Johnson & Johnson on Friday announced that it was resuming a COVID-19 vaccine trials in the United States without providing enough information over what exactly led to the pause.
“The independent Data Safety and Monitoring Board (DSMB) overseeing the ENSEMBLE study has recommended resuming trial recruitment,” the company said in a statement.
“Following consultation with the U.S. Food and Drug Administration (FDA), preparations to resume the trial in the United States, including submissions for approval by the Institutional Review Boards, are now underway. Discussions with other regulators around the world to resume the clinical trial program are progressing.
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“After a thorough evaluation of a serious medical event experienced by one study participant, no clear cause has been identified. There are many possible factors that could have caused the event. Based on the information gathered to date and the input of independent experts, the Company has found no evidence that the vaccine candidate caused the event,” Johnson & Johnson added, without providing details about the event.
“At Johnson & Johnson, there is no greater priority than the health and safety of the people we serve every day around the world. Our primary goal is to ensure the safety, well-being and privacy of the participants and all those involved in our trials.
“Janssen is committed to respecting study participant privacy and the integrity of the clinical trial in which the study investigator and the participant are intentionally not informed (remain “blinded”) as to whether this participant received the vaccine candidate or placebo.
“Clinical trials are designed to evaluate safety and efficacy based on a complete view of all participants and their experiences. Unexpected adverse events, including illnesses, can occur in study participants during any clinical study, especially large studies; they can occur in both vaccine and placebo groups and require evaluation. The full safety and efficacy results will be shared at the conclusion of the trial when we can present a complete assessment of the profile of our vaccine candidate to regulatory authorities for consideration.
“In accordance with the clinical trial protocol and regulatory requirements, the Janssen study team remains blinded. This is to maintain the integrity of the data, which is essential to establish the safety and efficacy of the vaccine candidate,” Johnson & Johnson wrote.
Anxiety and many questions in Africa
Last Monday, anxiety continued to mount across Sub-Saharan Africa over the COVID-19 vaccine trials by Johnsons & Johnson, as the company continued to conceal critical details a week after one of its participants was taken ill.
Before it was paused on October 12 due to a participant’s “unexplained illness,” the trial was taking place in three continents, including in South Africa, Sub-Saharan Africa.
Despite promises for transparency, Johnson & Johnson continued to conceal basic details about what happened to a patient who was said to have fallen seriously ill after taking their coronavirus vaccine.
Johnson & Johnson stopped enrolling study participants last week while an independent monitoring board reviews details.
Many have tried to know whether the volunteer who fell ill received the vaccine or the placebo, but the New-Jersey company has continued to conceal the details.
At a press briefing last Monday, experts at the World Health Organization (WHO) in Geneva said they too had not received any details from Johnson & Johnson.
Africans have been worried about vaccine trials for a long time since Pfizer was made to pay compensations to Nigerian families affected by a controversial drug trials in 1996.
That year, 11 children died and dozens were left disabled after Pfizer gave them the experimental anti-meningitis drug, Trovan.
Those children were part of a group of 200 given the drug during a meningitis epidemic in the northern city of Kano as part of a medical trial comparing Trovan’s effectiveness with the established treatment.
Even after the children were killed, Pfizer continued to maintain for years that meningitis, not the drug, caused the deaths and disabilities.
In 2011, after a lengthy litigation process, Pfizer reached a settlement with the Kano government in northern Nigeria in 2009 and made the first payments in 2011.
With Johnson & Johnson concealing details about the vaccine trial, many worry that people may not trust the final product and refuse to take it.
Last week, Johnson & Johnson said the study was on hold because of “an unexplained illness in a study participant.” However, the company has not explained what happened and whether the person affected was in Africa.
The company said: “We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant,” the company said in a statement.
“Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians.
“Adverse events – illnesses, accidents, etc. – even those that are serious, are an expected part of any clinical study, especially large studies. Based on our strong commitment to safety, all clinical studies conducted by the Janssen Pharmaceutical Companies of Johnson & Johnson have prespecified guidelines. These ensure our studies may be paused if an unexpected serious adverse event (SAE) that might be related to a vaccine or study drug is reported, so there can be a careful review of all of the medical information before deciding whether to restart the study.
“We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.
“SAEs are not uncommon in clinical trials, and the number of SAEs can reasonably be expected to increase in trials involving large numbers of participants. Further, as many trials are placebo-controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo,” the company said.
“Last month, one of the three major worldwide coronavirus vaccine trials was paused in Phase 3 after a participant had a suspected adverse reaction. The trials for that vaccine, being developed by Oxford University and manufactured by AstraZeneca, were resumed a few days later, after a monitoring committee determined that it was safe to resume the trial,” noted the Daily News.
Last month Johnson & Johnson announced it had started a 60,000 person clinical trial of its single-dose COVID-19 vaccine on three continents, including in Sub-Saharan Africa, and that it could learn key results from the trial by early next year. The vaccine is being developed by Janssen Pharmaceutical Companies.
The final-stage trial will include 60,000 adult volunteers, those with and without comorbidities associated with an increased risk for progression to severe COVID-19, and will aim to enroll participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States.
With more than 16,000 COVID-19 related deaths and over 660,000 cases, South Africa currently has the highest death toll and number of infections in Africa, according to the latest data released on Wednesday by the Africa CDC, and Johnson & Johnson intends to carry out trials in places with high incidence of COVID-19.
The New Brunswick, New Jersey-based company said in order to evaluate the effectiveness of Janssen’s COVID-19 vaccine, countries and clinical trial sites which have a high incidence of COVID-19 and the ability to achieve a rapid initiation will be activated.
With the announcement, Johnson & Johnson has become the fourth experimental coronavirus shot to enter final-testing in the United States.
The company said it will develop and test its COVID-19 vaccine candidate in accordance with high ethical standards and sound scientific principles.
“The Company is committed to transparency and sharing information related to the Phase 3 ENSEMBLE study – including the study protocol,” J & J said in a statement.
“As COVID-19 continues to impact the daily lives of people around the world, our goal remains the same – leveraging the global reach and scientific innovation of our company to help bring an end to this pandemic,” said Alex Gorsky, Chairman and Chief Executive Officer, Johnson & Johnson.
“As the world’s largest healthcare company, we are bringing to bear our best scientific minds, and rigorous standards of safety, in collaboration with regulators, to accelerate the fight against this pandemic. This pivotal milestone demonstrates our focused efforts toward a COVID-19 vaccine that are built on collaboration and deep commitment to a robust scientific process. We are committed to clinical trial transparency and to sharing information related to our study, including details of our study protocol.”
According to Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, the company remains “fully focused on developing an urgently needed, safe and effective COVID-19 vaccine for people around the world.”
“We greatly value the collaboration and support from our scientific partners and global health authorities as our global team of experts work tirelessly on the development of the vaccine and scaling up our production capacity with a goal to deliver a vaccine for emergency use authorization in early 2021.”