea. And India, having reached a stage where a vaccine and mass inoculation is in sight, must guard against falling into a trap that it has avoided before. There should be no politics over vaccines. The vaccine solution, which could be an important part of India’s health and economic recovery, should not be allowed to become a problem. And since India is a democracy, an important part of the process is to debate on information and facts, not misinformation, half-truths, and narratives.

The issue needs stressing as the country took a major step on Sunday towards effectively fighting the pandemic by approving two vaccines — Oxford-AstraZeneca’s Covishield, which is being manufactured in India by the Pune-based Serum Institute of India, and Bharat Biotech’s Covaxin, which has been wholly made in India with the assistance of Indian Council of Medical Research (ICMR). The formal authorization by the Drugs Controller General of India (DCGI) follows the recommendation by the Central Drugs Standard Control Organisation (CDSCO).

According to a statement released by the Union health ministry, “the Subject Expert Committee of CDSCO, that met on January 1 and 2, made the following recommendations to DCGI: grant of permission for restricted emergency use of vaccine, subject to multiple regulatory conditionalities, to Serum Institute of India, Pune, (Covishield) and grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains, to Bharat Biotech, Hyderabad (Covaxin).” Also, permission has been granted for conduct of Phase-III Clinical Trial Protocol to Cadila Healthcare.

We shall presently explore the meaning of these terminologies mean but it’s worth noting upfront, as the Indian Express points out in an editorial, that the DCGI “emergency use” approval for both vaccines are “conditional on the vaccine developers submitting details of any adverse effect to the drug regulator, every 15 days. A factsheet with safety details will also be provided to those receiving the first lot of vaccines.”

Now, though the drug regulator has approved the twin jabs, it has stressed the difference in the nature of the approvals. Covishield — developed jointly by Oxford University and Swedish-British pharma major AstraZeneca that has already been approved for use in the UK — has been recommended for emergency use in India whereas Bharat Biotech’s Covishield will carry the stamp of ‘restricted’ use. Both vaccines will be administered in two doses over 28 days and can be stored at temperatures between 2 and 8 degrees Celsius.

The difference in the approval terminology for both vaccines means that Covaxin must meet additional conditions and it won’t be the first choice. The Union health ministry statement quoted above says of Covaxin that grant of permission is being given “for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains.”

It means that Covaxin, which has not completed Phase 3 trials in India but boasts of robust data in Phase 1 and Phase 2, will be used only in emergency situations as a “backup” if a surge is detected during mass inoculation. AIIMS director Randeep Guleria told ANI that Bharat Biotech’s vaccine received conditional approval because it is still to furnish more data. It is “for an emergency situation and not emergency use authorization” that Serum Institute’s Covishield received. “Or when we have a situation where we are not sure how efficacious Serum Institute’s vaccine is going to be then as a backup we may use the Bharat Biotech vaccine”.

The question then arises, why did the drug regulator feel the need to give conditional approval even as an emergency use jab or a backup to a vaccine that hasn’t completed the double-binded Phase 3 trial? It appears that Covaxin — which will be administered only in ‘clinical trial mode’ after receiving formal consent from participants, is more effective at tackling the mutant strain of COVID-19 that has severely affected Britain and has already infected 38 patients in India.

ICMR chief Balram Bhargava told India Today that the conditional approval was given based on a consideration that the indigenously produced vaccine will prove to be better against the new strain of Covid that has infected over 50,000 people in the UK because unlike Pfizer, Covaxin is a “whole virus” vaccine.

In other words, the decision to give conditional approval to Bharat Biotech’s vaccine before the completion of Phase 3 trials was a strategic move to provide India with an option in case the Oxford-AstraZeneca option proves ineffective against the new strain. Would it have been better to delay the approval until after Phase 3 trials were complete? Possibly. However, not approving a vaccine that has shown positive signs in tackling the new strain despite availability (Covaxin was found to be safe and effective after Phase 2 and Bharat Biotech has announced that it has already submitted data on ongoing Phase 3 would have meant taking another form of risk. On balance, Covaxin is a potent weapon in India’s arsenal that would be used only if it is needed.

The government, meanwhile, has done the right thing in creating conditionalities for mass inoculation by conducting dry run across all states and its efforts have been complemented by Serum Institute that already has nearly 40-50 million doses of Covishield vaccine ready, and nearly three crore frontline workers will get the first shot in the coming weeks, followed by another 27 crore people — senior citizens and those with comorbidities — in the second phase.

This calls for even greater coordination between the Centre and states. The administrative mechanism should be ready to handle the logistical challenges that will arise, and the entire operation must be aided by big data mobilization. The effort required will be enormous, and what India cannot afford at this stage is needless political distractions that will make the task even more challenging.

Politicians need to be measured in their approaches to ensure that the debate over vaccines in India doesn’t degenerate into crude political jousting of the kind India can ill afford, least of all on a public health crisis. Samajwadi Party leader Akhilesh Yadav’s comment the other day, calling for a boycott of “BJP’s vaccines” that can’t be “trusted” is the worst form of politics. Yadav was perhaps trying to sound the dog whistle for his communal brand of politics ahead of UP elections. His comments are irresponsible and condemnable and may undermine public confidence in a vaccine that needs mass participation to do its job.

The Congress, meanwhile, is as confused as ever. Rahul Gandhi asked the prime minister last month when would India’s turn come to get vaccinated?

Now that vaccines have been approved, one Congress leader has backed Akhilesh Yadav while leaders such as Shashi Tharoor and Jairam Ramesh have accused the government of ‘bypassing’ norms.

The Centre, too, must get its fair share of the blame for announcing the vaccine without a proper explanation of the approval process. Therefore, while the approval decisions may be strategically sound, the debate became partisan and polarized. This isn’t a time to bicker. The virus hasn’t gone anywhere, and the Indian economy cannot afford yet another lockdown.



from Firstpost India Latest News https://ift.tt/38fVszX
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