The European Union’s medicines regulator yesterday said it had found a “possible link” between Johnson & Johnson’s (J&J) COVID-19 vaccine and the development of rare blood clots in a small number of recipients, but concluded the shot’s overall benefits outweigh any risks associated with its use.
The European Medicines Agency (EMA) said its safety committee decided that a warning about unusual blood clots with low blood platelets must be added to the vaccine’s labels, just as the regulator has also required of rival vaccine maker AstraZeneca, whose own jab was found by the agency last month to also have a “possible link” with rare blood clots.
The EMA found that all instances of clotting had occurred in adults under 60 years, mostly women, within three weeks of vaccination with J&J’s single-shot vaccine. The agency said these rare blood disorders should be considered as “very rare side effects of the vaccine”.
It said all available evidence, including eight cases that were reported in adults who had received the jab in the United States, including one death, had formed part of its assessment.
The watchdog also said that most clots among recipients had occurred in the brain and abdomen, as was the case with AstraZeneca’s shot, which is also being studied for similar rare clotting problems.
The EMA’s update came after J&J last week halted the European rollout of its one-dose shot in response to a recommendation by the US Food and Drug Administration (FDA) that officials pause its use while the rare blood clot cases were examined.
The cases were reported out of more than seven million doses administered in the US as of April 13, the EMA said.
J&J had advised European governments to store their doses until the EMA issued guidance on their use, and the US-based pharmaceutical giant is reportedly prepared to resume the deployment of its vaccine following the agency’s review.
The company has said it would aim to deliver 55 million doses to the European Union, as contracted, by the end of June. It is one of four COVID-19 vaccines authorised for use in the bloc.
But widespread use of the shot among its 27-member states has not yet started, with the recent delay posing a fresh setback to already faltering vaccination efforts in the union, in particular, and global efforts to tackle the coronavirus pandemic.
The EU’s choppy vaccine rollout has been plagued by problems including poor coordination between national and regional authorities, supply shortages, concerns over the AstraZeneca shot and a damaging contractual row with the Anglo-Swedish company.
With the AstraZeneca vaccine, scientists in Norway and Germany have suggested that some people are experiencing an abnormal immune system response, forming antibodies that attack their own platelets.
It is not yet clear if there might be a similar mechanism with the J&J shot.
But both the J&J and AstraZeneca vaccines, as well as a Russian-made COVID-19 vaccine and one from China, are made with the same technology.
They train the immune system to recognise the spike protein that coats the coronavirus. To do that, they use a cold virus, called an adenovirus, to carry the spike gene into the body.
“Suspicion is rising that these rare cases may be triggered by the adenovirus component of the AstraZeneca and J&J vaccines,” Eleanor Riley, a professor of immunology and infectious diseases at the University of Edinburgh, told the Associated Press news agency.
Riley said that while more data was needed, “it remains the case that for the vast majority of adults in Europe and the US, the risks associated with contracting COVID-19 far, far outweigh any risk of being vaccinated”.
Non-stop Cremations Cast Doubt On India’s Counting Of Dead
Gas and firewood furnaces at a crematorium in the western Indian state of Gujarat have been running so long without a break during the COVID-19 pandemic that metal parts have begun to melt.
“We are working around the clock at 100 percent capacity to cremate bodies on time,” Kamlesh Sailor, the president of the trust that runs the crematorium in the diamond-polishing city of Surat, told the Reuters news agency.
And with hospitals full and oxygen and medicines in short supply in an already creaky health system, several big cities are reporting far larger numbers of cremations and burials under coronavirus protocols than official COVID-19 death tolls, according to crematorium and cemetery workers, media and a review of government data.
India’s daily COVID-19 cases retreated from record levels yesterday but stayed above the 200,000 mark for a sixth-straight day, with cases increasing by 259,170 over the last 24 hours. Deaths rose by a record 1,761, health ministry data showed.
Officially, almost 180,000 Indians have died from coronavirus, 15,000 of them this month, although some believe the real number may be higher.
Indian social media and newspaper reports have been flooded with horrifying images of row upon row of burning pyres and crematoriums unable to cope.
In the western state of Gujarat, many crematoriums in Surat, Rajkot, Jamnagar and Ahmedabad are operating around the clock with three to four times more bodies than normal.
Prashant Kabrawala, a trustee of Narayan Trust, which manages a third city crematorium called Ashwinikumar, declined to provide the number of bodies received under the virus’ protocols but said cremations there had tripled in recent weeks.
