S. MARGARET Keenan will be a quizmaster’s delight in the coming years. The 90-year-old grandmother became the first person in the world to get the historic Pfizer/BioNTech jab against coronavirus.
The “landmark moment” has kickstarted first medicinal fight against the virus that has brought the world on its knees since last nine months. The world will now watch with bated breath at the results of the doses in the United Kingdom to shape fight with available vaccines.
The first vaccine has brought great cheer in the otherwise desolate scenario. With many other pharma companies in the process of getting regulatory approval for their vaccines a sense of security has enveloped the affected countries. It is indeed a remarkable achievement for the scientists and medical fraternity to bring a vaccine in less than a year of the pandemic outbreak.
Success of the pharma companies also underlines how collective deliberation on an issue of global interest can help mankind in finding solution to any problem.
Sooner the vaccines are in market better it will be for people but the situation also calls for absolute transparency in the process and results of the clinical trials. Peer reviews of some vaccines have left some key questions unanswered. The Pfizer/BioNTech vaccine and Moderna’s shots have got regulatory approval in some countries but more analysis will be needed to see how it works in the elderly people who are among those
at higher risk from the pandemic.
Lack of transparency on vaccine safety and efficacy will be a grave mistake, for, the pandemic cannot be dealt with by developing a hasty, half-baked medicine. In India, the situation must be handled with extreme care given the high caseload of coronavirus positive patients.
Among the most affected nations, India has managed the situation quite well and is only the second country after Argentina to have stopped a second wave of the virus. Now, at a critical juncture of getting its own vaccine, India needs to channel all its resources to make the regulatory process totally transparent as any slip-up may result in a catastrophe of unprecedented proportions.
Risk profile of the vaccines for emergency use approval is necessary before immunisation process begins in India. Prime Minister Mr. Narendra Modi’s announcement that an Indian vaccine will be in market in a few weeks has raised hopes of the entire country.
The Union Ministry of Health and Family Welfare, too, has gone public on different stages of clinical trials of as many as eight vaccines. The Serum Institute of India (SII) has already sought approval for emergency use of authorisation for AstraZeneca-Oxford Covishield vaccine but details of the trials in India are yet to come out. That makes it necessary for the drug regulatory authority to seek each and every detail of the clinical trial process adopted by the makers.
Rushing in with a vaccine without weighing the efficacy levels is fraught with danger. Any adverse reaction may result in loss of people’s confidence in getting vaccinated. Data has already shown people’s hesitancy in getting inoculated.
The high number of respondents showing unwillingness for the vaccine is selfexplanatory for the Government and health machinery in India.
They need to win people’s faith with a potent vaccine that clears all parameters of safety and efficacy.
Fast-tracking the process for the purpose of fulfilling a promise is not advisable at the moment when all details of the phase 3 clinical trials are not available. It is important for those seeking emergency use authorisation for their vaccine to also share the safety and efficacy data immediately and the regulators to set a strict protocol before granting approval. The country can wait for a few more weeks for a robust and effective medicine.
It is not a race among nations to garner some brownie points. The issue is about public safety. And by the way, history has already been made in the UK.
