The U.S. Food and Drug Administration on Monday added a warning to the fact sheet for Johnson & Johnson’s COVID-19 vaccine saying that data suggests there is an increased risk of a rare neurological disorder in the six weeks after inoculation.
In a letter to the company, the FDA classified the chances of getting Guillain-Barré syndrome (GBS) after vaccination as being “very low.” Still, it said J&J vaccine recipients should seek medical attention if they have symptoms including weakness or tingling sensations, difficulty walking or difficulty with facial movements.
Around 12.8 million people have received J&J’s one-dose vaccine in the United States. The FDA said 100 preliminary reports of GBS in the vaccine recipients include 95 serious cases that required hospitalization and one reported death.
J&J said in a statement that it was in discussion with regulators about the cases of GBS. It said the rate of reported cases of GBS in J&J vaccine recipients exceeds the background rate only by a small degree.
GBS is a rare neurological condition in which the body’s immune system attacks the protective coating on nerve fibers. Most cases follow a bacterial or viral infection. Most people fully recover from GBS.
The condition has been linked in the past to vaccinations – most notably to a vaccination campaign during a swine flu outbreak in the United States in 1976, and decades later to the vaccine used during the 2009 H1N1 flu pandemic.
According to a statement from the U.S. Centers for Disease Control and Prevention (CDC), most of the cases were in men, many of whom were 50 or older. It did not find higher than expected cases of GBS in recipients of the mRNA-based vaccines from Pfizer Inc/BioNTech SE and Moderna Inc.
Last week, European regulators recommended a similar warning for AstraZeneca’s COVID-19 shot, which is based on a similar technology as Johnson & Johnson’s vaccine.
The warning is another setback for the J&J shot, which was supposed to be an important tool for vaccinating in hard-to-reach areas and among those hesitant to be vaccinated because it requires only one shot and has less stringent storage requirements than the Pfizer or Moderna vaccines.
But use of the vaccine has already been linked to a very rare, potentially life threatening blood clotting condition and slowed by production problems at the main plant where it is being made.
U.S. regulators decided in April that the vaccine’s benefits outweighed the risk from the blood clotting issue.
The warning was first reported by the Washington Post on Monday.
Universities to reopen once students and staff have been vaccinated
The Afghan government announced Saturday that the ministries of public health, higher education and education have agreed that class-based lectures for university and college students will gradually resume over the next two weeks.
The Ministry of Higher Education (MoHE) said that the first step will see all students and teaching staff get COVID-19 vaccines before classes resume.
“Class-based lessons will restart gradually at all institutions registered with the MoHE,” said Hamid Obaidi, spokesman for the MoHE adding that classes will first resume in provinces that have a low coronavirus infection rate.
Meanwhile, the Ministry of Education said that school examinations will start during this solar month.
According to the ministry, a decision has yet to be made on resuming classroom lessons for school students.
“The examination process will take time because we want to hold exams in many shifts to avoid large gatherings,” said Najiba Arian, a spokeswoman for the MoE.
The Ministry of Public Health (MoPH) said that the impact of people having travelled around the country over Eid al-Adha will also determine the COVID-19 situation within the next week.
This comes after the MoPH reported 32 deaths as a result of COVID-19 in the past 24 hours across Afghanistan.
The MoPH said 203 new infections were registered in the mentioned time.
Olympics-Athlete COVID-19 infections rise in Tokyo
Tokyo Olympics organisers on Sunday reported three new cases of COVID-19 infection among athletes, up from one new case a day earlier, as the population of the athlete’s village swells ahead of the start of the pandemic-hit Games next week.
Organisers reported 10 new cases connected to the Olympics including media, contractors and other personnel, down from 15 on Saturday.
An International Olympic Committee member from South Korea tested positive for the coronavirus on landing in Tokyo. Ryu Seung-min, a former Olympic athlete, is vaccinated, reflecting the infection risk even from vaccinated attendees.
Infection rates are climbing among the general population of the capital, topping 1,000 new cases for four consecutive days. Polls show many Japanese oppose holding the Games with the influx of overseas visitors it entails.
First COVID case found at athletes’ village, stoking fears ahead of Olympics
Tokyo Olympics organisers said on Saturday a person has tested positive for COVID-19 at the athletes’ village, the first case at a site where most competitors will be staying, raising new doubts over promises of a “safe and secure” Games.
The organisers confirmed that a visitor from abroad who is involved in organising the Games had tested positive during a routine test on Friday, Reuters reported.
The person’s nationality was not revealed due to privacy concerns.
The Summer Olympics are taking place from 23 July to 8 August 2021.
ANDSF to launch offensives in north to retake fallen districts
Well known Afghan comedian gunned down in Kandahar
Taliban negotiating team member’s son killed in clashes in Afghanistan
Biden, Kadhimi seal agreement to end U.S. combat mission in Iraq
MoI claims Kandahari Journalists propagandize in favor of Taliban
Taliban issues new ‘laws’ in captured districts
US slips out of Bagram silently without notifying new commander
U.S. carries out air strikes against Iran-backed militia in Iraq, Syria
Taliban says it controls 85% territory of Afghanistan
At least 17 killed in Philippines troop plane crash
Morning News Show Part 1: Increase of insecurity in Nangarhar discussed
Sola: Ongoing fierce clashes, peace efforts discussed
Tahawol: Reactions on Rome summit about Afghanistan discussed
Morning News Show: Calls for ceasefire in Afghanistan discussed
Zerbena: Decline in use of Afghan currency in trade discussed
Latest News4 days ago
To reach a peace deal, Taliban say Ghani must go
Latest News4 days ago
Afghan NSA warns of possible influx of Taliban recruits from Pakistan
Olympic Games Tokyo 20204 days ago
Slimmed-down opening ceremony reflects pandemic-hit Tokyo Games
Latest News4 days ago
U.S. launches air strikes to help embattled Afghan forces
World4 days ago
Heavy rains kill 18 in India, dozens feared trapped in landslides
Latest News4 days ago
Time for both sides to stop fighting and make a deal, say foreign stakeholders
Latest News5 days ago
Tajikistan says it’s ready to take in up to 100,000 Afghan refugees
Featured3 days ago
Govt rolls out curfew in 31 provinces to curb Taliban activities