Govt Panel Directs Serum Institute of India to Add Guillain-Barre Syndrome Warning as Rare Side Effect of Covishield Vaccine

New Delhi: A panel functional under the Health Ministry has recommended that the Serum Institute of India (SII) update the product information for its COVISHIELD vaccine to include rare side effects such as Guillain-Barre Syndrome (GBS) and cranial nerve palsy (affecting nerves III or VII). This decision follows a review of vaccine safety data and medical research under the Immunization Division of the Ministry of Health and Family Welfare (MoHFW).

In line with the evaluation of Adverse Event Following Immunization (AEFI) related data and published medical literature, the Signal Review Panel (SRP) for vaccines under the Immunization Division of the Ministry of Health and Family Welfare (MoHFW) has advised Serum Institute of India (SII) to include rare adverse events of Guillain-Barré Syndrome (GBS) and cranial (III or VII) nerve palsy in the SmPC (Summary of Product Characteristics) of the ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant) [COVISHIELD].

The Signal Review Panel (SRP) for vaccines under the Immunization Division of MoHFW has been set up to assess information on potential vaccine safety signals (routine and COVID-19 vaccines) using the AEFI surveillance database.

Adverse Events Following Immunization (AEFI) is defined as any untoward medical occurrences that follow immunization and that do not necessarily have a causal relationship with the usage of vaccines. These events may include one or more unfavorable or unintended signs, symptoms, or laboratory findings, which raise concern among immunization program managers, policymakers, family members of beneficiaries, and the community.

AEFIs can be common and minor (like fever, local pain, and swelling), severe (like pain and swelling that spreads beyond the nearest joint or high-grade fever), and serious AEFIs (conditions requiring hospitalization or leading to death or disability).

The AstraZeneca COVID-19 Vaccine (previously known as ChAdOx1 nCoV-19 or AZD1222) is one of several vaccines developed in 2020 for the prevention of COVID-19 caused by SARS-CoV-2.

The ChAdOx1 viral vector was developed at the University of Oxford and has been investigated as a potential vector for vaccines against another human coronavirus, Middle Eastern respiratory syndrome coronavirus (MERS-CoV).

The University of Oxford struck a development and distribution deal with AstraZeneca in May 2020 which paved the way for the vaccine's subsequent approval and usage in dozens of regions across the globe, including Canada, Mexico, the UK, the EU, and Australia, amongst others.

The AstraZeneca COVID-19 vaccine is a replication-deficient (i.e., inactivated) chimpanzee adenovirus vector—specifically, the ChAdOx1 vector—encoding a trimeric pre-fusion form of the SARS-CoV-2 spike (S) protein. Following intramuscular administration, these spike proteins are expressed locally, allowing the immune system to mount a neutralizing antibody/cellular immune response. This initial exposure and priming of the immune system subsequently provides protection against future infection.

Based on the evaluation of the AEFI-related data and published medical literature, including the Summary of Product Characteristics (SmPC) of Vaxzevria (ChAdOX AstraZeneca Vaccine) by global regulatory authorities such as UK-MHRA, European Medicines Agency (EMA), Health Canada and TGA, Australia, the Signal Review Panel (SRP) has made recommendations on the inclusion of the following rare adverse events in the SmPC of ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant) [COVISHIELD]:

• "Very Rare: Cranial (III or VII) nerve palsy following vaccination with COVISHIELD" in Section '4.8 Undesirable effects' of SmPC.

• "Very Rare/Unknown: Guillain-Barré Syndrome (GBS) following vaccination with COVISHIELD" in Section '4.8 Undesirable Effects' of SmPC

There have been reports of facial palsy as an uncommon side effect of the COVID-19 vaccine. More than 50% of the incidents arose after receiving the Oxford-AstraZeneca vaccine. Nerve palsy is a condition that occurs when a nerve is damaged or doesn't work properly, resulting in loss of feeling or paralysis in the affected area.

Guillain-Barré Syndrome (GBS) is a very rare complication after vaccination against SARS-CoV-2.A rare autoimmune condition that can be lethal, Guillain-Barré syndrome (GBS) has an unidentified cause. Only a very small percentage of persons who receive vaccinations can acquire GBS. Covishield is the brand name used in India to commercialize the Oxford-AstraZeneca COVID-19 vaccination.

Guillain-Barre syndrome is a condition in which the body's immune system attacks the nerves. It can cause weakness, numbness, or paralysis. Weakness and tingling in the hands and feet are usually the first symptoms. These sensations can quickly spread and may lead to paralysis. In its most serious form, Guillain-Barre syndrome is a medical emergency. Most people with the condition need treatment in a hospital.

Guillain-Barre syndrome is rare, and the exact cause is not known. But two-thirds of people have symptoms of an infection in the six weeks before Guillain-Barre symptoms begin. Infections can include a respiratory or a gastrointestinal infection, including COVID-19.

In view of the above, the signal review panel has opined to Serum Institute of India to update the SmPC and Prescribing Information (PI) as per recommendations of SRP and submit the same to this Directorate.