Africa: Statement by the Covid-19 Subcommittee of the WHO Global Advisory Committee on Vaccine Safety (GACVS) on Guillain-Barré Syndrome (GBS) Reports Following Vaccines Against the Covid-Adenovirus Vector 19

Others



[ad_1]

On July 13 and 20, 2021, the COVID-19 subcommittee of the WHO Global Advisory Committee on Vaccine Safety (GACVS) met virtually to discuss rare cases of Guillain-Barré syndrome (GBS) continued vaccination with Janssen and AstraZeneca COVID-19 vaccines. Both vaccines use an adenovirus platform as a backbone.

GBS is a rare immune system disorder that causes muscle weakness, pain or numbness, and in more severe cases, paralysis. GBS can have different causes, including infections, and occurs more frequently in men and people over 50. Cases can occur coincidentally after vaccination. For example, rare cases of GBS have been seen after seasonal flu shots and vaccines to protect against shingles, but it is not known whether the vaccines cause GBS (1, 2). A systematic review and meta-analysis in 2011 estimated the background incidence of GBS at 0.8-1.9 / 100,000 in Europe and North America (3)

For Vaxzevria (the AstraZeneca COVID-19 vaccine made in Europe), the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) issued a statement on July 9 recommending the addition of a warning to raise awareness of GBS after vaccination, although they could not confirm or rule out an association with the vaccine (4). A total of 227 cases of GBS had been reported by the EU / EEA to the EMA with Vaxzevria as of June 27, 2021, while around 51.4 million doses of Vaxzevria had been administered to people in the EU / EEA as of June 20, 2021 (5).

For Johnson & Johnson’s (Janssen) COVID-19 vaccine, the US FDA on July 13 announced a revision of vaccine recipient and vaccinator information sheets to include information related to increased risk observed GBS after vaccination (6). The U.S. Advisory Committee on Immunization Practices (ACIP) reviewed the information at its July 22 meeting and noted that as of June 30, 100 cases of GBS had been reported in the Vaccine Adverse Events Reporting System, the passive surveillance nationwide in the United States, with approximately 12.2 million doses of the Janssen vaccine.

Likewise, on July 22, the EMA issued a statement that GBS will be listed as a very rare side effect of the COVID-19 Janssen vaccine and that a warning will be included in the product information in order to educate professionals. health and people receiving the vaccine (7).

The GACVS subcommittee reviewed the statements and measures put in place by the US FDA and EMA. The subcommittee also reviewed preliminary data from Vigibase, the WHO’s global database of individual case safety reports (ICSR), which indicated 164 unconfirmed cases of GBS in countries outside of the country. ‘EEA and United States for Astrazeneca vaccines (Vaxzevria and Covishield), of which 14 of the unconfirmed GBS cases were reported (within 14 days) after 19.5 million doses of (different brands of) Astrazeneca vaccines in from countries in Central and South America.

Based on a careful scientific review of the available information, the GACVS Sub-Committee reached the following conclusions and recommendations:

Rare cases of GBS have been reported following vaccinations with COVID-19 adenoviral vector vaccines.

An increase in GBS reports has not been observed after COVID-19 mRNA vaccines.

More rigorous studies using alternative data sources and robust study designs, and a comparison of vaccinated and unvaccinated populations would be needed to fully assess the significance of these events. The GACVS subcommittee will continue to monitor SGB and any other safety issues and examine further as more data becomes available.

Healthcare professionals should monitor and report all adverse events, including GBS. Countries should continue to collect detailed data on cases. Ideally, data should be collected through active surveillance within hospitals to allow a deeper understanding of this safety issue. The WHO COVID-19 Vaccine Safety Surveillance Manual provides guidance to countries on safety surveillance and sharing of adverse event data for COVID-19 vaccines (8).

People receiving Janssen or AstraZeneca COVID-19 vaccines should be alert for signs and symptoms of GBS and should seek immediate medical attention if they develop weakness / tingling and paralysis in the extremities which may progress to other parts of the body. , including chest and face. Symptoms may include difficulty walking; difficulty with facial movements; double vision or inability to move the eyes; or difficulty controlling the functions of the bladder or bowels. Healthcare professionals should be aware of these signs and symptoms to allow early diagnosis and treatment. Most people fully recover from GBS.

While countries should always consider their individual pandemic circumstances and benefit-risk profiles, overall, the subcommittee concludes that the potential benefits of the Janssen and AstraZeneca COVID-19 vaccines continue to outweigh everything. potential risk of GBS, especially given the increase in the most transmissible cases. Delta variant (B.1.617.2).

The GACVS COVID-19 subcommittee will continue to review safety data for all COVID-19 vaccines and update all guidance as necessary. Open, transparent and evidence-based communication about the potential benefits and risks to beneficiaries and the community is essential to maintain trust. WHO is closely monitoring the deployment of all COVID-19 vaccines and will continue to work closely with countries to manage potential risks and use science and data to guide responses and recommendations.

The references:

(1) Haber P, Sejvar J, Mikaeloff Y, DeStefano F. Vaccines and Guillain-Barré syndrome. Drug Saf. 2009; 32 (4): 309-23. doi: 10.2165 / 00002018-200932040-00005. PMID: 19388722.

(2) Miller ER, McNeil MM, Moro PL, Duffy J, Su JR. The Vaccine Adverse Event Reporting System (VAERS) reporting sensitivity for anaphylaxis and for Guillain-Barré syndrome. Vaccine. 2020; 38 (47): 7458-7463. doi: 10.1016 / j.vaccine.2020.09.072. Published online 7 Oct 2020 PMID: 33039207.