Covid-19: What you need to know today
All four companies — Pfizer, Moderna, AstraZeneca, and Johnson & Johnson — are also signatories to a pledge to ensure “high ethical standards and sound scientific principles”, and to not seek regulatory approval for their vaccines till clinical trials on tens of thousands of individuals show them (the vaccines) to be effective and safe.
Like three other companies with Covid-19 vaccine candidates undergoing Phase 3 clinical trials, Johnson & Johnson, on Wednesday, made public the elaborate documentation of its clinical testing protocol (it has the largest Phase 3 trials of all candidates yet, around 60,000 people). This unprecedented level of disclosure — it’s never happened before, so this is an apt and perhaps unprecedented use of the oft-misused word — comes amidst fears that vaccine developers could cut corners in their race to develop a shot for the coronavirus disease, or allow themselves to be pressured by the political establishment into launching vaccines that are not ready. Vaccines have to prevent infection, reinfection and, most importantly, be safe — one reason why it usually 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 by the middle of next year — and it is definite that at least one will be — then there is a high likelihood of no new vaccine for any disease ever taking the 7-10 years it used to in the BC (before Covid) era. But it still needs to check boxes on safety and efficacy.
All four companies — Pfizer, Moderna, AstraZeneca, and Johnson & Johnson — are also signatories to a pledge to ensure “high ethical standards and sound scientific principles”, and to not seek regulatory approval for their vaccines till clinical trials on tens of thousands of individuals show them (the vaccines) to be 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 the US. After the country’s drug regulator, the Food and Drug Administration, said it is considering tightening its vaccine approval process to include outside experts, US President Donald Trump, who has been pushing for a vaccine ahead of the November election, said on Wednesday that this sounded like “a political move”. For good measure, he added that if FDA makes the changes, the “White House” may or may not “approve it”.
The potential consequences of either vaccine developers or regulators giving in to political pressure could be disastrous, which is why the pledge and the disclosures — with four large companies having released theirs, other vaccine developers have no option but to share their own protocols; not doing so will likely prove controversial and also cast a shadow over the trials themselves — are important.
A reading of the protocols shows (warning: they make for heavy reading) that the J&J trial is the only one measuring the efficacy of the vaccine in preventing severe and critical cases of Covid-19. As pointed out by Peter Doshi and Eric Topol in an opinion piece in The New York Times earlier this week, the protocols for the clinical studies of the Moderna, AstraZeneca and Pfizer vaccine candidates say that “a vaccine could meet the companies’ benchmark if it lowered the risk of mild Covid-19, but was never shown to reduce moderate or severe forms of the disease, or the risk of hospitalisation, admissions to the intensive care unit, or death”. Writing in The Washington Post, William Haseltine, a former Harvard Medical School professor who now runs a health think tank, flagged the same concern. “...the protocols should heighten anxiety rather than alleviate it. A close reading suggests the clinical trials have been designed to ensure the greatest possible success for these candidates — and could overstate their effectiveness.” Haseltine was commenting on the Moderna and Pfizer clinical study protocols, the first to be released.
There is also another big difference between the Johnson & Johnson vaccine and the other three — it requires refrigeration but does not need to be frozen. Ensuring things stay frozen during transportation and storage presents a significant challenge, especially in many developing countries (including India, where the problem is compounded by sheer size) (see page 9).
Over the next few 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 emergency use.