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

Health experts have raised concerns over the Union health ministryrsquos advisory asking people to report any side effects of vaccines within 20 days of receiving a dose They have called the move a kneejerk reaction in the backdrop of reports of Covid19 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 vaccinesSince the vaccines have been developed in a short time AEFI data is crucial say experts PicAshish RajeThe Centre spelt out the details about AEFI data collection through a directive dated May 18Dr Wiqar Shaikh Professor of Medicine Grant Medical College and Sir JJ Group of Hospitals said the data related to ldquoAdverse Events following Immunisationrdquo in India is at best partial and it is difficult to believe the unusually low incidencemdashtermed as ldquominusculerdquo 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 saidDr 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 6week window for followup he said 20 days appear too less he said adding that there should be no time limit for reporting AEFIsThe expert underscored the importance of AEFI data saying vaccines have been developed within 6 months and lack longterm clinical trials and that all have been approved only for emergency useOn putting the onus of reporting on the people he said ldquoOne 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 centresrdquoHe also expressed concerns over the governmentrsquos silence over postvaccination deaths in the country and those who contracted the disease despite both doses ldquoThese facts cannot be brushed under the carpet in a pandemic The governmentrsquos advisory for a 20day followup for AEFIs looks to be a kneejerk reaction to reports on postvaccination deathsrdquoDr Ketan Vagholkar Professor of Surgery at D Y Patil Medical College said itrsquos necessary to closely monitor people after vaccine shots to report the early and delayed symptoms and signs related to Covid19 which may occur after the first or the second doseDr Jacob John Vellorebased virologistldquoMoreover 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 vaccinationrdquo said Dr VagholkarDr Subhash Hira Professor of Global Health at the University of WashingtonSeattle said there is a general consensus that AEFI surveillance for vaccines should be kept for 30 days barring rare casesHe said countries like the UK and France have developed realtime userfriendly AEFI reporting portals for longer surveillance ldquoThe latter surveillance has a distinct new advantage ie to capture Covid19 reinfections and deaths among those who have received on or both vaccine shots and classify these under longterm adverse effects category For example recent Covid19 deaths of highprofile doctors like Dr KKAgarwal and Dr Luthra who got reinfected after two shots These adverse effects need to be captured for a longer term in the proposed national realtime Covid19 portalrdquo he saidVellorebased virologist Dr Jacob John ldquoI am not privy to decisionmakers and they do not tell us any logic or reasoning of various decisions and instructions like interval between dosesrdquo He said ldquoThere is no lsquoharmrsquo 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 Covid19 and die waiting for the second doserdquoDr Jacob added ldquoIf death occurs in spite of two doses the information is extremely disturbing since we have no way of knowing if the vaccine worked or notrdquo said Dr JacobThe expert added ldquoIn other countries after 2 doses protection against fatal Covid19 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 carpetrdquoCategories of AEFIgtgt Productrelated or ingredientrelated mdash can last up to 12 weeksgtgt Vaccine quality defectrelated is shortlasting mdash over 30 daysgtgt Immunisation errorrelated reaction mdash less than 30 daysgtgt Immunisation anxietyrelated mdash less than 15 daysgtgt Coincidental events like fever irritability pain and redness at site of injection mdash lasting for more than 3 days