FDA Calls for Halt to Administration of Johnson & Johnson Vaccine

Citing a disturbing link to at least one death and the hospitalization of a second vaccinated woman for thrombosis, the United States’ Food and Drug Administration on Tuesday called for a halt to federally-sponsored inoculation campaigns using the Johnson & Johnson vaccine.

The FDA and the Centers for Disease Control (CDC) are going to place a pause on the use of the J & J vaccine at all federal inoculation sites and they say that they “urge” states to do the same while they investigate the safety of the vaccine.

As of Tuesday, a total of six individuals in the United States developed a rare disorder involving blood clots within about two weeks of becoming vaccinated with the Johnson & Johnson product, according to officials.

Majority of thrombosis cases involved females

And like the majority of those who experienced problems with the AstraZeneca vaccine, all six recipients who reported issues with the J & J vaccine were women between the ages of 18 and 48. One woman died and another female in Nebraska has now been hospitalized with thrombosis and is in critical condition, the officials told reporters.

All the females developed the thrombosis condition between six and 16 days after being vaccinated. Government experts are concerned that an immune system response triggered by the vaccine caused the problems.

At the present time, almost seven million people in the United States have received Johnson & Johnson shots so far, and approximately nine million more doses have now been shipped out to the states for their various inoculation programs, according to the US CDC.

Johnson & Johnson vaccine halt throws money wrench into inoculation campaigns

All federally operated vaccination sites are expected to follow the recommendations and US  officials believe that health officials from all fifty states will follow suit.

Scientists from the FDA and CDC will be looking for possible links between the vaccine and the clotting disorder experienced by the women in an effort to determine if the FDA should continue authorizing use of the vaccine for all adults. Another alternative is for the inoculation to continue to be given but with limited authorization.

THE CDC’s outside advisory commission, which looks at all vaccine candidates before they are even given to the FDA, will hold an emergency meeting on Wednesday, officials told the press.

An FDA spokeswoman declined to comment when asked for more information by the New York Times.

The pause in administering the J & J vaccine comes at a time when “variants of concern,” the mutations of the coronavirus, made up fully 39% of cases in the United States during the two weeks ending March 13.

The UK variant (known as B.1.1.7) was by far the most prevalent of any strain, comprising 27% of these cases. The South African and Brazilian variants each accounted for less than 1% of current coronavirus cases in the US.

The states of Alaska, New Mexico, and South Dakota currently lead the nation in vaccination rates, with those who are fully vaccinated numbering more than 20% of their populations.

EMA also revisited the use of J & J vaccine

The disturbing reports come at a time when the European drug regulatory agency, the European Medicines Agency, has revisited the use of the AstraZeneca vaccine, produced by Oxford University and the British/Swedish firm AstraZeneca.

That inoculation has been linked to cases of thrombosis and several deaths throughout the EU. Last week, the EMA looked at its safety once again; while stating that the AstraZeneca product was indeed linked to certain cases of thrombosis, these were very few in comparison to the numbers of people who had received it.

The EMA ruled that the EU should continue with the inoculation campaign, considering that the public good of the vaccine outweighed any risks entailed in receiving it.

The sudden action taken by the federal regulators of the FDA and CDC will throw a curve ball to states’ lightning-fast vaccination campaigns, which are geared toward a rapid pace of inoculations as the coronavirus variants continue to multiply.

Another issue complicating the situation is vaccine hesitancy, which has been reported as an issue for as many as 40% of some military branches. White evangelicals in the South are also much more hesitant than the norm to receive a coronavirus vaccination.

Move could lead to increased vaccine hesitancy

The news regarding the AstraZeneca vaccine in Europe has also complicated matters, as some Americans saw the issues with that inoculation for a reason to shun all vaccines from any source.

The majority of the vaccines in the United States are manufactured by Pfizer/BioNTech and Moderna, which are currently supplying upwards of 23 million doses every week of their two-shot inoculations.

As of now, no significant safety concerns have been reported regarding either the Pfizer or the Moderna shot.

But Tuesday’s move comes as a blow to American vaccine programs, since the J & J shot did not have to be stored in the ultra cold temperatures needed by the other shots, and only one dose was needed for protection.

Just these aspects alone made the J & J shot perfectly suited for use in mobile vaccination clinics and those sponsored by community organizations and municipal facilities, such as local fire departments and so on.

The Johnson & Johnson product was the last on the American vaccine market, and its numbers have lagged behind the other two makers. But so far, more than 7 million people have received the J & J inoculation, and it was featuring in the upcoming vaccination clinics both in the US and in Europe, to which the firm was expecting to send millions of doses this Spring.

EMA says cases could be seen as a “safety signal”

The Johnson & Johnson vaccine first came in for scrutiny on April 9, when the European Medicines Agency said it was investigating reports of four cases of blood clots in people who received the Johnson & Johnson vaccine in the United States.

One case had already occurred in the clinical trials that took place before the vaccine was authorized for emergency use and three occurred in the vaccine clinics after authorization. One of the cases was fatal.

The regulators said that these reports could be seen as a “safety signal” — a group of cases requiring further investigation.

At the time, Johnson & Johnson responded with a statement saying “At present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine.” Janssen is the name of the Johnson & Johnson division that developed the vaccine.

The CDC also evaluated the incidents occurring in Colorado, Georgia, Iowa, and North Carolina, with reports of dizziness, light headedness, and rapid breathing, Kristen Nordlund, a CDC spokeswoman, told the Associated Press.

On Saturday, North Carolina and Iowa both resumed their inoculation campaigns featuring the J & J vaccinations after temporarily suspending the programs last week after several people had immediate reactions to the shots.

In North Carolina, several people reportedly passed out after receiving the vaccine near Raleigh and Chapel Hill. At least 26 people reported experiencing adverse reactions, and four North Carolinians were taken to hospitals for further examination.

At this point, it is unknown how much of an effect the pause in J & J inoculations will have on the Biden administration’s plan to inoculate all American adults by the end of May.