Is 20-day window enough to monitor Covid-19 vaccine side effects, experts ask

The government has put the onus of reporting AEFIs on the people

Health experts have raised concerns over the Union health ministry's advisory asking people to report any side effects of vaccines within 20 days of receiving a dose. They have called the move a knee-jerk reaction in the backdrop of reports of Covid-19 deaths of people who had already taken one or both jabs. This is the first time the government has provided some information about clots caused by vaccines.

Since the vaccines have been developed in a short time, AEFI data is crucial, say experts. Pic/Ashish Raje

The Centre spelt out the details about AEFI data collection through a directive dated May 18.

Dr Wiqar Shaikh, Professor of Medicine, Grant Medical College and Sir J.J. Group of Hospitals, said the data related to "Adverse Events following Immunisation" in India is at best partial and it is difficult to believe the unusually low incidence - termed as "minuscule" in the directive. By contrast, Western countries have reported many AEFIs including blood clotting, allergic reactions as well as deaths, particularly those due to anaphylaxis, he said.

Dr. Shaikh emphasized that Western nations have an extensive online mechanism for the public to report AEFIs, something which is missing in India. Compared to their 6-week window for follow-up, he said 20 days appear too less, he said, adding that there should be no time limit for reporting AEFIs.

The expert underscored the importance of AEFI data saying vaccines have been developed within 6 months and lack long-term clinical trials and that all have been approved only for emergency use.

On putting the onus of reporting on the people, he said, "One wonders how a primary health centre or even a makeshift vaccine centre could help in AEFIs, particularly in rural areas. India needs an efficient portal to report AEFIs and such patients need to be urgently directed to specialist centres."

He also expressed concerns over the government's silence over post-vaccination deaths in the country and those who contracted the disease despite both doses. "These facts cannot be brushed under the carpet in a pandemic. The government's advisory for a 20-day follow-up for AEFIs looks to be a knee-jerk reaction to reports on post-vaccination deaths."

Dr Ketan Vagholkar, Professor of Surgery at D Y Patil Medical College, said it's necessary to closely monitor people after vaccine shots to report the early and delayed symptoms and signs related to Covid-19 which may occur after the first or the second dose.

Dr Jacob John, Vellore-based virologist

"Moreover, there should be a uniform consensus deciding the interval between the two doses which could best be based on titration of protective antibody levels in the individuals after vaccination. This will allay the uncertainty pertaining to vaccination," said Dr Vagholkar.

Dr Subhash Hira, Professor of Global Health at the University of Washington-Seattle, said there is a general consensus that AEFI surveillance for vaccines should be kept for 30 days, barring rare cases.

He said countries like the UK and France have developed real-time, user-friendly AEFI reporting portals for longer surveillance. "The latter surveillance has a distinct new advantage i.e. to capture Covid-19 re-infections and deaths among those who have received on or both vaccine shots and classify these under long-term adverse effects category. For example, recent Covid-19 deaths of high-profile doctors like Dr K.K.Agarwal and Dr Luthra who got re-infected after two shots. These adverse effects need to be captured for a longer term in the proposed national real-time Covid-19 portal," he said.

Vellore-based virologist Dr Jacob John "I am not privy to decision-makers and they do not tell us any logic or reasoning of various decisions and instructions, like interval between doses." He said, "There is no ‘harm' delaying but when there is short supply let more get the first dose and in due course a second dose will become available. Here harm is a lower immune response, but there is potential harm as shown below. Immunity will be good even if the second dose is delayed for months. But protection delayed can be protection denied for those who get Covid-19 and die waiting for the second dose."

Dr Jacob added, "If death occurs in spite of two doses the information is extremely disturbing since we have no way of knowing if the vaccine worked or not," said Dr Jacob.

The expert added, "In other countries after 2 doses, protection against fatal Covid-19 is 100 per cent. The government should clarify this with actual data but the general tendency seems to be to sweep all
inconvenient data under the carpet."

Categories of AEFI

>> Product-related or ingredient-related - can last up to 12 weeks
>> Vaccine quality defect-related is short-lasting - over 30 days
>> Immunisation error-related reaction - less than 30 days
>> Immunisation anxiety-related - less than 15 days
>> Coincidental events like fever, irritability, pain and redness at site of injection - lasting for more than 3 days