NEW DELHI: As 23 elderly people died in Norway after receiving Pfizer-BioNTech Covid-19 vaccine, experts in India underlined the need to closely monitor adverse events on a day when a massive vaccination drive against coronavirus kicked off in the country.
In Norway, where about 30,000 people have received the mRNA vaccine since the end of December, a cautionary advisory has now been issued against vaccinating elderly people above 80 years, saying those with a short remaining lifespan may not greatly benefit from the vaccine.
The Scandinavian country has also said that Covid-19 vaccines may be too risky for the very old and terminally ill.
As per the details available, of the 23 deaths -- mostly in people over 80 years -- reported shortly after vaccinations, 13 have been autopsied, and the results have suggested that that common side effects such as diarrhoea, fever, and nausea may have contributed to severe reactions in frail, elderly people.
The Covid-19 vaccine by Pfizer-BioNTech was the first one to receive emergency use approval in the developed countries after showing the efficacy of over 95% in late-stage trials. International reports said that Pfizer and BioNTech are now working with the Norwegian authorities to investigate the deaths in Norway.
Pfizer, however, said in a statement that the Norwegian regulator discovered "the number of incidents so far is not alarming and in line with expectations”.
Meanwhile, experts back home said that such lessons from abroad could be particularly crucial for India where the number of beneficiaries is going to be much higher than most other countries in the world.
“It would be important to closely monitor adverse events of special interest. AESI are a group of safety events that have been identified as important safety signals and a detailed mechanism for tracking, monitoring, and reporting have been listed in the WHO vaccine safety manual,” said public health expert Oommen John.
“Knowing background rates of safety events is also very important to estimate if there are increased incidence of events are attributed to the vaccine or not.”
A virologist with the Translational Health Science and Technology Institute said that minutely following adverse events though a proper mechanism was important in India as Covaxin, one of the vaccines rolled out, has not completed the trials.
“Also, the platform used by Covishield is known to cause neurological disorders in very few people who get vaccinated—so it's important to track what is the impact of vaccines in a real-world situation outside clinical trials,” he said.
The Indian government has declared its intent to vaccinate those above 50 and others with serious comorbidities—numbering about 27 crore—once nearly 3 crore healthcare and frontline workers are immunised against Covid-19.