Reports of four people who were a part of Pfizer-BioNTech's COVID-19 mRNA vaccine trials in the US, developing Bell's Palsy (temporary facial paralysis) have raised concerns about the speed at which the COVID-19 vaccines were developed and are available for use.
However, the US Food and Drugs Administration (FDA) on December 10, in a meeting of the Vaccines and Related Biological Products Advisory Committee claimed that there was no causal relationship between the vaccine and the emergence of Bell's Palsy. It later approved emergency use authorization for the vaccine on December 11. Medical professionals in the US have begun receiving the vaccine from December 14.
Bell's Palsy is a temporary facial paralysis caused by swelling of facial nerves that controls the muscles on one side of the face. Its exact cause is unknown. Symptoms are suddenly observed between a 48-72 hour window and recovery takes over a few weeks. Symptoms such as drooping of the mouth, drooling, inability to close eye (causing dryness of the eye), and excessive tearing in one eye, facial pain or abnormal sensation, altered taste and intolerance to loud noise. could lead to significant facial distortion. It can be treated with the help of steroids.
Vaccine induced Bell's Palsy was earlier reported in 2002 with the influenza vaccine. The World Health Organisation had then recommended that participants receiving any intranasal vaccine should be followed up for three months to see if cases of the facial distortion arise.
Pfizer-BioNTech vaccine that is now being administered in both US and UK has even sought for approval from the Indian drug controller. However, it has not conducted any trials in the country and needs to be stored at temperatures below -70ºC. India's current cold chain infrastructure is still not equipped to store this vaccine at its assigned temperatures.
Furthermore, the pharmaceutical giant asked for more time from the Subject Expert Committee at the Central Drugs Standard Control Organisation when it was asked to appear and present its data for approval in the second week of December.
The recent case of four people developing Bell's Palsy, however, has led to many people who are opposing vaccines in India to raise questions about the approval of the vaccine in the country. The US FDA has recommended guidelines to ensure that thorough surveillance is conducted to check for any cases of Bell's Palsy once the vaccine is deployed to a larger population. The UK has reported allergies but no severe adverse events, yet.
While the vaccine is still to be approved in India, health experts have designed a protocol for the management of any adverse events. After receiving a shot of whichever COVID-19 vaccine is approved, the recipients will be asked to wait for 30 minutes as they will be kept under observation for any immediate side effects.
BOOM spoke to Dr. Om Shrivastav, Infectious disease expert at Jaslok Hospital, and member of the Maharashtra COVID-19 task force to understand how to alleviate COVID-19 vaccine fears and hesitancy that are emerging in the minds of people due to the reports of side effects.
"If India decides to approve this vaccine, health workers and the elderly should opt for the vaccine. The efficacy results and the data show that the vaccine is doing what it intends to do. Currently, a vaccine is important and when you compare, the efficacy and safety data is significantly better than the side-effects," Dr. Shrivastav explained.
The infectious disease expert also added that people can opt for the other two vaccines too once their results are shared and they are seen to be effective. Serum Institute and Bharat Biotech have been asked to reappear with more data to receive approval for emergency use in India.