A government panel studying adverse effects after COVID-19 immunisation has confirmed the first death due to anaphylaxis following vaccination, reports said on Tuesday.
The National AEFI Committee however, said that all benefits of vaccination are overwhelmingly greater than the small risk of harm and as a measure of utmost precaution, all emerging signals of harm are being constantly tracked and reviewed periodically.
Separately, the Centre also said that the risk of death following vaccination is negligible compared to the known risk of dying due to COVID-19.
It also said that of the total 69,995 vaccination centres so far classified by states on Co-WIN as rural or urban, 71 percent are located in rural areas. COVID-19 vaccination per million population in tribal districts (1,73,875) is higher than the national average (1,68,951), the health ministry said.
In a press briefing on the COVID-19 situation in the country, the Union health ministry said a total of 26.05 crore vaccine doses have been administered across the country till date. According to India Today, joint secretary Lav Agarwal, said the Co-WIN platform has played a crucial role in tracking vaccinations and adverse events following immunizations (AEFIs).
Agarwal said there has been an almost 85 percent decline in daily COVID-19 cases since the highest reported peak on 7 May and currently, there are 20 states and UTs where active cases are less than 5,000.
He further said that a sharp decline of 78 percent has been noted since the highest reported weekly coronavirus case positivity rate of 21.4 percent, which was recorded May 4 and 10 between during the second wave.
India on Tuesday reported a single-day rise of 60,471 new coronavirus infections, the lowest after 75 days, taking the total number of cases to 2,95,70,881 while the toll rose to 3,77,031 with 2,726 fresh deaths, according to the health ministry's data updated in the morning.
Active cases declined by59,780 to 9,13,378 and comprise 3.09 percent of the total infections, while the national COVID-19 recovery rate has improved to 95.64 percent, the ministry said. The number of people who have recuperated from the disease surged to 2,82,80,472, the data showed.
The daily positivity rate has dropped to 3.45 percent and has remained below five percent for eight consecutive days, the ministry said, adding the weekly positivity rate has declined to 4.39 percent.
Assam and Jharkhand extended restrictions with relaxations while Puducherry has extended lockdown till the midnight of 21 June with additional curbs.
During the briefing, NITI Aayog member VK Paul cautioned that social distancing must be maintained amid unlocking and the opening up of markets. "Responsibility and discipline are two important things for unlocking," News18 quotes him as saying.
Govt panel confirms first post-vaccination death
According to a report by the National AEFI Committee, a 68-year-old man died due to anaphylaxis (severe allergic reaction) after being vaccinated on 8 March, 2021.
"It is the first death linked to COVID-19 vaccination due to anaphylaxis. It re-emphasises the need to wait for 30 minutes at the inoculation centre after receiving the jab. Most of the anaphylactic reactions occur during this period and prompt treatment prevents deaths," Dr NK Arora, chairperson, National AEFI committee, told news agency PTI.
The committee examined five Serious Adverse Events Following Immunisation cases that took place on 5 February, eight cases on 9 March and 18 cases on 31 March.
Of the 31 causally assessed cases, 18 were classified as having inconsistent causal association to vaccination (coincidental - not linked to vaccination), 7 were classified as indeterminate, 3 cases were found to be vaccine product-related, 1 was anxiety-related reaction and two cases were found to be unclassifiable, the government panel report said.
In the two other cases of anaphylaxis, two persons were given vaccines on 19 and 16 January and both of them were hospitalised and have since recovered.
As per data in the first week of April, the reporting rate is 2.7 deaths per million vaccine doses administered and 4.8 hospitalisations per million vaccine doses administered, the report stated.
The panel said mere reporting of deaths and hospitalisations as serious adverse events does not automatically imply that the events were caused due to vaccines. Only properly conducted investigations and causality assessments can help in understanding if any causal relationship exists between the event and the vaccine, the report said, adding for causality assessments, priority has been given to death cases.
Separately, the health ministry termed as "incomplete" and of "limited understanding" media reports which stated that 488 deaths between 16 January and 7 June following vaccination were linked to post-COVID complications, and highlighted that the vaccination coverage during this period was 23.5 crore.
The number of deaths reported following COVID-19 vaccination in the country is only 0.0002 percent of the 23.5 crore doses administered, and this is within the expected death rates in a population, it said.
