A rare disease has been listed as a possible side effect of some Covid-19 vaccines.
The World Health Organization (WHO) identified Guillain-Barré Syndrome (GBS) as a possible side effect of the Astra Zeneca and Johnson and Johnson (J$J) vaccines.
Scientists say GBS is a rare immune system disorder that results in muscle weakness, pain or numbness, and, in more severe cases, paralysis.
WHO says the condition could result from different causes, including infections, and occurs more frequently in males and persons over 50 years old.
The UN health body is now asking all Astra Zeneca and Janssen vaccine recipients to immediately report adverse effects after getting the jab.
“Individuals receiving Janssen or AstraZeneca COVID-19 vaccines should be alert to signs and symptoms of GBS and should seek immediate medical attention if they develop weakness, tingling and paralysis in the extremities that may progress to other parts of the body including the chest and face,” read WHO alert.
“Symptoms may include difficulty in walking; difficulty with facial movements, double vision or inability to move eyes, or difficulty controlling bladder or bowel functions. Healthcare professionals should be aware of these signs and symptoms to allow for early diagnosis and treatment,” WHO said.
Most people however fully recover from GBS, the global health body says.
Vaccines, WHO explains, contain an antigen or the weakened or inactive parts of a particular organism that triggers an immune response within the body. Newer vaccines like the mRNA vaccines contain the blueprint for producing antigens rather than the antigen itself.
“This weakened version will not cause the disease in the person receiving the vaccine, but it will prompt their immune system to respond much as it would have on its first reaction to the actual pathogen,” says the WHO.
In a statement dated July 26, 2021, the COVID-19 subcommittee of WHO Global Advisory Committee on Vaccine Safety (GACVS) admitted that some people could develop the condition after getting vaccinated, but refused to associate it directly with the vaccine.
This is the third time vaccines have been linked to GBS has been linked to vaccinations. Vaccines have previously been identified as a possible cause for illness after people received shots to protect them against seasonal flu and shingles or herpes zoster.
“Cases may occur coincidentally following vaccination. For example, rare cases of GBS have been observed following seasonal influenza vaccines and vaccines to protect against shingles, but it is not known if the vaccines cause GBS,” says WHO.
A report published in 2011 estimated GBS incidence at roughly between 1 and 2 in every 100,000 vaccinated people in Europe and North America.
“A systematic review and meta-analysis in 2011 estimated the background incidence for GBS as 0.8-1.9 out of every 100 000 in Europe and Northern America,” read GACVS statement.
WHO noted the European Medical Agency (EMA) recommendation for the additional warning on possible cases of GBS after vaccination with Astra Zeneca’s Vaxveria, which is manufactured in Europe.
“For Vaxzevria (the AstraZeneca COVID-19 vaccine manufactured in Europe), the European Medicines Agency (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC) issued a statement on 9 July recommending the addition of a warning to raise awareness of GBS following vaccination, although they could not confirm nor rule out an association with the vaccine,” WHO said.
The recommendations were based on reports of more than 200 cases of GBS in more than 51 million doses given.
“A total of 227 cases of GBS had been reported from EU/EEA to EMA with Vaxzevria by 27 June 2021, while around 51.4 million doses of Vaxzevria had been given to people in the EU/EEA region by 20 June 2021,” read the WHO statement.
Kenya’s COVID-19 vaccination program initially used the Astra Zeneca vaccine known as Covishield which was being manufactured by the Serum Institute of Pune, India.
Following the Delta variant driven wave that resulted in an unprecedented public health crisis which forced India to suspend COVID-19 vaccine exports, the country has been dependent on donations from Western countries.
As at August 24, 2021, Kenya had received 1,530,100 doses in donations, and vaccinated 2,501,198 people, representing 2.9 percent of the adult population. Out of these, 1,714,858 have received the first dose, with 786,340 getting the second dose.
The UK government has so far donated 817,000 doses of the Astra Zeneca vaccine, with the country receiving 100,000 donations from India, 72,000 doses from South Sudan and 357,800 doses from Denmark respectively. On Monday, the US donated another 880,460 doses of the Moderna vaccine
On April 21, 2021, Kenya announced plans to import 1 million doses of the Johnson and Johnson (J&J) vaccine in addition to an equivalent 1 million doses of the Pfizer vaccine.
The two batches are yet to arrive in the country.
J&J ’s Janssen jab has also come under the radar for GBS risk, with the United States Food and Drug Administration (FDA) announcing a change to vaccine fact sheets to include increased risk for the condition.
This followed the occurrence of 100 GBS cases after 12.2 million doses of the J&J jab were administered.
“The US Advisory Committee on Immunization Practices (ACIP) reviewed the information at its meeting on 22 July and noted that as of 30 June, 100 cases of GBS had been reported in the Vaccine Adverse Events Reporting System, the US nationwide passive surveillance system, with approximately 12.2 million of doses of the Janssen vaccine,” WHO says.
On 22 July, 2021, the EMA said GBS will be listed as “a very rare side effect of COVID-19 Vaccine Janssen”.
“EMA also indicated that a warning will be included in the product information to raise awareness among healthcare professionals and people taking the vaccine,” WHO reported.
The WHO subcommittee is also urging health workers to be on the lookout for all adverse events after vaccination, including GBS.
“Healthcare professionals should monitor for and report all adverse events including GBS. Countries should continue to collate detailed data on cases. Ideally, data should be gathered through active surveillance within hospitals to provide a more thorough understanding of this safety issue.
The WHO COVID-19 vaccine safety surveillance manual provides guidance to countries on the safety monitoring and adverse events data sharing for COVID-19 vaccines,” said WHO.
The UN body reported that 14 out of the 164 cases were reported within 14 days of the vaccine being administered.
“Of these cases, 14 unconfirmed GBS cases were reported within 14 days, following 19.5 million doses of different Astrazeneca vaccine brands from Central and South American countries,” the WHO said.
Having analyzed existing data on GBS and vaccine-associated incidence, the GACVS subcommittee has concluded that the occurrence of GBS was rare among people vaccinated with adenovirus vector vaccines like Astra Zeneca.
The incidence was also rare among those who got mRNA jabs like Moderna and Pfizer.
“Rare cases of GBS have been reported following vaccinations with adenovirus vector COVID-19 vaccines. Increased reports of GBS have not been observed following mRNA COVID-19 vaccines,” the subcommittee document reads.
GACVS is calling for more comprehensive studies to establish whether a definite causative link exists between these COVID-19 vaccines and GBS.
“More rigorous studies using alternative data sources and robust study designs, and comparison of vaccinated and unvaccinated populations would be needed, to fully assess the significance of these (GBS) events. The GACVS subcommittee will continue to monitor GBS and any other safety concerns and review further as more data become available,” read the statement.
