Johnson & Johnson

Johnson & Johnson Covid Vaccine Approved for Use in U.K.

The Johnson & Johnson (J&J) Covid vaccine has been approved for use in the U.K.. Like the vaccine made by AstraZeneca, J&J’s vaccine has been linked to blood clotting, with the Centers for Disease Control and Prevention (CDC) finding earlier this month that there is a “plausible causal association” between the two. Sky News has more on the use of the vaccine in the U.K..

The vaccine, developed by the company’s pharmaceutical arm Janssen, has been shown to be 67% effective overall at preventing moderate to severe Covid, with some studies suggesting it also offers complete protection from admission to hospital and death.

In a statement, Health Secretary Matt Hancock described the approval as “a further boost to the U.K.’s hugely successful vaccination programme, which has already saved over 13,000 lives”…

The U.K. has ordered 20 million doses of the vaccine, which England’s Deputy Chief Medical Officer, Professor Jonathan Van-Tam, has previously said could be used for hard-to-reach groups of people, where recalling them for a second jab is not always successful [because only one dose is required].

The [Medicines and Healthcare products Regulatory Agency] is thought to have held back from early approval of the vaccine after concerns were raised in the U.S. about a link to extremely rare blood clots.

The clots are similar to those seen in a very small proportion of people having the AstraZeneca jab.

In April, the use of the shot was suspended in the U.S. while the US CDC investigated eight “serious” cases of rare blood clots associated with low blood platelets, among the seven million people who had been vaccinated.

One person died.

The vaccine’s rollout was resumed after a week – after concerns had been assuaged – but the European Medicines Agency recommended a warning about unusual blood clots with low blood platelet count should be added to the product information for the vaccine.

Worth reading in full.

CDC Finds More Clotting Cases After Johnson & Johnson Covid Vaccine

The Centers for Disease Control and Prevention (CDC) has said there is a “plausible causal association” between the Johnson & Johnson (J&J) Covid vaccine and blood clotting after finding more U.S. cases of the condition among people who received the vaccine. Reuters has the story.

The CDC said in a presentation the Agency has now identified 28 cases of thrombosis with thrombocytopenia syndrome (TTS) among the more than 8.7 million people who had received the J&J vaccine. TTS involves blood clots accompanied by a low level of platelets – the cells in the blood that help it to clot.

So far, three of the 28 have died. Previously, as of April 25th, the CDC had reported 17 cases of clotting among nearly eight million people given vaccines.

The Advisory Committee on Immunisation Practices (ACIP), which advises the U.S. CDC, recommended on April 23rd that the U.S. lift a 10-day pause on the J&J vaccinations imposed to review safety data on the clotting issue. The panel will review the new data later on Wednesday…

Scientists are working to find the potential mechanism that would explain the blood clots. A leading hypothesis appears to be that the vaccines are triggering a rare immune response that could be related to these viral vectors.

The syndrome does not appear to be associated with either of the Covid vaccines produced by Pfizer or Moderna.

Most of the cases were among women aged 18 to 49, the CDC said, with rates among women aged 30-39 at 12.4 cases per million and those aged 40-49 at 9.4 cases per million…

Symptoms typically occur several days after vaccination to up to two weeks.

Norway, which has stopped using the AstraZeneca Covid vaccine because of fears over blood clotting, has delayed a decision on whether to include vaccines made by J&J in its national rollout efforts. A Government-appointed commission recently recommended that neither vaccine should be used in the country due to their harmful side effects.

The Reuters report is worth reading in full.

12 Year-Olds to Be Given Covid Vaccines from September

Children as young as 12 will be given Covid vaccines when they return to school after summer, according to leaked “core planning” documents. Even younger children could be vaccinated shortly afterwards, with Oxford University’s ongoing child vaccine study testing the AstraZeneca jab on 300 children aged six to 17. The Government reportedly wants to vaccinate the young to help the nation avoid a third wave of Covid infections. MailOnline has the story.

Children as young as 12 will get their coronavirus vaccines from September as the Government tries to avoid a third wave, reports say…

There are also reportedly plans for Britons over 50 to be given booster jabs in the autumn amid fears over Covid variants sweeping Europe…

A source told the Sun: “Plans are in place to vaccinate children aged 12 upwards, and senior Government officials have been briefed.

“Though controversial, it is deemed necessary to stop the U.K. regressing in its remarkable fight against Covid.”

Health officials are also said to be looking into jabbing children as young as five from July in a “worst-case scenario”.

