On the 12th local time, US media reported that due to unexplained symptoms of participants, Johnson & Johnson’s ongoing research on the new crown vaccine has been suspended.
According to the US health media STAT News, the media obtained documents issued by Johnson & Johnson to researchers. The document stated that the “suspension rule” has taken effect and the online system used to recruit patients has also been shut down. In addition, an independent committee responsible for monitoring data and security has already met on the 12th.
The vaccinators have unexplained symptoms. According to overseas websites, Johnson & Johnson confirmed in its response to the media that the study has been suspended, saying it was because “a participant had an unexplained illness” and refused to provide more. information. The company statement reads: “We must respect the personal privacy of participants. We are now understanding the symptoms, and we must sort out all the facts before sharing more information.”
However, Johnson & Johnson also emphasized that symptoms, accidents and other medical problems may all appear in clinical research. It also emphasized the difference between “study pause” and “clinical hold”, the latter being a more formal and longer-lasting regulatory action. The US media pointed out that although it is not uncommon for clinical research to be suspended, vaccine research during the epidemic is significantly more concerned.
Prior to this, Johnson & Johnson announced on September 23 that the new crown vaccine candidate developed by the company has entered clinical phase III trials. The experiment will be conducted in the United States, Argentina, Brazil, Chile, Colombia, Peru, and South Africa, and the number of volunteers will reach 60,000.
A source said that under this scale, even if the problem is resolved this time, a new situation may arise.
In fact, Johnson & Johnson is not the first company to encounter twists and turns in clinical trials.
In early September, the University of Oxford/AstraZeneca stated that AstraZeneca had suspended clinical trials of the new crown vaccine due to a suspected serious adverse reaction in a British clinical trial participant. After the news came out, AstraZeneca’s stock price fell 8% after the market.
However, after a six-day shutdown, the Oxford University/AstraZeneca Phase III clinical trial of the new crown vaccine was restarted in the UK. The University of Oxford said that after a quick assessment, the Independent Safety Evaluation Board and government regulators believe that it is safe to continue to vaccinate people.
Once successful in rhesus monkeys and hamsters, the current new crown vaccine is in the stage of accelerating research and development.
In the research and development of overseas companies, adenovirus vector vaccines and mRNA vaccines have made the most rapid progress. In the adenovirus vector epidemic, the vaccine products of Oxford University/AstraZeneca and Johnson & Johnson entered clinical phase III trials; in nucleic acid vaccines, BioNTech/Pfizer’s mRNA vaccines and Moderna’s mRNA vaccine entered clinical phase III trials.
In July, Johnson & Johnson announced in the journal Nature that the company’s new coronavirus vaccine candidate, Ad26.COV2.S, triggered an immune response in preclinical studies in non-human primates (NHP). The study of “Nature” shows that Ad26.COV2.S only needs to be vaccinated once, which can not only stimulate powerful neutralizing antibodies and cellular immune responses in non-human primate models, but also achieve the goal in subsequent challenge experiments on animals. The effect of complete protection or almost complete protection.
A group of researchers led by Dr. Dan H. Barouch, an immunologist at the Beth Israel Deaconess Medical Center (BIDMC), conducted a study in 52 rhesus monkeys: using 7 different versions of the adenovirus serotype 26 vector COVID-19 One of the vaccines (hereinafter referred to as Ad26 vaccine) gave 32 adult rhesus monkeys a single dose, and provided a sham vaccine to another 20 rhesus monkeys as a placebo control. All rhesus monkeys vaccinated with Ad26 produced neutralizing antibodies. Six weeks after vaccination, all rhesus monkeys were exposed to SARS-CoV-2. All 20 rhesus monkeys that received the fake vaccine were infected and showed high levels of virus in their lungs and nasal swabs. Among the 6 rhesus monkeys vaccinated with the best candidate vaccine Ad26.COV2.S among the Ad26 vaccines, none of the rhesus monkeys had the virus in the lungs, and only one rhesus had low levels of the virus in the nasal swabs .
On September 4, Johnson & Johnson announced that Ad26.COV2.S has achieved new positive results in preclinical studies. The data published in Nature Medicine on the same day showed that Ad26.COV2.S triggered the production of neutralizing antibodies in Syrian golden hamsters and prevented severe clinical symptoms of new coronary pneumonia, including weight loss, pneumonia and death.
