(Reuters) – U.S. federal health agencies on Tuesday recommended pausing the use of Johnson & Johnson’s COVID-19 vaccine after six recipients developed a rare disorder involving blood clots, in a fresh setback to global efforts to tackle the pandemic.
Following are initial reactions:
Eleanor Riley, professor of immunology and infectious disease at the University of Edinburgh:.
“Whilst a causal link between COVID-19 vaccination, platelet abnormalities and blood clots has not, so far, been confirmed, the index of suspicion is rising that these rare cases may be triggered by the adenovirus component of the AstraZeneca and J&J vaccines.
“Whilst more data need to be collected, and the implications carefully considered, it remains the case that for the vast majority of people the risks associated with contracting COVID-19 far, far outweigh any risk of being vaccinated.
“Moreover, increasing awareness of the possibility of such side-effects means that they should be diagnosed more quickly and treated more successfully.”
Dr. Amesh Adalja, infectious disease expert at the Johns Hopkins Center for Health Security in Baltimore.
“It’s important to remember the ‘hold’ is only on federal vaccine sites — not all.
“I think this is a very low risk issue, even if causally linked to the vaccine: 6 cases with about 7 million doses (lower than the risk of clots with oral contraceptives) is not something to panic about, but the federal government has been overly cautious with many aspects of this pandemic.
“People are asking me if they should cancel their J&J vaccine appointments and I have told them not to. But I know many well and this will stall progress in controlling the pandemic.”
Dr. William Schaffner, infectious disease doctor at Vanderbilt University Medical Center in Nashville.
“It shows our vaccine safety surveillance system is really working.
“We’ll see what the further investigation by the FDA scientists and their external advisory committee show, but it is disturbing, of course,” added Schaffner, who is a consultant to the Advisory Committee on Immunization Practices, which advises the Centers for Disease Control and Prevention.
“It certainly is concerning because the other vaccine in which this issue has been raised is also the other adenoviral vector vaccine, so you have to worry about that. That I think contributed to the very quick action of the CDC that is going to put the use of this vaccine on pause.”
Dr. Robert Klugman at the UMass Memorial Medical Center in Massachusetts.
“The FDA recommendation to pause the administration of the Johnson and Johnson vaccine out of an abundance of caution makes sense in terms of the nature of the unusual and serious side-effect…
“While the incidence is very low, the severity and potential for brain damage and other blood clot-related injuries is of great concern.”
Peter English, retired consultant in communicable disease control and an expert on vaccines:
This “would appear to be a highly precautionary move by the US’ agencies…
“Even if all of the cases were caused by the vaccine, the risk of less than one in a million would have to be set against the benefits of protection from COVID-19 disease; a disease which, in itself, causes clotting in many cases.
“The call for a pause may dent confidence in vaccination. We must hope that, if it does, this will be temporary; and that the rapid action and openness will inspire confidence that vaccine safety is taken extremely seriously.”
Ian Douglas, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine:
“From the limited information available right now, these 6 cases with the J&J vaccine appear to be similar to those seen with the AZ vaccine.
“Given the heightened awareness of this issue with COVID vaccines, it’s not surprising that we see more cases being reported as this snowball effect is a well-known feature of safety reporting with any medicine.
“Whilst it’s too early to conclude whether they are causally related to the vaccine, this type of stimulated reporting is likely to help regulators better determine what’s related to the vaccine and what isn’t.
If a causal link is established, it’s also possible the reports will help us establish possible risk factors for experiencing this outcome, and ultimately help find ways to minimise any risk.”
“As we’ve seen, each country makes its own decision about COVID vaccines based on their known risks and benefits, but also other factors such as the availability of other vaccines, circulating virus levels, local vaccine confidence and political pressures.
“It’s vital to stress all indications are that this is incredibly rare, in this instance around a 1 in a million chance based on what we know to date about the J&J vaccine. To put this into perspective, it’s similar to the chance of being struck by lightning in any given year in the UK. On the other hand, the risks from COVID-19 are substantial. If all 6.8 million people who’ve received the J&J vaccine in the US were infected with the virus, several thousand would likely die and many more, including younger adults, would experience serious and long-lasting after effects.”
Reporting by Julie Steenhuysen and Manas Mishra; Editing by Keith Weir and John Stonestreet
