IThe epidemic response to the US-dominated epidemic by the Mistakes of No, the attempt to develop a vaccine to prevent Covid-19 has so far been a success. Vaccines against the coronavirus that cause the disease are now running through huge clinical trials as a result.
There is a terrible irony after that that the Trump administration’s statements have eroded public confidence, what percentage of Americans tell Polster that they will vaccinate Kovid-19 and that the President’s concerned experts could force the Food and Drug Administration to prepare a vaccine before it is ready. To allow. (Spoiler: No vaccine is likely to be ready by election day.)
“When the president comes out and says, ‘On a very special day, let’s get vaccinated,’ the whole thing is blown up,” said Ashish Zai, dean of Brown School Public Public Health. At 19 State Health Tech Summit. “In some ways, we let politicians down and let scientists talk about this and run this process.”
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The decision-making process when a vaccine seems safe and effective is not as simple as the general public believes. But it is important to understand if we are to believe in these crucial tools to help prevent epidemics.
Here, it is a prediction of science that goes into the decision-making process, telling us about when those results may actually become available and start giving vaccines. The story is based on interviews as well as detailed submissions of drug manufacturers’ clinical trial plans.
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When will vaccine manufacturers have enough data?
Clinical trials are usually sponsored by a company making a vaccine candidate or an educational institution, or a partnership of both. But it is actually overseen by what is known as the Data and Safety Monitoring Board or DSMB, a group of independent experts appointed to ensure the volunteers in the study are safe. In many studies, DSMB has the ability to recommend stopping treatment, only if the treatment is unsafe, but if it is so clearly effective that simply continuing is not ethical.
In the case of vaccine trials, studies conducted by Modern, AstraZeneca and Johnson and Johnson share a common DSMB with the National Institutes of Health. The study, conducted by Pfizer and its partner Bioentech, has its own.
DSMBs will do what will be known as interim analysis after being infected with Covid-19 and showing symptoms. Each of these cases is considered an “event,” and each vaccine manufacturer sets a variety of events as thresholds for interim analysis as part of their trial protocols.
The study, conducted by Pfizer and its partner Bioentech, conducted its first interim analysis after 32 events leading up to the vaccine race, and the vaccine would be considered effective if 26 people from the placebo group and six people from its vaccine group were covid. . The study of the Movirna vaccine, another front-runner, will wait until 53 cases of covid come.
In the case of Pfizer and Bioentech, interim analyzes may take place in mid-October.
After showing its effectiveness on the basis of 32 cases of Covid-19, for millions of people, should the vaccine be approved?
Some experts say no. Eric Topol, director of the Scripps Research Translational Institute, is adamant that all trials should continue until the end of their design – while Covid has about 1 case0 – even number 1Makes sense in statistics, but it makes sense.This is especially true if efficacy is limited, if all vaccines often produce side effects such as fever.
Others say that while it is better to make a decision based on an interim analysis, the first Pfizer analysis, in particular, determines a relatively low bar for effectiveness given the low number of events.
The numbers correspond to past vaccine studies. Prevner 13 was approved to prevent pneumonia in adults with a total of 139 cases of pneumonia based on a study of 1,000,000 people, 90 of whom were in the placebo group.
But there is also a prerequisite for such studies to continue to collect more security data. Researchers studying Rotatech collected data for a vaccine to prevent the virus from causing childhood diarrhea, rejecting the potential side effects of 70,000 patients, as seen with the previous vaccine.
Rules of approval
If and when a company believes its vaccine is safe and effective, it will then submit its data to the Food and Drug Administration.
No Covid-19 vaccine is likely to be fully approved by the FDA in the near term, as manufacturers may need and years to follow-up. The FDA is expected to use a separate authority, providing what is known as emergency use author authorization or EUA.
The bar for the EUA is low, and the previous EUA did not suddenly understand. Paramivir was given on an emergency basis to treat hospitalized patients during H1N1 swine flu in 2009; In later clinical trials of such patients the drug failed to show efficacy. Hydroxychloroquine was given to the EU for the treatment of covid-19 in hospitalized patients; Subsequent studies showed that they did not benefit from the drug, leaving the authorization behind. EUA for data involving convective plasma that never passes muster for approval. Examples behind this are precisely why many experts are so concerned that FDA decisions are being politicized.
The challenge for the FDA will be to ensure that it brings its general standards for vaccines into the process of authorizing more flexible emergency use.
It usually takes one year to review a drug candidate’s data, six months if it is fast and three months fastest. The truncated review should also take weeks. So even if data is available on Pfizer’s vaccine in mid-October, it’s hard to imagine an emergency clearance by election day. The same is true if data from a study of the AstraZeneca vaccine taken outside the US
He assumes, of course, that politics does not work.
Will the trials go ahead?
The interim analysis says that the drugs that most people follow are used, as soon as a clear result comes, the trial stops. But plans for the Covid-19 vaccine are different: data may be released from an interim analysis if a vaccine is mistakenly considered effective – but volunteers will not be told immediately whether they are getting the vaccine or a placebo. In other words, the study will be “blind.” Participants receiving placebo will not be immediately turned over to the vaccine.
“The protocol is designed in such a way that even if we can file it after an interim analysis, the protocol is designed to move forward for at least some time,” said Catherine Jensen, Pfizer’s head of vaccine research. The reason for the recent call with journalists is that there is a need to assess effectiveness in small groups such as adolescents, the elderly and people living with HIV, he said. Jensen said Pfizer and Bioentech also hope to gather information about serious infections.
The trial may be difficult to follow after an interim analysis, as one of the top in the clinical trial statistics is Thomas Fleming, co-written A 2008 paper on what should be avoided.
In a conference call with reporters to discuss the start of Johnson and Johnson’s study for the vaccine, Anthony Fawcett, who led research on infectious disease at NIH, said that half of the volunteers in the study will continue to be effective in other tests. Therefore, follow up for at least two months.
Only 20 cases of Covid-19 are required in Jammu and J before the interim analysis is conducted. But Johnson and Johnson’s chief scientific officer, Paul L. Stoffels, told STAT that his company would wait for an interim analysis until half of the 60,000 volunteer studies, which began this month, were followed up for two months. Such an analysis would require adequate data in other populations, including the elderly. After interpretation of the data, the DSMB may recommend discontinuation of the study.
“Generating enough information is also where we take our responsibility, because in the end we will be responsible for getting the product to market,” Stuffles said.
“You know, we have 600,000 people out of a thousand, maybe 100 million to 500 million,” Stauffels said. “The information we produce should be very solid.”
The point is that regulators, and especially politicians, need to remember how eager they are to get their hands on the vaccine.
