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Johnson & Johnson vaccine will carry warning label in Europe

2021-04-21T08:04:15.832Z

The European drug regulator believes that the benefits of this vaccine against COVID-19 outweigh the risks of rare cases of thrombosis. In the United States, the FDA is expected to announce its decision this Friday. This is what experts and health authorities say about your safety.



The European Medicines Agency (EMA) said Wednesday that a warning should be added to Johnson & Johnson's COVID-19 vaccine indicating a possible link to "very rare and unusual cases" of blood clots. 

But the European entity did not advise against its use and rather considers that

"the general benefits of the vaccine in the prevention of COVID-19 outweigh the risks of its side effects

,

"

according to a statement.

The European agency reviewed the information available on eight cases of thrombosis that occurred in vaccinated people in the United States, one of whom died. 

[Plan your vaccination: this tool helps to know who is eligible and where to schedule an appointment]

Following the announcement, the Johnson & Johnson company announced that it will resume the distribution of the vaccine in the European Union and will include the warning in the product brochures, which only requires one dose, contrary to the other COVID-19 vaccines approved in the United States. , which require two doses. 

Cases of blood clots from the vaccine are rare - as of April 13, more than 7 million people had received the Johnson & Johnson vaccine in the United States - and are very similar to the cases that occurred with the vaccine developed by the pharmaceutical AstraZeneca, explained the European regulator. 

More than 84 million people in the United States are already fully vaccinated against COVID-19

April 20, 202100: 29

On April 13, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) recommended pausing the use of the vaccine as a precaution, after the rare cases of blood clots were detected. .

As of April 20, regulators have not made a decision on whether to resume enforcement. 

[What should I do if I received the Johnson & Johnson vaccine?

Am I at risk?]

Now, the questions a lot of people are asking are: is the Johnson & Johnson vaccine safe?

Should I wear it if they resume their application?

Here's what medical experts have to say on these two issues in particular. 

"A very good vaccine"

Epidemiologist Jaime Sepúlveda, executive director of the Institute for Global Health Sciences at the University of California, San Francisco, believes the Johnson & Johnson vaccine is safe, although he agrees with the decision to stop its use in the United States while any serious risk of side effects is being studied. 

“It is a reasonable measure for excess of precaution.

I would say that it is a very good vaccine and it can continue to be used in other parts of the world where there are no other vaccination options.

The same could be said about the AstraZeneca vaccine, ”Sepúlveda said. 

Why was use of the Johnson & Johnson vaccine stopped?

We explain it

April 13, 202101: 56

The European Medicines Agency says its scientific evaluations "support the safe and effective use of COVID-19 vaccines", and that

the risk of thrombosis from the Johnson & Johnson injection "is very low." 

For his part, Santiago Neme, infectious disease specialist and medical director of the University of Washington Medical Center, told Noticias Telemundo that if the US regulators give the green light to the vaccine, he would give it without a doubt.

“I have complete confidence in the CDC and the FDA.

If the FDA concludes that it is safe to get this vaccine, I would get it, "he explained.

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And that decision will likely be announced this Friday, according to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIH).

Fauci said on CBS's Face The Nation program that one of the possibilities they are considering is to use the vaccine and add a warning about possible side effects, similar to what the European authorities recommended. But thinking about what the possibilities are, one of the possibilities would be to bring them back (to the J&J vaccines),

but do it with some kind of restriction or some kind of warning

.

I think by Friday we will know the answer to that, ”Fauci explained. 

COVID-19: is the J&J vaccine safe despite its effects?

This is the opinion of an expert

April 14, 202 106: 52

“The vaccine is safe, what happens is that perhaps you have to choose a particular type of population that should not receive this type of vaccine, and this is the important thing.

It is what the authorities at this moment are trying to analyze, ”Dr. Javier Pérez Fernández, a pulmonologist specialist in the city of Miami, explained to Noticias Telemundo.

The cases of thrombosis found in people who received the Johnson & Johnson vaccine in the United States occurred in women between the ages of 18 and 48, and symptoms occurred within six days of receiving the dose, the CDC reported. 

[How can COVID-19 vaccines be safe, if they developed so quickly?]

This situation is similar to what happened with the AstraZeneca vaccine in Europe.

Most cases of blood clots occurred in women under the age of 60.

Canada recommended not applying this vaccine to people under 55 years of age and in Germany it will only be administered to people over 60 years of age. 

Johnson & Johnson's vaccine was 63.3% effective in clinical trials, lower than 95% for the Pfizer / BioNTech vaccine and 94.1% for the Moderna injection, the other two vaccines approved in the United States. 

A dose of Johnson & Johnson's vaccine at a Bay Shore, New York hospital.

The application of the vaccine was temporarily suspended in the US on April 13.

Shannon Stapleton / Reuters

But authorities consider the Johnson & Johnson vaccine to be "highly effective in preventing hospitalization and death in people who have become ill."

None of the people who became infected with COVID at least four weeks after receiving the injection were hospitalized.

In addition, for many people it is more convenient since it only requires one dose. 

“All vaccines have pros and cons, in the case of Johnson & Johnson, it is a single dose and for many people it is adequate because it is difficult for them to return for a second vaccine.

In those cases, this is the best, ”said epidemiologist Ricardo Castillo Neyra, from the University of Pennsylvania. 

Source: telemundo

All news articles on 2021-04-21

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