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26k Adverse Events, 488 Deaths Reported in India During Covid Vaccination Drive: Data

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India has reported a little over 26,000 cases of Adverse Events Following Immunisation (AEFI) and 488 deaths linked to post-vaccination complications between January 16 and June 7, according to government data accessed by CNN-News18.

To put things in perspective, 23.5 crore doses have been administered in this period. This means AEFI cases — at 26,200 — accounted for just about 0.01% percent of the total doses administered.

In other words, over a period of 143 days, one out of every 10,000 people vaccinated against COVID-19 developed complications after receiving the jab. Two in every 10 lakh people vaccinated died.

According to the Union health ministry, AEFI cases are untoward medical occurrences that take place after immunisation. To be sure, they do not necessarily have a causal relationship with the usage of vaccines.

Benefits of vaccines outweigh the risks and the shots used in India are safe, according to experts, who also say an effective inoculation campaign is India’s best bet to end the pandemic that has killed over 3.7 lakh people in the country.

For both Serum Institute of India (SII)-manufactured Covishield and Bharat Biotech’s Covaxin, the percentage of AEFI cases in relation to the total vaccinations stood at 0.01%, according to the data.

While 24,703 cases (or 94% of the total AEFI cases) were linked to Covishield, Covaxin accounted for 1,497. To be sure, this is in context of the shots administered overall. Twenty-one crore doses of Covishield were used between January 16 — the day COVID-19 vaccinations began in India — and June 7. This number for Covaxin stood way below at two-and-a-half crore.

What are AEFI cases?

AEFI cases are of three types. Common and minor AEFI cases include fever, pain and swelling at injection site or irritability. In the next level (severe), such cases do not lead to long-term problems but can be disabling. They include pain and swelling, which spread beyond the nearest joint, or even high-grade fever. Serious AEFI cases are conditions requiring hospitalisation or leading to death or disability.

• Close to 95% (24,901) of India’s AEFI cases, the complication reported was minor.

• Nearly 2% (412) AEFI cases were severe, while 3.39% (887) cases were serious.

• A total of 2,318 cases (8.85%) needed hospitalisation.

• Of those who reported AEFI cases in India, 4,230 (16.15%) had comorbidities, or underlying health conditions.

• Fever has turned out to be one of the most common manifestation of AEFI. Over 45% (11,859) AEFI cases related to fever after injection.

Deaths after vaccination

Close to 2% (488) of the total AEFI cases (26,200) resulted in deaths, according to data from government sources. A total of 301 men and 178 women were among the dead; the data did not mention the gender of the rest of the nine people.

Of them, 457 people were given Covishield and 20 Covaxin; details of at least 11 people were not available. Again, this number has to be read in the context of very high number of Covishield shots administered overall.

• 0.000217: Percentage of deaths in relation to total doses of Covishield (two in every 10 lakh people vaccinated).

• 0.00008: Percentage of deaths in relation to total doses of Covaxin (less than one in every 10 lakh people vaccinated).

• 0.00020: Percentage of deaths in relation to total doses (two in every 10 lakh people vaccinated).

Of the 488 fatalities, 207 were admitted in hospitals. The youngest person reported to have died is a 21-year-old man from Jammu and Kashmir’s Kathua. The oldest is a 97-year-old man from Karnataka’s Kolar, according to the data.

• At least 27 of those who died were less than 39 years old.

• At least 10 of them were below 29.

Among the severe cases, blood in vomit, “sudden unconsciousness”, chest pain and difficulty in breathing were some of the symptoms. There have been a few cases of thrombocytopenia — a condition in which a patient has low blood platelet count. Platelets (thrombocytes) are colourless blood cells that help blood clot.

Earlier, an expert group investigating AEFI cases has said there is no direct causal relation established between deaths and COVID-19 vaccination.

Dileep Mavlankar, a public health expert and the director of the Indian Institute of Public Health, Gandhinagar, said there should be no doubt that vaccines were safe.

“The number of AEFIs reported is very miniscule…in crores of doses that have been administered. Vaccines remain India’s best bet to fight against COVID-19 and to avoid a possible third wave.

“Detailed investigations should to be done on each death to see whether they are related. If a pattern emerges, it should be examined. For example, some Western countries had cited women taking oral contraceptives as having higher risk of blood clotting. So some countries stopped giving the AstraZeneca (produced by SII as Covishield in India) vaccine to women in reproductive age,” he said.

AEFI and gender

AEFI cases were seen more in women (15,909) than in men (10,287), even though more men have been vaccinated in India. At the same time, 9.30 crore women have been vaccinated in the period mentioned above as against 10.91 crore men. Four AEFI cases have been reported in the third gender; 35,000 doses have been administered among them. (To be sure, the 23.5 crore total doses administered in this period and cited in the first instance included second doses.)

AEFI and age

Most such cases (7,476) have been reported in those above 51; this age group accounts for 28.53% of total AEFI cases in India. Among those between 18 and 30 years, 6,901 AEFI cases have been reported —which is 26.34% of the total cases. For those between 31 and 40, the corresponding figure is 6,360 (24.27% of total cases). And in 41-50 years, there have been 5,442 (20.77% of total) cases.

Timing of reporting AEFI after injection

A total of 25.04% (6,560) cases have been reported within 30 minutes of administrating the dose. Over 68% (17,875) AEFI cases have been reported after that. Data for the rest of the cases were not immediately available.

• A total of 23,022 (87.87%) cases have been reported after the first dose.

• A total of 3,718 cases (14.19%) have been reported after the second dose.

State-wise AEFI cases

At 4,521 (17.26%) Maharashtra reported the highest number of cases across the country. It was followed by Kerala (4,074), Karnataka (2,650), West Bengal (1,456), Uttar Pradesh (1,361), Gujarat (1,131) and Delhi (1,111)

State-wise cases in terms of per lakh doses

Mizoram reported the highest (240) cases for every one lakh doses. For Sikkim it was 114, Goa 102, and Dadra and Nagar Haveli 100.

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