From insisting on seeking legal protection to waiving clinical trials, Pfizer’s application to the Comptroller General of Drugs of India (DCGI), seeking permission for the Emergency Use Authorization of its COVID-19
vaccine, it has too many buts and yes.
The committee of subject matter experts constituted by DCGI is expected to meet this week to work on the modalities of Pfizer’s proposal. The mRNA vaccine from Pfizer and BioNtech, the first mRNA vaccine to gain approval in the history of medical science, has shown efficacy levels in excess of 90%. He applied for the US before the DCGI on December 4. The pharmaceutical giant has approvals in the UK and Bahrain.
INSISTENCE ON INDEMNITY
The UK has allowed emergency use authorization to Pfizer, while also choosing to provide legal protection for the company. Essentially this means that the UK government will take responsibility for dealing with any serious adverse outcomes from the Pfizer vaccine. The UK DHSC (Department of Health and Social Care) has confirmed that it would add this vaccine to the list of vaccines covered by the Damages and Payments Act, which means that the government will pay a fixed amount for anyone who develops a disability permanent as a result of vaccination.
But will India, a developing country, be in a position to provide Pfizer with legal protection of this nature? This has become a major roadblock to giving Pfizer a license with the government unwilling to bear this burden. “We are aware of claims for compensation from vaccine manufacturers, such as in the event of serious adverse events after licensing. What is the government’s position on such claims? These are open questions,” he says Malini Aisola, Co-coordinator, All India Action Against Drugs Network (AIDAN).
ABANDON CLINICAL TRIALS
Pfizer also wants to skip the bridging studies in India. Isn’t this unusual? No, experts say. “Vaccines that have already gone through large-scale phase 3 clinical trials (involving tens of thousands of people) do not necessarily need to undergo the same trials in every country that wants to use that particular vaccine,” says Dr. Rajeev Jayadevan, former president of the Indian Medical Association, Cochin.
“This will not only delay procedures, but conducting such trials will be difficult as other vaccines will be available by then,” he says.
Experts say that in such an environment, a placebo-controlled trial will no longer be possible. The reason is that the administration of a placebo can no longer be justified if the government already recommends a vaccine. “This is a tricky situation in medical ethics,” he adds.
But the government has so far not allowed the bridge studies to be skipped. Not in the case of Sputnik V, the Russian vaccine undergoing phase II, III trials in India, not even AstraZeneca, called COVISHIELD here, which is now being tested in the Indian population.
“The government of India has so far held a position of principle that vaccines will be approved in India only after the data is collected through local / bridge studies. It remains to be seen whether the government relaxes its position regarding to local trials, not just for Pfizer but other potential applicants, “says Aisola.
DATA NOT AVAILABLE
The vaccine data so far has only been limited to the company’s versions. “While there is no reason not to believe such press releases, physicians and scientists will always want to see peer-reviewed articles published in reputable journals first. For example, scientific journals will have subgroup analysis, through from which any potential problems with the identified vaccine can be resolved, “says Dr. Jayadevan.
What needs to be understood from the data is how effective these vaccines are in vulnerable groups where mortality and the possibility of serious complications are substantially higher. Therefore, demonstrating that efficacy exists only among a healthy young adult population will not be of much value here.
These problems won’t be obvious when you look at the overall numbers. The side effects of vaccines should be viewed differently from the side effects of other medications. Therefore, any adverse outcome should be taken very seriously, more than any other category of medication.
STORAGE AND COSTS
The twin dilemmas facing India; the vaccine is priced at $ 39. It’s an mRNA vaccine and it comes with the cost of novelty.
Because it is so expensive, the chances of it going down the drain if not stored properly is a concerning proposition. While ensuring a longer shelf life of 6 months will require storage temperatures of -78 degrees, Pfizer says the vaccine can be stored at the normal 2 to 8 degrees and will have a shelf life of 30 days, and will be refrozen every 5 days. . It may be an option for urban India, but certainly not an option for interiors.
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