The leaked report shows the Government’s contingency plan if the roadmap out of lockdown this summer leads to a surge in variants…

The Department of Health said no decision has been taken, adding: “We will be guided by experts once clinical trials have concluded.”

This comes in spite of the low risk presented by Covid to young people (as few as 14 people under the age of 20 in England and Wales have died of Covid in 2021) and the fact that a large proportion of those who are vulnerable – whom the Government fears young people could infect – have been vaccinated. (More than 11 million people have now received two doses of a Covid vaccine and 95% of over-50s have been vaccinated.)

Last month, Sean O’Grady, the Associate Editor of the Independent, said that the vaccination of the young should be mandatory.

I would vaccinate every child old enough to receive it, as a condition of receiving a state education. …

Of course, in the end, we do not want to live in a country where gangs of officials grab unvaccinated children or adults, wrestle them to the ground and forcibly inject them. But we do want to live in a country where rights are balanced by responsibilities, and where mutual obligations need to be fulfilled. 

Incentives and penalties, taxes and fines, court orders and conditions of employment – restrictions on liberty – are commonplace in our daily lives; for the protection of the community as a whole. If we want to drive the wrong way down a motorway, then there are legal consequences for doing so.

Meanwhile, the reported risk of suffering from blood clots after taking the AstraZeneca vaccine (Britain’s primary Covid vaccine) has doubled in a fortnight, according to new data from the Medical Healthcare products and Regulatory Agency. The European Medicines Agency has also said that a warning about blood clots should be added to labels for the Johnson & Johnson Covid vaccine, which is likely to be approved for use in the U.K. in the coming weeks. Dr Alan Mordue, a retired public health consultant, recently wrote for Lockdown Sceptics that “the potential benefits [of vaccination] may not be justified by the potential risks” for people under the age of 50.

The Mail’s report is worth reading in full.

Warning About Blood Clots Should be Added to Labels for Johnson & Johnson’s Covid Vaccine, Says E.U.’s Medicines Regulator

There is a “possible link” between the Johnson & Johnson (J&J) Covid vaccine and blood clots, according to the European Medicines Agency (EMA). The regulator says that a warning should be added to labels for the vaccine. Sky News has the story.

The EMA says it has found a possible link between the J&J Covid vaccine and very rare cases of unusual blood clots.

European regulators say that unusual blood clots with low blood platelets should now be listed as “very rare” side effects of the vaccine.

But they stressed that the “overall benefits of the vaccine in preventing Covid outweigh the risks of side effects”.

The new warning is based on eight “serious” cases in the U.S., one of which resulted in the person dying.

All eight people were under the age of 60 and developed clots within three weeks of vaccination, the EMA said, with the majority of cases being women.

They were “very similar to the cases that occurred with the Covid vaccine developed by AstraZeneca”, it added.

The Guardian has more on the next steps for the J&J vaccine.

The EMA has said a warning about very unusual blood clots should be added to labels for J&J’s Covid vaccine…

J&J advised European governments to store their doses until the E.U. drug regulator issued guidance on their use; widespread use of the shot in Europe has not yet started.

The delay is a further blow to vaccination efforts in the European Union, which have been plagued by supply shortages, logistical problems, and concerns over blood clots from those who have received the AstraZeneca vaccine.

The Sky News report is worth reading in full.

EU Commission to End AstraZeneca and Johnson & Johnson Vaccine Contracts at Expiry

The EU Commission will not renew Covid vaccine contracts with AstraZeneca and Johnson & Johnson (J&J) when they expire, according to reports. The vaccines produced by both of these companies are facing scrutiny over their links to blood clotting and have been subject to numerous medical reviews. Reuters has the story.

The EU Commission has decided not to renew Covid vaccine contracts next year with AstraZeneca and J&J, Italian daily La Stampa reported on Wednesday, citing a source from the Italian health ministry.

“The European Commission, in agreement with the leaders of many (EU) countries, has decided that the contracts with the companies that produce (viral vector) vaccines that are valid for the current year will not be renewed at their expiry,” the newspaper reported. …

A spokesman for the EU Commission said it was keeping all options open to be prepared for the next stages of the pandemic, for 2022 and beyond.

“We cannot, however, comment on contractual issues,” the spokesman added.

Later on Wednesday the President of the European Commission said the EU was in talks with Pfizer and BionTech for a new contract for 1.8 billion doses, confirming a Reuters report from last week.

“We need to focus on technologies that have proven their worth. mRNA vaccines are a clear case in point,” she added.