Received a $1 billion bet by the U.S. government. According to The Paper, citing PR Newswire reports, on August 5 this year, Johnson & Johnson announced that its subsidiary Janssen Pharmaceuticals had reached an agreement with the U.S. government on large-scale domestic production and delivery. After approval or emergency use authorization by the Drug Administration (FDA), 100 million doses of the new crown vaccine Ad26.COV2.S will be produced and used in the United States on a large scale.
Johnson & Johnson pointed out in the news that the U.S. Biomedical Advanced Research and Development Agency (BARDA) and the U.S. Department of Defense will invest more than $1 billion in implementing this agreement. According to the subsequent agreement, the US government can also purchase another 200 million doses of the new crown vaccine.
In early October, according to Reuters, the European Commission stated that it had reached a supply agreement with Johnson & Johnson to supply its candidate new crown pneumonia vaccine to up to 400 million people. This is also after the EU reached a deal with AstraZeneca and Sanofi. The third pre-purchase contract signed with the COVID-19 vaccine manufacturer.
It is reported that the EU is using about 2 billion euros from an emergency fund to try to finalize pre-purchase agreements with a number of vaccine manufacturers to secure sufficient vaccine supplies for the EU’s 450 million population.
“Secondary infection” enhances the urgency of vaccines According to Worldometer’s real-time statistics, as of about 6:30 on October 13, Beijing time, a total of 8034799 cases of new coronary pneumonia have been confirmed in the United States, and a total of 219,998 deaths. Compared with the data at 6:30 the previous day, there were 42,801 new confirmed cases and 303 new deaths in the United States.
The latest forecast from the Institute of Health Metrics and Evaluation of the University of Washington shows that by February 2021, the number of new coronary pneumonia deaths in the United States may increase by another 181,000. Anthony Fauci, the chief infectious disease expert in the United States, said when talking about predictions that he hoped that the shocking numbers would make the public realize the importance of epidemic prevention.
In an interview with CNN on the 12th, Fauci pointed out: “I hope these figures…make the American people realize that we can’t let this kind of thing (a surge in deaths) happen, because the epidemic in the United States is getting worse now. As we enter the cold season, this is the most terrifying thing.”
On October 12, the authoritative core medical journal “The Lancet” published a paper titled “Genomic Evidence for Reinfection of New Coronary Pneumonia: A Case Study”, stating that a 25-year-old man in the United States became the first case of secondary infection with new crown in the United States. Cases, and the second infection was more serious than the first.
According to the paper, this is a 25-year-old resident of Wausau County, Nevada, USA, 6 weeks between the two infections. On April 18 this year, the patient tested positive in the community. During the follow-up in May, the patient was tested again and the two tests showed negative results. However, on June 5, the patient’s test results were again positive.
It is worth noting that the patient’s second infection of the virus has changed compared with the first time, and the symptoms of infection are more serious than the first time. They need supplemental oxygen and are admitted to the hospital after shortness of breath.
The paper pointed out that patients who have previously been infected with the new coronavirus may not be able to ensure that they are fully resistant to the virus in all cases. Therefore, for everyone, regardless of whether they have been diagnosed with COVID-19, they should take the same precautions to avoid infection.
The example of this man warned the medical community about how long people can stay immune after contracting the new crown and how effective the vaccine is.
The researchers said that reports of reinfection suggest that achieving widespread population immunity to the new coronavirus without a vaccine may be challenging.
Paul Hunter, a professor of medicine at the University of East Anglia, commented: “Most of us (scientists) believe that as individual immune levels decline after infection, secondary infections of the new coronavirus may become very common.”
Akiko Iwasaki, professor of immunobiology at Yale University, said that secondary infections tell us that people cannot rely on the immunity gained from natural infections to obtain herd immunity, and “herd immunity still needs safe and effective vaccines.”
It is worth noting that on October 11, local time, US President Trump tweeted: “Yesterday I received a full and complete signature from the White House doctor. This means that I will not get the new crown (immunization) again, nor will I be infected. . Glad to know this.” Later, this tweet was marked by Twitter as a misleading statement.
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