UK on track to meet vaccine target despite pause in Janssen rollout in Europe
Regulators in the UK said that they will examine ‘any safety reports’ during their considerations on whether or not to approve the jab.
Britain is still on track to offer a Covid-19 vaccine to all UK adults by the end of July – despite a pause in the rollout of the Janssen vaccine in Europe, officials have confirmed.
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).
The doses are expected to arrive in the second half of 2021 if approved by the regulator.
But the Department of Health and Social Care (DHSC) insisted Johnson & Johnson’s decision to delay the rollout of its vaccine in Europe would not derail the UK’s programme to offer a jab to all adults by the end of July.
Johnson & Johnson confirmed it will delay rollout of its single-dose vaccine across Europe after the US paused the administration of the jab to investigate six cases of potentially dangerous blood clots seen in 6.8 million people vaccinated.
Regulators in the UK said that they will examine “any safety reports” during their considerations on whether or not to approve the jab.
A DHSC spokesperson said: “Our vaccination programme continues to make phenomenal progress – with over 40 million vaccines administered so far.
“We have hit our target to offer a vaccine to everyone in phase one of the vaccination programme and we are on track to offer a jab to all adults by the end of July.”
The MHRA’s director of licensing Dr Siu Ping Lam added: “No vaccine would be authorised for use in the UK unless the expected high standards of safety, quality and effectiveness have been met.
“Vaccine safety is of paramount importance and we will monitor and evaluate any safety reports received promptly and robustly before a decision is made, working and sharing safety data with international regulators as necessary.”
Professor Anthony Harnden, deputy chairman of the Joint Committee on Vaccination and Immunisation (JCVI), told BBC Radio 4’s World At One: “The Johnson & Johnson vaccine of course is the same platform vaccine as the AstraZeneca, it’s an adenoviral vector platform vaccine, so I think this news is important and I think clearly they are experiencing (blood clot) cases in the United States and have paused that vaccine programme.
“We need to look at this data very carefully.”
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.”
In a joint statement, the US Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) said they were investigating clots in six women aged 18-48 that occurred six to 13 days after vaccination.
The clots occurred in veins that drain blood from the brain and occurred together with low platelets.
More than 6.8 million doses of the J&J vaccine have been administered in the US, the vast majority with no or mild side effects.
Downing Street said it would not “prejudge” the MHRA’s decision on the safety of the jab.
The Prime Minister’s spokesman said: “On Johnson & Johnson, it’s for the MHRA to make a ruling – obviously they are independent so I’m not going to prejudge their decision.
“It’s right that the independent safety watchdog looks at this and gives a ruling.”
Dr Peter English, a past chairman of the British Medical Association’s public health medicine committee, said: “This would appear to be a highly precautionary move by the US agencies.
“According to reports to date, there appear to have been six cases of central venous sinus thrombosis (CVST), in over 6.8 million doses of vaccine given.
“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.”
Ian Douglas, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said: “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.”
“It’s vital to stress all indications are that this is incredibly rare, in this instance around a one 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.”