“I have been regularly going to the crematorium since 1987, and been involved in its day-to-day functioning since 2005, but I haven’t seen so many dead bodies coming for cremation in all these years,” even during an outbreak of the bubonic plague in 1994 and floods in 2006.
The iron frames inside another in Surat melted because there was no time to let the furnaces cool.
“Until last month we were cremating 20-odd bodies per day… But since the beginning of April we have been handling over 80 bodies every day,” said a local official at the Ramnath Ghela Crematorium in the city.
Last week, Sandesh, a Gujarati newspaper, counted 63 bodies leaving a single COVID-19-only hospital for burial in the state’s largest city, Ahmedabad, on a day where government data showed 20 coronavirus deaths.
The chimney of one electric furnace in Ahmedabad cracked and collapsed after being in constant use for up to 20 hours every day for the past two weeks.
With waiting times of up to eight hours, Rajkot has set up a dedicated 24/7 control room to manage the flow in the city’s four crematoriums.
Government spokesmen in Gujarat did not respond to requests for comment.
In Lucknow, the capital of the populous northern state of Uttar Pradesh, data from the largest coronavirus-only crematorium, Baikunth Dham, shows double the number of bodies arriving on six different days in April than government data on COVID-19 deaths for the entire city.
At two crematoriums in Lucknow, relatives were given numbered tokens and made to wait for up to 12 hours. One started burning bodies in an adjacent park, an official told AFP news agency.
Rohit Singh, whose father died from COVID-19, said crematorium officials were charging around 7,000 rupees ($100) – almost 20 times the normal rate.
Some crematoriums in Lucknow ran out of wood and asked people to bring it themselves. Viral photos on social media showed electric rickshaws laden down with logs.
In Ghaziabad outside New Delhi, television pictures showed bodies wrapped in shrouds lined up on biers on the pavement with weeping relatives waiting for their slot.
The ultimate place for Hindus to be cremated is Varanasi, the ancient city where since time immemorial bodies have been burned on the banks of the river Ganges.
Belbhadra, who works at one of the famous ghats there, told AFP that they were cremating at least 200 suspected coronavirus victims per day.
The usual time to get to the ghat – a riverside embankment for cremations – from the main road via narrow lanes was usually three or four minutes, a resident said.
“Now it takes around 20 minutes. that’s how crowded the lanes are with people waiting to cremate the dead,” he said.
The figures from Lucknow do not take into account a second COVID-19-only crematorium in the city or burials in the Muslim community that makes up a quarter of the city’s population.
Crematorium head Azad, who goes by only one name, said the number of cremations under COVID-19 protocols had risen five-fold in recent weeks.
“We are working day and night,” he said. “The incinerators are running full time but still many people have to wait with the bodies for the last rites.”
A spokesman for the Uttar Pradesh government did not respond to a request for comment.
A summer storm is buffeting New Delhi as Mohammed Shamim wearily pauses to glance at yet another ambulance arriving with a coronavirus victim to bury, just minutes after the last.
The gravedigger’s grim workload, like those of others around India, has grown dramatically in the past few weeks in a brutal second wave that has caught authorities badly off guard.
By sunset, 20 bodies were in the ground. This compares to some days in December and January, when his earthmoving machine stayed idle and when many thought the pandemic was over.
“Now, it looks like the virus has legs,” Shamim, 38, a gravedigger like his father and grandfather, told AFP. “At this rate, I will run out of space in three or four days.”
Around the graveyard, white body bags or coffins made out of cheap wood are carried around by people in blue or yellow protective suits and lowered into graves.
Small groups of men, some in skullcaps, look solemnly at the ground as the imam, struggling to be heard as dust laced with rain swirls around, recites final prayers.
Sobbing women watch from their closed car windows next to the flashing lights of an ambulance as a yellow digger fills up the graves with the dry brown and grey soil.
“Two days ago someone came to me and said he needs to start preparing for his mother because doctors had given up on her,” Shamim said.
“It’s unreal. I never thought I’d see the day where I’d have a request for starting the funeral formalities of a living person.”
Elsewhere, India Today magazine reported two crematoriums in Bhopal, the capital of the central state of Madhya Pradesh, 187 bodies were cremated following COVID-19 protocols in four days this month, while the official coronavirus death toll stood at five.