In a population, deaths occur at a certain rate. The crude death rate in 2017, according to sample registration system (SRS) data, was 6.3 per 1,000 persons annually, the ministry said.
It is also important and pertinent to note that the mortality rate for those testing positive for COVID-19 is more than one percent and vaccination can prevent these fatalities, it said. "Therefore, the risk of dying following vaccination is negligible as compared to the known risk of dying due to COVID-19," the ministry stated.
The Union health ministry said that 128 out of 176 tribal districts performing better than all India vaccination coverage and also witnessing more walk-ins. As per the data available on Co-WIN as on 3 June, the gender ratio for people vaccinated is also better in tribal districts.
These statistics bust misconception about the rural-urban divide as the Co-WIN system offers a flexible and inclusive framework for facilitating vaccination recording in rural areas, and especially in remote parts of the country, the ministry underlined.
As on 13 June, out of the 28.36 crore beneficiaries registered on Co-WIN, 58 percent beneficiaries have been registered in the on-site mode, the ministry said. Out of the total 24.84 crore vaccine doses recorded on Co-WIN as on 13 June, 19.84 crore doses have been administered through onsite or walk-in vaccination, the ministry said.
From 1 May till 12 June, out of the total 1,03,585 COVID Vaccination Centres [CVCs] providing vaccination services, 26,114 are operated at the Sub-Health Centres, 26,287 at the Primary Health Centres and 9,441 at the Community Health Centres, amounting to 59.7 percent of the total vaccination centres.
'Covaxin suppy price to Centre non-competitive'
Also on Tuesday, Bharat Biotech said the supply price of Covaxin to the Central government at Rs 150 per dose is a non-competitive price and not sustainable in the long run. Hence a higher price in private markets is required to offset part of the costs, the vaccine maker said in a statement.
Fundamental business reasons ranging from low procurement volumes, high distribution costs and retail margins, among few others, contribute to higher pricing of Covaxin to the private sector, Bharat Biotech said, justifying the higher price when compared to other COVID-19 vaccines available for private players.
During the press briefing, Paul said Novavax vaccine's efficacy data is promising and the data available in public domain also indicates that it is safe and highly effective.
"What we are learning from the available data that this vaccine is very safe and it is highly effective but what makes this vaccine relevant for today is the fact that this vaccine will be produced in India by the Serum Institute of India," Paul said.
The preparatory work has already been accomplished by the Serum Institute and it is also conducting a bridging trial, which is in advanced stages of completion, he said.
"I am also hoping that they will also start trials on children which is of a special interest to all of us. The pace of vaccination should see a renewed energy from next week onwards when we will realign our and states' efforts," he added.
The health ministry said those in the 1-20 age group accounted for less than 12 percent of the coronavirus cases recorded during both the waves, countering reports that children and the younger population were more affected in the second wave.
Amid fears about the possibility of children getting more affected if a third wave comes, the government said there appears to be no substantial evidence to indicate there will be severe infection among them but then highlighted that people of all age groups need to stay vigilant and follow precautions.
'Delta plus not yet variant of concern'
Paul also said the Delta plus variant, which has been there since March in Europe, is not yet a 'variant of concern' and noted that its presence has to be assessed and tracked in the country.
Separately, the health ministry said genome sequencing by the Indian SARS-CoV-2 Genetics Consortium helped in detection of 'variants of concern' in real-time and it was also shared with states, highlighting that the turnaround time was 10 to 15 days.
The ministry said that the effect of known 'variants of concern' (VoCs) on disease transmission and severity is already established but for new mutations or variants under investigation, and for correlation of genomic mutations with epidemiological scenarios and clinical perspective, it is important to monitor epidemiological trends of cases, clinical severity and proportions of samples with genomic variants, it said. These have to be done over a few weeks to generate scientifically valid evidence.
Referring to some media reports which alleged low quantum of sequencing in the country and significant lag between sample collection and sequence submission into the database for pattern detection and actionable alerts to governments, the ministry said, "It is clarified that a sampling strategy is based on the country's objectives, scientific principles and WHO (World Health Organisation) guidance documents. Accordingly, the strategy has been reviewed and revised from time to time."
