European rollout of Johnson & Johnson vaccination delayed after series of clotting cases

Verity Bowman
·6 min read
Six women, between the ages of 18 and 48, developed a rare blood disorder  - Dado Ruvic /REUTERS
Six women, between the ages of 18 and 48, developed a rare blood disorder - Dado Ruvic /REUTERS

Johnson and Johnson's vaccination rollout in Europe has been delayed following reports of blood clots in the United States.

US federal health agencies recommended pausing the use of the vaccine earlier on Tuesday as numerous women under 50 developed a rare blood disorder.

The UK has 30 million doses of the inoculation on order but it has not yet been signed off for use by the Medicines and Healthcare products Regulatory Agency (MHRA).

Six women in the US, between the ages of 18 and 48, fell ill within two weeks of receiving the single dose vaccination.

One woman has died, while another is in a critical condition in hospital, dealing a fresh setback to efforts to tackle the pandemic.

How the world's leading vaccines compare on efficacy
How the world's leading vaccines compare on efficacy

The blood clot cases are currently being reviewed with European health agencies, according to a statement released by Johnson & Johnson.

"We have been reviewing these cases with European health authorities," it said. "We have made the decision to proactively delay the rollout of our vaccine in Europe."

To date at least 6.8 million people in the US have been inoculated with the vaccine.

US federal agencies halt use

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) announced that it was investigating clots, in combination with reduced platelet counts in a joint statement on Tuesday.

US federal distribution channels, including mass vaccination sites, will pause the use of the vaccine, and states and other providers are expected to follow.

Officials from the FDA and CDC have suggested that the paused J&J vaccination rollout in the US will last a couple of days, as investigators explore a link between the jab and very rare blood clots.

"Well, the timeframe will depend obviously on what we learn in the next few days, however we expect it to be a matter of days, for this pause," said Janet Woodcock, acting FDA Commissioner.

Anne Schuchat, principle deputy director at the CDC, added: "We are committed to an expeditious review of the available information, and to an aggressive outreach to clinicians so that they know how to diagnose and treat [the blood clots]."

She said that in the days ahead the organisations will provide regular updates as more information emerges.

Those experiencing severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after receiving the vaccine should contact their health care provider, the FDA and CDC said.

The CDC's Advisory Committee on Immunisation Practices will meet Wednesday to discuss the cases and the FDA has also launched an investigation of the cases.

Officials say they also want to educate vaccine providers and health professionals about the "unique treatment" required for this type of clot.

US Vaccine stockpile
US Vaccine stockpile

Rare disorder requires specialised treatment

Peter Marks, director of the FDA's centre for biologics evaluation and research, said that the traditional treatment for blood clots is different from the rare disorder potentially linked to vaccines.

"The issue here with these types of blood clots is that if one administers the standard treatments that we as doctors have learned to give for blood clots, one can actually cause tremendous harm, or the outcome can be fatal.

"So one needs to make sure that providers are aware that if they see people who have low blood platelets, or if they see people who have blood clots, they need to inquire about the history of recent vaccination, and then act accordingly," he said.

UK keeping 'close eye' situation

Professor Anthony Harnden, deputy chairman of the Joint Committee on Vaccination and Immunisation (JCVI), which advises ministers, noted the similarities between the Johnson & Johnson and Oxford/AstraZeneca jabs and promised to keep a "very close eye" on developments in the US.

Asked whether the decision in the US could impact UK deployment, Prof Harnden said the country had "millions" of doses of other vaccines.

He added: "What we will do is tailor the advice of vaccines accordingly to the data that we see, so this is emerging but we can't make any decisions about Janssen (Johnson & Johnson) - it hasn't been approved in this country yet - and obviously we will be keeping a very close eye on the American situation."

US vaccination map
US vaccination map

Plagued by misfortune

The Johnson & Johnson vaccine received emergency use authorisation from the FDA in late February with great fanfare, with hopes that its single-dose and relatively simple storage requirements would speed vaccinations across the country.

Yet the shot only makes up a small fraction of the doses administered in the US as Johnson & Johnson has been plagued by production delays and manufacturing errors at the Baltimore plant of a contractor.

Last week the drugmaker took over the facility to scale up production in hopes of meeting its commitment to the US government of providing about 100 million doses by the end of May.

White House offers reassurance

The White House on Tuesday played down the impact of a decision to pause the rollout of Johnson & Johnson's Covid-19 vaccine on the wider US vaccination effort.

"This announcement will not have a significant impact on our vaccination plan: Johnson & Johnson vaccine makes up less than five percent of the recorded shots in arms in the United States to date," said Jeff Zients, President Joe Biden's Covid-19 response coordinator, in a statement.

AstraZeneca comparison

Until now concern about the unusual blood clots has centered on the vaccine from AstraZeneca, which has not yet received authorisation in the US.

Experts have expressed concerns that there are links between blood clots and vaccines using a vector-based platform - which includes the Johnson & Johnson and AsztraZeneca-Oxford jabs.

Peter Marks, director of the FDA's centre for biologics evaluation and research, said he would "hesitate to call it a class effect".

But he added: "It's plainly obvious to us already that what we're seeing with the Janssen vaccines looks very similar to what is being seen with the AstraZeneca vaccine.

"One is the AstraZeneca, is a chimpanzee adenoviral vector vaccine, the Janssen is a human adenoviral vector vaccine. I can't make some broad statement yet, but obviously they are from the same general class of viral vectors."

Event likelihood - AstraZeneca vaccine risk comparison
Event likelihood - AstraZeneca vaccine risk comparison

An adenovirus vector is a harmless cold virus that instructs human cells to produce a protein found on the surface of the coronavirus, thereby spurring the immune system to prepare an arsenal against the Covid-19-causing virus.

Among leading global Covid-19 vaccine developers, China's CanSino Biological and Russia's Gamaleya Institute with its Sputnik V vaccine are also relying on this approach.

The Pfizer/BioNtech and Moderna vaccines use mRNA technology.

Europe's drugs regulator continues to recommend the use of AstraZeneca's vaccine, saying the benefits outweigh the risks. Several EU countries, however, have limited its use to certain age groups.