Pfizer and Moderna DENIED to join Johnson & Johnson study on the risks of blood clots in vaccines

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J & J's vaccine has been suspended in the United States after nine people - two in clinical trials and seven after vaccine approval - developed rare but serious blood clots in more than 7 million vaccinations.



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Johnson & Johnson has privately contacted competing COVID-19 vaccine makers to join an effort to study the risks of blood clots.

According to the Wall Street Journal, citing three people familiar with the subject, J&J wanted to form an informal alliance with other companies to communicate with one voice about the benefits and risks of vaccines as well as blood clots.

Only AstraZeneca Plc – which has been at the center of a similar blood clotting controversy for several weeks in Europe – agreed.

However, executives at Pfizer Inc and Moderna Inc reportedly refused, saying their vaccines appeared safe.

It comes as a J&J vaccine hiatus continues in the United States after several people developed rare, but serious blood clots within days of receiving the vaccine.

Johnson & Johnson has privately asked other vaccine makers to join a study on the risks of blood clots, the Wall Street Journal reported (file image)

J & J's vaccine has been suspended in the United States after nine people - two in clinical trials and seven after vaccine approval - developed rare but serious blood clots in more than 7 million vaccinations.

J & J’s vaccine has been suspended in the United States after nine people – two in clinical trials and seven after vaccine approval – developed rare but serious blood clots in more than 7 million vaccinations.

J & J’S VACCINE AND BLOOD BUTTONS: WHAT YOU NEED TO KNOW

The CDC and the FDA recommended that the rollout of the J&J vaccine be halted on Tuesday after several reports of rare but serious blood clots.

Nine people aged 18 to 59 developed cerebral venous sinus thrombosis (CVST).

CVST is a rare type of blood clot that blocks the sinus channels in the brain to drain blood, which can cause bleeding.

One of the nine patients has died and two are in critical condition.

With over seven million people who have received the vaccine, that means only 0.00012% have developed CVST.

This is less than the five in a million people – 0.0005% – who develop the disease in the general population.

The CDC and the FDA say these events appear to occur a week to “no more than three weeks” after vaccination.

While there are theories that the J&J vaccine can cause a rare autoimmune reaction, there is currently no evidence to suggest that the injection is related to blood clots.

In addition, although eight of the nine cases were reported in women, there is not enough information to suggest that a particular subgroup is more vulnerable.

On Tuesday, the CDC and the FDA recommended that J & J’s vaccine rollout be suspended after six women under the age of 50 developed blood clots within six to 13 days of being vaccinated.

This report was then updated to include nine people, including two during clinical trials and seven after the vaccine was approved for emergency use.

One person has died and two people are in the hospital in critical condition.

Last week, European regulators said they were examining rare blood clots in four recipients of the J&J vaccine, before U.S. health agencies warned of cases occurring in America.

This led the company, based in New Brunswick, New Jersey, to become closer to other vaccine manufacturers, according to The Journal.

J&J reportedly asked if other companies were seeing clots in vaccinees and if there was any point in looking at the risk.

Officials also suggested forming an expert panel among the four companies to review all reports of blood clots, which AstraZeneca eagerly accepted.

Pfizer and Moderna objected not only because no blood clots had been seen with their vaccines, but also because they saw no need to duplicate the efforts of agencies already looking for cases of blood clots and testing. the cause.

Additionally, companies feared that if they joined in the effort their reputation could be tainted by the association, officials told the Journal.

In fact, on the day the CDC and FDA recommended a recess, Pfizer and Moderna released a statement saying they had not seen reports of CVST or other blood clotting events in their patients.

An FDA official later released a similar statement.

J&J, AstraZeneca, Pfizer and Moderna were not immediately available for comment on the report.

The vaccine has been hailed as a game changer in the fight against the coronavirus because it is a single dose and it does not need to be stored at freezing temperatures unlike the Pfizer-BioNTech and Moderna vaccines. .

So it came as a shock when a report revealed that six women who had received the J&J COVID-19 vaccine had developed cerebral venous sinus thrombosis (CVST) blood clots.

CVST is a rare type of blood clot that blocks the sinus channels in the brain to drain blood, which can cause bleeding.

It occurs in about five per million people in the general population.

In all six cases, CVST occurred in association with low levels of blood platelets, also known as thrombocytopenia.

This figure of six was later updated to include nine people, but it is not clear whether the other three experienced thrombocytopenia.

It echoes concerns expressed about the AstraZeneca-University of Oxford coronavirus vaccine, after the European medicines regulator said there was a possible link between jab and rare blood clots.

There is currently no evidence that J & J’s vaccine is linked to blood clots or that particular subgroups are at increased risk.

Although the big pharmaceutical companies are generally fierce competitors, the pandemic has led many people to band together

In February, French pharmaceutical company Sanofi signed an agreement with Pfizer and its German partner BioNTech SE to help it manufacture its COVID-19 vaccine.

Sanofi is currently developing its own vaccine with British pharmaceutical company GlaxoSmithKline, but production is delayed after initial clinical trial data turned out to be disappointing.

In the absence of a vaccine ready to produce, Sanofi decided to help BioNTech and Pfizer to increase its manufacturing capacity.

“We asked ourselves how we could make ourselves useful in the present, how to participate in the collective effort to get out of this crisis as quickly as possible”, Sanofi CEO Paul Hudson told Figaro, according to a translation from DailyMail .com.

“We will be using our factor in Frankfurt, Germany, to package the product that will be supplied to us by Pfizer-BioNTech.

In addition, Merck & Co announced that two of its facilities will help J&J produce its single dose vaccines.

One of Merck’s facilities was to help with the filling and finishing part, or to fill the vials with the vaccine itself, while the other was to produce the vaccine itself.

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