Covid-19: What you need to know today
Regular readers of this column are aware that my reading of scientific journals and papers increased significantly (actually went from 0 to 60 in under 10 seconds, to borrow a metaphor from the automobile business) during the coronavirus disease pandemic.
With a handful of vaccines for Covid-19 clearing Phase 3 trials; the vaccination of the general population in the UK beginning on Tuesday; and an indigenously developed vaccine applying for emergency use authorisation (on the basis of Phase 1/2 data, but more on this shortly), I was reminded of a May article in the British Journal of Pharmacology that claimed that identifying a drug or drugs to treat the coronavirus disease would take less time than the 12-18 months it would take to develop a vaccine. It has been a year and 10 days between the first published account of the strange illness in Wuhan, China, and the administration of a vaccine that has cleared Phase 3 trials to a member of the general population, so the authors of that article got that right. But they got the drugs bit completely wrong.
A clutch of antiretrovirals that initially showed promise do not work. Nor does hydroxychloroquine (HCQ). Remdesivir mostly does not work. Ditto with most autoimmune therapies. And plasma therapy, too, does not seem effective in most cases. Monoclonal antibodies may work, but the treatment is expensive. Indeed, the only drugs that have been conclusively proven to work in the treatment of Covid-19 are steroids such as dexamethasone. That does beg the question as to why hospitals are continuing to treat people with some of these (expensive) drugs and therapies, but I shall move on in the spirit of caveat emptor and all that...
Still, it is surprising that we now have not one or two, but a bouquet of successful vaccines that can prevent Covid-19, but just one drug that can treat it.
Then there are the promising vaccine candidates, among them, Covaxin, Bharat Biotech’s Made in India one that applied for emergency use approval on Monday. I’m a little surprised by the application for regulatory approval. The company started its Phase 3 trials on November 11. According to available information, the trial involves injecting people with two doses of the vaccine or a placebo at a 28-day interval and then waiting for 14 days to test for efficacy. That would mean that even interim data from the Phase 3 trials will become available only in late December. It also suggests that the regulatory approval is being asked for on the basis of the unpublished (so far) Phase 1/2 data. If the company wanted to apply for emergency use approval on the basis of this, it could have done so at any time and it is not clear why it has waited till now.
To be sure, the very fact that the company has moved from the combined Phase 1/2 to Phase 3 trials, and that these were approved by the drug regulator, suggests that the results of Phase 1/2 were successful, that the vaccine provoked an immune response in the small sample of people tested. But as much as I’d love to see a local vaccine become available soon — the benefits of this are huge — it is important that due process is followed. The developer, and its partner, the Indian Council of Medical Research, must release the Phase 1/2 data. And the drugs regulator may do well to wait for at least interim data from the Phase 3 trials before approving the vaccine.
More a digression than a post script: My colleague and the person who has edited more of these columns than anyone else in the newsroom used to be one of the country’s top sports journalists. His usual feedback on my column is along two dimensions. One, on the quality of the column itself, and whether, in his opinion, it has covered fresh ground (getting tougher as the number keeps increasing, I can tell you). And two, on the cricketing significance of the number — he started doing this after Dispatch crossed the 100 mark. But even I know the significance of 221 (today’s number): it was Sunil Gavaskar’s epic double century in an unsuccessful fourth innings chase of 438 (needed in 445 minutes and 20 mandatory overs) at The Oval. The match was eventually drawn, with India falling nine runs short, and with two wickets in hand. Many consider it Gavaskar’s finest innings ever. Some believe the match saw India’s best chase ever. It also challenged the limits of possibility. Just as vaccine development has.