Nine vaccine brands have signed a joint promise to maintain “high moral criteria and sound clinical principles” in progression and possible vaccines opposed to COVID-19.
They also pledged to seek government approval for a vaccine “after demonstrating protection and efficacy through a phase III clinical study. “
Those who have signed this commitment are AstraZeneca, BioNTech, GlaxoSmithKline, Johnson
He occurs when President Donald Trump continues to push for a vaccine opposed to COVID-19’s guilty coronavirus to be quickly approved.
“We’re going to get a vaccine very soon, even before a special date. You know what date I’m talking about,” he said at a CNN press conference Monday, referring to Election Day on November 3.
Comments through Trump and others through senior U. S. fitness officialsBut it’s not the first time They have raised fears that a COVID-19 vaccine could be caused by political reasons.
Dr. Stephen Hahn, commissioner of the Food and Drug Administration (FDA), said in an interview with the Financial Times that the company would possibly receive emergency authorization for the use of a COVID-19 vaccine before the trials are completed. Phase 3 clinics.
However, he told vaccine developers to apply for this permit.
Herschel Nachlis, PhD, assistant professor of government studies and scholar at Nelson A Center. Rockefeller’s Public Policy and Social Sciences at Dartmouth College is that political tension about the FDA is rare.
“Regulatory decisions are combinations of politics and politics,” he said, “and this time it won’t be any different. “
However, it said that vaccine brands seemed to perceive the desire for decisions on the COVID-19 vaccine to be based on the quality of knowledge and integrity of regulatory processes.
“One feature of this commitment is that corporations say they will not be asked to submit erroneous knowledge, or to submit knowledge that does not result in the protection and efficacy of vaccines, to the FDA,” he said.
Peter Loge, an associate professor of media and public affairs at George Washington University, says vaccine brands are interested in insisting that their vaccines be rigorous.
“Real remedies charge cash [for pharmaceutical corporations] to grow,” he said. “If there are no domestic or foreign popular and effective treatments, corporations that spend the resources to do well will temporarily lose a percentage of the market to corporations that do not. be careful to make sure your claims are true. “
The press release of the nine vaccine brands called their commitment “historic”, as it is so for competing companies to work together.
However, Loge argues that this collaboration replaces independent federal regulation.
Public aptitude observers “fear that industry self-regulation will make independent review even more difficult,” he said. “The [vaccine manufacturers’] commitment is probably smart for public fitness, but there is an explanation as to why the FDA exists. “
Pfizer and BioNTech, AstraZeneca and the University of Oxford, as Modern and the US National Institute of Allergy and Infectious Diseases. But it’s not the first time They have candidate vaccines in complex phase 3 trials.
These studies will recruit thousands of volunteers and are the only way to know if a COVID-19 vaccine is effective.
Volunteers will get the candidate vaccine or an inactive placebo; some vaccines require two doses spaced several weeks apart. Researchers will have to wait until participants are exposed to the virus, which takes time.
Phase 3 trials are unlikely to be completed before Election Day, but vaccine brands may have sufficient knowledge to apply for an emergency use authorization (USA) for your vaccine, an option they have included in your commitment.
A USA is reserved for public fitness emergencies, such as a pandemic. This still requires an FDA review of clinical trial data, but the company just needs to know that a vaccine has a very likely benefit. This is a lower threshold than that required for traditional approval.
After Trump pushed hydroxychloroquine, a decades-old malaria drug, as a remedy for COVID-19, the FDA released an AMERICA for the drug and related chloroquine. Subsequently, the firm revoked this authorization due to lack of benefits and an increasing number of cases. serious side effects.
More recently, the FDA released a U. S. for convalescence plasma after Trump promoted the remedy as a breakthrough; however, evidence of its effectiveness is inconclusive and a trained panel convened through the National Institutes of Health stated that there was no adequate evidence for this approval.
Hahn of the FDA has muddied the waters by overestimating the effects of studies of this treatment.
Nachlis co-wrote a recent article in JAMA magazine on how the kinds of lessons learned from the FDA’s missteps with US hydroxychloroquine can simply be implemented to make the screening of a COVID-19 vaccine more transparent.
“Some other people are concerned about Array . . . that the popular US review itself is vague, as are the popular US ones for transparency,” Nachlis said, “and that’s why, in the short and long term, it may be vital for the FDA to explain the review and transparency processes of the EUA and citizens.
Tobias Gerhard, PhD, associate professor of pharmaceutical practice and management at Rutgers Ernest Mario School of Pharmacy, is less involved in whether the vaccine is approved by the U. S. or conventionally, and more on whether the knowledge used to make this resolution is public. Available.
“The authorization of emergency use, or popular approval, in the absence of public knowledge or on the basis of unconvincing knowledge would be incredibly problematic,” he said, “and would most likely seriously damage the ongoing COVID-19 reaction and the public health. “
Even if the FDA issues an EUA for a COVID-19 vaccine, drug brands will want to continue to monitor the other people who have won the vaccine to make sure it is safe.
While mild effects, such as inflammation or pain at the injection site, appear to be in smaller trials, rarer adverse occasions may not be detected until tens of thousands of people have won a vaccine.
A co-trial of the COVID-19 vaccine, a collaboration between AstraZeneca and Oxford University, was already discontinued after a player in the UK was diagnosed with transverse myelitis, according to the New York Times.
This inflammatory condition affects the spinal cord and can be triggered by a viral infection; it is not known if this diagnosis is similar to that of the AstraZeneca vaccine.
These types of interruptions are not unusual for clinical trials, so studies are frequently monitored through awareness and protection committees, an organization of independent scientists, and nongovernmental researchers.
But fitness economist Joshua P. Cohen, PhD, wrote on Twitter that this “inconvenient” highlights the desire to rush a vaccine.
“Perhaps this dose of truth will allow others to perceive the imaginable barriers that are happening,” he wrote. “But it’s also not useful for politicians” to promise a vaccine until the end of the year. “It’s better to wait and see. “
The FDA has scheduled a public assembly of its Advisory Committee on Vaccines and Related Biological Products on October 22, less than two weeks before Election Day. During this assembly, the firm will share some of the knowledge collected in the Phase 3 trials.
This assembly may simply alleviate some of the public’s concerns about a politicized vaccine approval process, which was highlighted in a recent STAT-Harris poll.
In the poll, 72% of Republicans and 82% of Democrats believe the procedure is based more on politics than science.
In addition, 80% of Republicans and 85% of Democrats said they would be involved in protecting a vaccine if it was passed quickly.
By committing, vaccine brands seem to be addressing some of the public’s concerns.
Pfizer CEO Albert Bourla said Tuesday on NBC’s Today show that the commitment to uphold the highest moral standards for vaccines stems from “growing public fear about the processes we use to expand those vaccines and, what more importantly, the processes that would be used to compare them. ” vaccines. “
Loge says that succeeding this time is not just about fighting the COVID-19 pandemic, but about what will happen in the future.
“A rushed vaccine that isn’t is a dreadful and dreadful idea,” he said. “More people will die and public confidence in government, science and industry will diminish. This means that the next time there is a pandemic, and there will be an upcoming one, it will be even more difficult to respond.
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