Meanwhile, with new cases on the decline in the country, Jharkhand and Assam extended restrictions till 24 and 22 June respectively but eased the curbs.
An order by the Assam State Disaster Management Authority divided the state into three categories depending upon the improvement in the pandemic situation. Accordingly, the curfew duration in Kamrup Metropolitan, has been relaxed by one hour. It would start at 2 pm and continue till 5 am the next day.
South Salmara, Majuli, Bongaigaon, Chirang, Udalguri, West Karbi Anglong, Dima Hasao and Charaideo districts, where the positive cases are less than 400 cumulatively in the last 10 days, the lockdown-like restrictions have been relaxed and movement of individuals will be allowed from 5 am to 5 pm.
"Districts where the total number of cumulative cases and per day cases are still showing persistently high numbers, especially Cachar, Tinsukia, Dibrugarh, Sonitpur and Nagaon, will be under close watch till 21st June, 2021. In case there is no improvement in the COVID status in these districts, stricter restrictions may follow," the ASDMA said.
All the other districts will continue to be under the existing set of restrictions. Regarding the functioning of government and private offices, shops, restaurants and other commercial establishments, the ASDMA said all such places have to close down one hour prior to starting of the curfew, which has different timing in different districts.
The Jharkhand government allowed opening of shopping malls and departmental stores till 4 pm. Inter-state and Intra-state bus transport shall remain prohibited except for the buses specifically used by the district administration till 21 June morning. E-passes will be mandatory for inter-state and inter- district movement in private vehicles but for movement within the district, no e-passes will be required.
Religious places will remain closed for the devotees like earlier and so will educational institutions. The governemnt has allowed opening of all government and private offices till 4 pm with one-third of human resources.
The Uttar Pradesh government on Tuesday decided to give relaxation of two more hours during the night 'corona curfew' across the state from 21 June. From next Monday, the night curfew hours will be effective from 9 pm to 7 am.
Besides, restaurants and malls can be opened at 50 percent capacity with strict compliance of COVID protocol, Additional Chief Secretary (Information) Navneet Sehgal said in a statement. Permission will also be given to open parks and operate street food kiosks, etc. and setting up COVID help desks at these places will be mandatory. The detailed guidelines regarding the new system would be issued in time, Sehgal said.
The Punjab govt allowed restaurants, coffee shops, fast food outlets,cinema halls and gyms to operate at 50 percent capacity beginning Wednesday, subject to all their employees having received at least one dose of vaccination. Also, 50 people are allowed at weddings and cremations.
Air conditioned buses can also ply with 50 percent occupation. Bars, pubs and 'ahatas' (tavern) shall, however, continue to remain closed, the statement said.
Under the fresh guidelines, which will remain in effect till 25 June, daily night curfew will be in place from 8 pm to 5 am and weekend curfew will be imposed from 8 pm on Saturday up to 5 am on Monday across the state. District authorities have been asked to determine opening timings of non-essential shops on the basis of the local situation, while ensuring that crowds are avoided.
The Puducherry government has extended the lockdown with additional restrictions, with effect from 14 June midnight.
As per the orders issued on Monday night, parks, gardens, cinema houses, multiplex, auditorium, museum and libraries would remain closed and gatherings and congregations in any form were also prohibited. Also, cultural festivals, sports activities and other entertainment were strictly prohibited, it was stated.
All shops, commercial and business establishments would however be permitted to do business from 9 am to 5 pm with certain conditions.
According to the order, vegetable stalls and fruit shops would be permitted to function from 5 am to 5 pm each day. Restaurants and bar facilities within the hotels, lodges and guest houses and also other standalone eateries are permitted to operate with 50 percent capacity up to 5 pm and tea shops and juice stalls have been permitted to operate up to 5 pm by following Covid norms.
The government said retail sale of liquor and arrack is permitted from 9 am to 5 pm.
Goods transport would remain permitted and private and government public passenger transport buses, autos, taxies are also permitted to operate up to 5 pm on all days.
The order said beach road would be open for the public from 5 to 9 am during the lockdown period. The walkers should compulsorily wear masks and maintain social distancing norms. All places of worship would be open to people for prayers up to 5 pm.
With inputs from PTI