Most vaccine adverse reactions not serious in nature

FILE PHOTO: A woman holds a small bottle labelled with a “Coronavirus COVID-19 Vaccine” sticker and a medical syringe in this illustration taken October 30, 2020. REUTERS/Dado Ruvic/File Photo

All individuals who have had an anaphylactic reaction after the first dose can avoid the second dose of the Covid-19 vaccine

Lhakpa Tshering

The National Adverse Event Following Immunization (AEFI) Committee in its report submitted to the Ministry of Health (MoH) said that most adverse effects reports following Covid-19 vaccination are considered non-serious.

The committee noted that as of 1 May 2021, 9,402 minor side effects were reported following the administration of the Covishield vaccine in 480,498 individuals, which is over 90 percent of the eligible population, since mass inoculation began over two months ago.

Of these various degrees of side effects, the most commonly reported adverse events were headache with 34 percent followed by fever and nausea reported as 17 percent and 12 percent of 8,644 AEFI reports respectively as of 19 April 2021.

According to the committee, four cases where the individuals received two doses of the vaccine have also been reported. However, none of them reported any adverse effects to date.

The committee has also completed an in-depth case review of 48 serious and severe events reported from 14 dzongkhags which the committee said only 11 cases were managed as anaphylaxis – serious allergic reaction – in which 10 met the definition of anaphylaxis.

However, following detailed discussion on these cases, one case was discarded as a case of anaphylaxis while it categorized one as level-I and nine were level-II anaphylaxis while also noting it was significantly higher than what was reported in the literature so far.

Clinical microbiologist and a member of the health ministry’s national immunization technical advisory group (NITAG) and technical advisory group (TAG), Dr Tshokey said that all individuals with anaphylaxis can avoid the second dose of Covid-19 vaccine.

“If they have had an anaphylactic reaction after the first dose, they are certainly at risk of reactions after the second dose,” he said. “If possible, better not to get it if they cannot take the risk.”

However, should they get the second shot on the ground of going abroad and so on, he said that they will ideally be given in the hospital settings that have resuscitation equipment in the presence of doctors and medical specialists.

“Given that we have only a few of those cases, they are manageable in getting the second shot,” Dr Tshokey said. “We can give them full attention.”

Other minor cases, he said, will be given the second dose like the rest of the eligible population to be fully vaccinated. “The term fully vaccinated applies to people who have received both the vaccine and two weeks after the second dose,” he added.

Of the total 48 serious AEFI, six succumbed to the illness including two sudden deaths. But the deaths could not be directly attributed to Covid-19 vaccination as it occurred with significant comorbidities.

“The four coincidental deaths were acute exacerbation of bronchial asthma, hepatic, encephalopathy, hemorrhagic stroke, and extradural hematoma secondary to head injury following alcohol withdrawal seizures,” reads the committee summary.

Other serious AEFI cases include 10 alcohol withdrawal seizures, seven seizures, four strokes, one deep vein thrombosis, and three acute exacerbations of bronchial asthma after receiving their first doses of the vaccination against the coronavirus infection.

MoH has put in place a robust procedure to monitor and report AEFIs. Bhutan’s AEFI surveillance is noted to be robust compared to many in the region. Given this robust system, the country has so far reported the highest rates of AEFIs in the region.

This is because a daily reporting including zero reporting of AEFIs from all vaccination posts was done. And they also made provision for people to report their AEFIs through dedicated hotlines.

They immediately reported serious AEFIs in Bhutan Vaccine System (BVS) and put in place the need to investigate within 72 hours.

The Regional Immunization Technical Advisory Group (RITAG) and NITAG monitored the AEFIs reported on a real-time basis and reviewed the AEFIs daily.

Findings and recommendations

Using BVS was noted to be instrumental in allowing real-time reporting of AEFIs and the dashboard on AEFIs was found to be very useful for providing a snapshot of the AEFIs reported.

However, the National AEFI Committee pointed out several issues and recommended improving the system for functional and real-time.

Given the significant number of data duplication in the first campaign in the BVS system, the committee has recommended updating or incorporating changes in the system to prevent data inaccuracy and duplication.

They observed the establishment of RITAG at the two regional referral hospitals to be good practice in assisting the NITAG in dealing with AEFIs in real-time and also in doing a causality assessment at the earliest.

However, concerns were raised in terms of members of the RITAG being able to dedicate full time due to competing needs for attention for the routine duties that members of RITAG need to fulfill.

The deployment of medical doctors to the various vaccination posts around the country was found useful for monitoring and management of AEFI. And their presence boosted the confidence of the peripheral health care workers and was also useful in providing medical care for other ailments.

However, to improve further on their service delivery, it was recommended the allocation of the doctors in the field be done, take into consideration the human resource available in the field, and prioritized.

Concerns were also raised concerning the mixed messaging regarding the eligibility of vaccination for pregnant and lactating women.

With over 400 pregnant women receiving the Covishield vaccine during the recent campaign, Vaccine-Preventable Disease Program was recommended to actively follow up with all these women and record the outcome of the pregnancy.

Drugs Technical Advisory Committee (DTAC) and Drug Regulatory Authority (DRA) were recommended to review emerging evidence on the use of the vaccine in pregnant and breastfeeding mothers and issue directives to the government.

Concerns were discussed regarding the inability of being able to investigate serious AEFIs because of human resource constraints during such a campaign mode vaccination program.

It was also observed that some of the vaccination posts didn’t have the complete set of AEFI kits and some contents of the kits were expired.

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