When was the J&J COVID vaccine approved?
On February 27, 2021, Johnson & Johnson subsidiary Janssen Pharmaceuticals received Emergency Use Authorization from the FDA allowing its COVID-19 vaccine to be distributed in the U.S. for use in individuals 18 years of age and older. Johnson & Johnson’s vaccine became the third COVID vaccine to be granted EUA by the FDA during the pandemic.
What is Emergency Use Authorization (EUA)?
In a public health emergency, such as the global coronavirus pandemic, the FDA’s Emergency Use Authorization, or EUA, accelerates the manufacturing and approval process so that the public can gain access to the medical product faster. However, public safety must remain paramount in this process and administration of the vaccine.
Once manufacturers submit an EUA request, the FDA evaluates the request and determines whether the relevant statutory criteria are met. This includes considering all of the scientific evidence about the vaccine available from the manufacturer.
Before the FDA approves medical drugs and vaccines, they must first undergo an extensive three-phase clinical trial process. This is also true with medical drugs that are being fast-tracked through EUA for approval. Part of the FDA’s evaluation of an EUA request for COVID-19 vaccines includes evaluation of the chemistry, manufacturing, and controls for information for the vaccine to ensure quality and consistency.
EUAs remain in effect until circumstances determine the authorization can be safely terminated. While under EUA, vaccines may be revised or revoked. Meanwhile, manufacturers that receive EUAs are expected to continue clinical trials to obtain additional safety and efficacy information and to pursue full FDA approval.
Why did FDA Grant EUA Approval to the J&J COVID Vaccine?
The FDA approved the J&J single-dose COVID vaccine based on an analysis of 39,321 participants enrolled in an ongoing, randomized, placebo-controlled study conducted in South Africa, certain countries in South America, Mexico, and the U.S., who did not have evidence of COVID-19 prior to enrolling in the study.
About half the participants received the vaccine and the other half were given a saline placebo. Overall, the vaccine was found to be about 67% effective in preventing moderate to severe/critical COVID-19 at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical COVID-19 at least 28 days after vaccination.
What are the side effects of the Johnson and Johnson COVID vaccine?
Since the Johnson & Johnson COVID vaccine received approval, some recipients have experienced two serious side effects—a rare form of blood clots and a neurological disorder.
On April 13, 2021, the FDA and the U.S. Centers for Disease Control and Prevention (CDC) announced that they were reviewing six cases in the U.S. of a rare and severe type of blood clot in individuals who had received the Johnson & Johnson COVID-19 vaccine. The blood clots were a type known as cerebral venous sinus thrombosis (CVST) and were seen in combination with low blood platelet levels (thrombocytopenia). The condition later became known as thrombosis with thrombocytopenia syndrome, or TTS.
All six cases occurred in women between the age of 18 and 48, and symptoms occurred from 6 to 13 days after vaccination. Due to the seriousness of the health risk, the FDA and CDC asked states to temporarily halt using J&J’s COVID vaccine as they investigated further.
Ten days later, the agencies confirmed that the FDA’s adverse event reporting system received a total of 15 cases of TTS. All cases occurred in women between the ages of 18 and 59, and all had fallen ill between 6 and 15 days after the J&J vaccination. Despite these findings, the FDA and CDC recommended resuming use of the J&J COVID vaccine.
Since May 12, 2021, 28 cases of TTS have been reported including three deaths. Among the 28 cases of TTS, 19 involved the brain with 10 of those patients suffering from a cerebral hemorrhage. Others experienced clots in the lower extremities, pulmonary arteries, or other parts of the body.
Symptoms of thrombosis with thrombocytopenia syndrome include:
- Severe headache
- Visual changes
- Abdominal pain
- Nausea and vomiting
- Back pain
- Leg pain or swelling
- Easy bruising or bleeding
On July 13, 2021, the FDA announced that it was revising the vaccine provider fact sheets for J&J’s COVID vaccine to include information about an increased risk of Guillain-Barré Syndrome (GBS) in individuals after receiving the vaccine. GBS is a neurological disorder in which the body’s immune system damages nerve cells. It causes muscle weakness and, in severe cases, paralysis. Most people who develop GBS recover over time, but for some, symptoms linger.
As of July 13, 2021, the FDA said it had received 100 preliminary reports of GBS following administration of J&J’s COVID-19 vaccine, including one death. Of those 100, 95 of were considered serious and required hospitalization.
GBS following J&J COVID vaccination was reported from two weeks to 42 days after vaccination, and appeared to affect primarily men age 50 years or older. No similar symptoms have been identified in people who have received the Moderna or Pfizer-BioNTech COVID-19 vaccines.
Symptoms of Guillain-Barré Syndrome include:
- Weakness or tingling sensations, especially in the legs or arms that worsens or spreads to other parts of the body.
- Difficulty with facial movements including speaking, chewing, or swallowing.
- Difficulty walking;
- Double vision or inability to move eyes.
- Difficulty with bladder or bowel function.
Is J&J’s COVID Vaccine Different From Moderna’s and Pfizer’s?
It usually takes about 10-15 years for vaccines to go through all the research and testing involved in developing them. But due to the FDA’s emergency use authorization in light of the coronavirus pandemic, the process was accelerated. Newer technology also helped speed the development of some vaccines.
Most vaccines, including Johnson & Johnson’s COVID-19 vaccine, are made using virus-based technology. Specifically, these vaccines use a disabled adenovirus to teach the body to recognize and destroy disease-causing agents.
Conversely, Moderna and Pfizer-BioNTech COVID-19 vaccines use Messenger RNA (ribonucleic acid), or mRNA, technology. These vaccines work by delivering instructions to cells that empower them to produce antigens to fight viruses. This process significantly cut down on the development phase which got the vaccine into human clinical trials much faster than traditional vaccines.
Manufacturing Problems with Johnson & Johnson COVID Vaccine
In early 2021, weeks before the Johnson & Johnson vaccine received Emergency Use Authorization, workers at an Emergent BioSolutions plant in Baltimore manufacturing J&J’s vaccine along with AstraZeneca’s vaccine, which has not yet been authorized for use in the U.S., accidentally mixed up the ingredients between the two vaccines.
Up to 15 million doses of J&J’s vaccine were contaminated and had to be destroyed. This forced regulators to delay authorization of the plant’s production lines which delayed shipments of J&J’s vaccine while the FDA launched an investigation. This raised serious questions about the training and supervision of workers at the plant and whether J&J was cutting corners in order to get its vaccine on the market quicker.
In August, months before J&J’s vaccine was granted EUA, the company struck a $1 billion deal with the U.S. government to produce 100 million doses of the vaccine once it was cleared by the FDA. As we noted earlier, nearly a year before the debacle at the manufacturing plant that resulted in the contamination of millions of J&J vaccines, the Emergent BioSolutions plant was found in violation of following proper procedures. Records were not secured, testing procedures were violated, and measures to prevent contamination and mix ups were not up to par
J&J COVID Vaccine Side Effects Lawyers
Beasley Allen attorneys are currently investigating cases of rare blood clots known as thrombosis with thrombocytopenia syndrome, or TTS, and a neurological condition called Guillain-Barré Syndrome, in people who have received the Johnson & Johnson COVID-19 vaccine.