FDA says Johnson & Johnson vaccine pause predicted to ultimate a "rely of days"

 FDA says Johnson & Johnson vaccine pause predicted to ultimate a "rely of days"

As CBS information' Debora Alfarone reviews, federal health officers are advising a temporary stop to administering Johnson & Johnson's coronavirus vaccine after reviews of some unfavorable reactions. CBS news reporter Alex Tin joins CBSN's "pink and Blue" anchor Elaine Quijano to speak about the today's at the vaccine state of affairs.  


Case in man from Johnson & Johnson trials "appears a lot like this," says top CDC professional

A pinnacle CDC reliable stated Tuesday that their probe of the rare mixture of blood clots and coffee platelet counts had turned up a similar case in the course of Johnson & Johnson's medical trials.

"there has been one episode of an occasion that looks plenty like this, it became truely in a man," Dr. Anne Schuchat, essential deputy director of the centers for disorder manage and Prevention, said in an interview with PBS.

Federal health officers initially stated all six instances they were inspecting had befell "among women among the ages of 18 and 48." however, preceding evaluations of those who had received the vaccine synthetic by AstraZeneca - that is based on a comparable platform to Johnson & Johnson's shot - had grew to become up a handful of similar suspected clotting cases in a few guys as properly.

"As you could imagine, if you have an occasion that might be as uncommon as one in one million, that may not show up in a clinical trial, whilst large as the rigors had been earlier than the FDA authorization. and that is why we take very critically monitoring protection," stated Dr. Schuchat.

In its evaluate of Johnson & Johnson's submission for emergency use authorization in February, the food and Drug management had first of all entreated in addition surveillance of a slight "numerical imbalance" in blood clotting events after receiving the shot. on the time, the normal concluded there was "insufficient" facts to determine "a causal dating" with the vaccine.

One of those activities flagged with the aid of the FDA became in a 25-year-antique man with "no past medical records" who skilled several common aspect effects, consisting of a headache, following his shot. even as the trial player recovered from maximum of his side results, the headache persisted and he eventually skilled a "tonic clonic seizure."

The FDA's reviewers stated that occasion led Johnson & Johnson to pause their observe. but in October, the drugmaker announced they could resume the trial pronouncing there was "no proof that the vaccine candidate prompted the event." After an research determined other "possible contributing elements," Johnson & Johnson in the long run concluded that the occasion "was now not associated with the look at product."


U.S. requires pause on Johnson & Johnson vaccine over rare blood clots

Federal health officers have requested states to pause administering the Johnson & Johnson vaccine within the U.S. after six girls evolved a unprecedented blood clot. Jericka Duncan stocks the modern.

Johnson & Johnson pauses doses in medical trials

Johnson & Johnson stated late Tuesday that it's miles suspending vaccinations of their ongoing clinical trials, after earlier saying handiest that they could "proactively delay" the rollout of their shots in Europe.

"we've made the choice to proactively postpone the rollout of our vaccine in Europe and pause vaccinations in all Janssen COVID-19 vaccine clinical trials at the same time as we update steering for investigators and individuals," the business enterprise said an up to date announcement on Tuesday.

The drugmaker has a handful of ongoing clinical trials to check their pictures, which includes a currently increased phase 2 examine trialing the doses in youngsters.

U.S. regulators hinted at the opportunity Johnson & Johnson may suspend the trials, asked about it at a press briefing earlier Tuesday.

"I suppose you can observe statements that will come out of J&J nowadays approximately their voluntary actions in reaction to this request for a pause," Dr. Peter Marks, director of the meals and Drug management's middle for Biologics assessment and research, advised newshounds.