La Stampa reports that Brussels would rather prioritise Covid vaccines from Pfizer and Moderna – both of which use mRNA technology – in the UE’s rollout efforts. Studies from across Europe have shown that many people are refusing the AZ vaccine due to concerns over its link to blood clots (for example, 33% of Danes and up to 80% of Sicilians would reportedly turn the vaccine down). The rollout of J&J Covid vaccines in Europe has also recently been delayed by the company, following reports on its relationship with rare blood clots.

The Reuters report is worth reading in full.

Stop Press: The Danish Health Authority has announced that it will no longer be recommending the AstraZeneca vaccine.

There is a possible link between very rare cases of unusual blood clots, bleeding, low blood platelets counts and the vaccine from AstraZeneca. This, coupled with the fact that the Covid epidemic in Denmark is currently under control and other vaccines are available against Covid, has been instrumental in the Danish Health Authority’s decision to continue its vaccination programme against Covid without the vaccine from AstraZeneca.

Worth reading in full.

US Calls For Pause on Johnson & Johnson Vaccine Due to Clotting Fears

Federal health agencies in America have called for the rollout of the Johnson & Johnson (J&J) vaccine to be paused immediately due to some recipients developing rare blood clotting disorders within two weeks of being vaccinated. So far, nearly seven million people in the US have received shots of the J&J vaccine, which is not currently used in the UK. Six US recipients of the vaccine have developed disorders involving blood clots, all of them women aged 18-48. The New York Times has the story.

Federal health agencies on Tuesday called for an immediate pause in use of J&J’s single-dose coronavirus vaccine after six recipients in the US developed a rare disorder involving blood clots within about two weeks of vaccination.

All six recipients were women between the ages of 18 and 48. One woman died and a second woman in Nebraska has been hospitalised in critical condition. …

“We are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr Peter Marks, Director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, and Dr Anne Schuchat, Principal Deputy Director of the CDC, said in a joint statement. “Right now, these adverse events appear to be extremely rare.”

While the move was framed as a recommendation to health practitioners in the states, the Federal Government is expected to pause administration of the vaccine at all federally-run vaccination sites. Federal officials expect that state health officials will take that as a strong signal to do the same.

Scientists with the FDA and CDC will jointly examine possible links between the vaccine and the disorder and determine whether the FDA should continue to authorise use of the vaccine for all adults or limit the authorisation. An emergency meeting of the CDC’s outside advisory committee has been scheduled for Wednesday.

While the majority of the US’s vaccine supply comes from other sources, it is expected that this pause could “substantially complicate” the nation’s vaccination efforts. The move comes after Europe’s medicines regulator announced last week that it was reviewing possible links between the vaccine and rare blood clots. The jab is expected to be approved for use in the UK “within days“, with 30 million doses having already been ordered by the Government.

J&J said the following in a news release:

We are aware that thromboembolic events including those with thrombocytopenia have been reported with Covid vaccines. At present, no clear causal relationship has been established between these rare events and the J&J Covid vaccine.

The New York Times’s article is worth reading in full.

Stop Press: The European rollout of the vaccine has now been paused, according to a statement released by Johnson & Johnson. The company said: “We have been reviewing these cases with European health authorities. We have made the decision to proactively delay the rollout of our vaccine in Europe.”

Johnson & Johnson Covid Vaccine Under EU Review Over Blood Clots

In recent months, the term “blood clots” has become associated with the AstraZeneca Covid vaccine, but Europe’s medicines regulator is now reviewing possible links between this rare condition and the Johnson & Johnson (J&J) jab. Sky News has the story.

Europe’s drugs regulator is reviewing possible links between blood clots and J&J’s coronavirus vaccine.

The move comes after four serious cases of rare clots with low platelets were reported after the Covid jab, one of which was fatal, according to the European Medicines Agency (EMA).

The J&J (also known as Janssen) vaccine, which has proved 67% effective in preventing infection and completely effective at preventing hospital admissions and death from Covid during trials, is currently only used in the US, under an emergency use authorisation.

The jab was authorised in the EU last month but has not started to be rolled out to members states yet, although this is expected in the next few weeks.

The vaccine stands out from the others being used because only one shot is needed, rather than two.

30 million doses have been ordered by the UK Government, but it has yet to be approved for use by the country’s regulator. Nearly five million people have received the vaccine in the US. Responding to reports of its jab being investigated by the EMA, J&J said it was working with regulators to assess the relevant information.

At present, no clear causal relationship has been established between these rare events and the Janssen Covid vaccine.

Worth reading in full.