Like three other companies with Covid-19 vaccine candidates undergoing phase 3 clinical trials, Johnson & Johnson, on Wednesday, released elaborate documentation of its clinical trial protocol (it has the largest phase 3 trials of all the candidates so far, about 60,000 people). This unprecedented level of disclosure, which has never happened before, so this is an appropriate and perhaps unprecedented use of the word misused, comes amid fears that vaccine developers may take shortcuts in their race to develop a vaccine against the coronavirus disease, or allow themselves to be pressured by the political establishment to launch vaccines that are not ready. Vaccines must prevent infection, reinfection, and most importantly, be safe – one of the reasons it typically takes years to create one. Sure, the crisis posed by the pandemic has shortened the timeline, perhaps permanently. If a vaccine for Covid-19 is available in the middle of next year, and it is certain that at least one will be, then there is a high probability that no new vaccine for any disease will take the 7-10 years it used to be. in the BC era (before Covid). But you still need to check boxes for safety and efficacy.
The four companies – Pfizer, Moderna, AstraZeneca, and Johnson & Johnson – are also signatories to a commitment to ensure “high ethical standards and sound scientific principles,” and not to seek regulatory approval for their vaccines until dozens of clinical trials are conducted. thousands of individuals demonstrate that (vaccines) are effective and safe. Five other companies, GlaxoSmithKline, Merck, Novavax, BioNTech and Sanofi, also signed this pledge. Among these, BioNTech is working with Pfizer on the vaccine.
The vaccine, like the mask, has become a political issue in America. After the country’s drug regulator, the Food and Drug Administration, said it is considering adjusting its vaccine approval process to include outside experts, US President Donald Trump, who has been pushing for a vaccine. Before the November elections, he said Wednesday that this sounded like “a political move.” Just in case, he added that if the FDA makes the changes, the “White House” may or may not “approve.”
The potential consequences of vaccine developers or regulators giving in to political pressure could be disastrous, which is why the compromise and disclosures: With four major companies launching theirs, other vaccine developers have no choice but to share your own protocols; Failure to do so is likely to be controversial and will also cast a shadow over the judgments themselves, they are important.
A reading of the protocols shows (warning: they do a heavy reading) that the J&J trial is the only one that measures the efficacy of the vaccine in preventing severe and critical cases of Covid-19. As Peter Doshi and Eric Topol noted in an op-ed in The New York Times earlier this week, the protocols for clinical studies of the Moderna, AstraZeneca, and Pfizer vaccine candidates say that “a vaccine could meet the companies benchmark whether it reduced the risk of mild Covid-19, but was never shown to reduce moderate or severe forms of the disease, or the risk of hospitalization, intensive care unit admissions, or death. ” William Haseltine, a former Harvard Medical School professor who now heads a group of health experts, wrote in The Washington Post, pointing to the same concern. “… the protocols should increase anxiety rather than alleviate it. Careful reading suggests that clinical trials have been designed to ensure the greatest possible success for these candidates, and may overstate their effectiveness. ”Haseltine was commenting on Moderna and Pfizer’s clinical study protocols, the first to be published.
There is also another big difference between Johnson & Johnson vaccine and the other three: it requires refrigeration but does not need to be frozen. Ensuring that things stay frozen during transport and storage presents a significant challenge, especially in many developing countries (including India, where the problem is compounded by its size) (see page 9).
Over the next several weeks and months, more vaccine candidates are expected to launch their Phase 3 trials. According to the HT Vaccine Tracker, there are 18 vaccines in Phase 2 trials. There are another 6 in Phase 3 and 5 have been approved for use. of emergency.
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