© Reuters. FILE PHOTO: Vial and medical syringe appear before the J&J logo in this image
By Manas Mishra and Michael Erman
(Reuters) – U.S. federal health officials on Tuesday recommended halting use of Johnson & Johnson’s (NYSE 🙂 COVID-19 vaccine after six women under the age of 50 who received it developed rare blood clots, which The pandemic caused a new setback in efforts to combat it.
Following the news, Johnson & Johnson (J&J) said it was delaying its vaccine rollout in Europe a week after regulators there announced they would check rare blood clots in four recipients of the shot in the US.
The steps come after European regulators said earlier this month they found a possible link between AstraZeneca’s (NASDAQ 🙂 COVID-19 vaccine and a similar rare blood clotting problem that has resulted in a low number of deaths.
J & J’s single-dose vaccine – most COVID-19 vaccines are given in two doses – and AstraZeneca’s inexpensive vaccine are considered important tools in the fight against a pandemic that killed more than three million people.
The White House said the hiatus had no “significant” impact on its plan to deliver about three million shots a day for a total of 200 million shots before President Joe Biden’s 100th day in office.
Most of the J&J vaccine available has been used in the US due to manufacturing issues that have limited the company’s supply. As of April 12, more than 6.8 million doses of the J&J vaccine had been administered in the United States, compared with more than 180 million shots combined Modern (NASDAQ 🙂 and Pfizer / BioNTech recordings.
An advisory committee from the U.S. Centers for Disease Control and Prevention (CDC) will meet on Wednesday to review the cases and the U.S. Food and Drug Administration (FDA) will review the analysis, the agencies said a joint declaration with.
All six cases were in women between the ages of 18 and 48, and symptoms appeared six to 13 days after vaccination.
In those cases, a type of blood clot known as cerebral venous sinus thrombosis (CVST) has been seen in combination with low blood platelet levels (thrombocytopenia).
The CDC and FDA said the adverse events appeared to be extremely rare.
J&J said it was working closely with regulators and noted that no clear causal link had been established between the cases and the COVID-19 vaccine manufactured by its Janssen unit.
“I think this is a very low risk problem, even if it is causally related to the vaccine: 6 cases with about 7 million doses (less than the risk of blood clots with oral contraceptives) are not cause for panic,” said Dr. Amesh Adalja. An infectious disease expert at the Johns Hopkins Center for Health Security in Baltimore said in an email.
“People are asking me to cancel their J&J vaccine appointments and I’ve told them not to, but I know a lot of wills and this will hinder progress in fighting the pandemic.”
One woman died and a second in Nebraska was hospitalized in critical condition, the New York Times reported, citing officials. (https://nyti.ms/3g70oLK)
“Even if all cases were caused by the vaccine, the risk of less than one in a million would have to be weighed against the benefits of protecting against COVID-19 disease; a disease that in itself causes clotting in many cases,” said Peter English, a retired communicable disease control advisor and vaccine expert.
“Abundance of Caution”
“The FDA’s recommendation to suspend administration of the Johnson and Johnson vaccine out of caution makes sense given the nature of the unusual and serious side effects that the other vaccines do not experience,” said Dr. Robert Klugman of UMass Memorial Medical Center in Massachusetts in an email.
“Although the incidence is very low, the severity and potential for brain damage and other blood clot injuries are of great concern.”
J & J’s shares fell 2.6% in early New York trading.
The J&J and AstraZeneca vaccines both use an adenovirus vector – a harmless cold virus that instructs human cells to produce a protein on the surface of the coronavirus, thereby stimulating the immune system to create an arsenal against the virus that causes COVID-19 to manufacture.
Among the world’s leading developers of COVID-19 vaccines, the Chinese company CanSino Biological and the Russian Gamaleya Institute are also using this approach with the Sputnik V vaccine. Pfizer / BioNtech and Moderna vaccines use mRNA technology.
J & J’s vaccine adoption was slowed by problems in manufacturing facilities.
The company has shipped at least 20 million cans to the United States but is behind schedule on deliveries. Problems at a Baltimore, Maryland facility operated by an outside contractor, Emergent BioSolutions, forced companies to ditch a batch of vaccine.
The facility, which is believed to be one of J & J’s primary manufacturing facilities in the U.S., has yet to be cleared by U.S. regulators for the supply of vaccine doses, and J & J’s shipments to the states were expected to begin next week will decrease sharply.
J&J just started shipping its COVID-19 vaccine to countries in the European Union this week. It is committed to delivering 55 million cans to the block by the end of June and an additional 120 million in the third quarter.
J&J ran vaccinations in South Africa to study the effects on health workers and vaccinated nearly 300,000 people there on Monday, according to the country’s health ministry. J&J recently signed a contract with the African Union for up to 400 million cans.
The European Medicines Agency continues to recommend using AstraZeneca’s COVID-19 vaccine as the benefits outweigh the risks. However, some EU countries have restricted their use to certain age groups.
Australia currently has no plans to include J & J’s coronavirus vaccine in its vaccination campaign, authorities said Tuesday, as it is no longer sourcing vaccines that are being tested for possible links to blood clots.