New York: Global drugmakers Pfizer and BioNTech said on Wednesday they have concluded the final trials of their coronavirus vaccine and can prove it is safe and up to 95 per cent effective in preventing the disease. This is true of both mild and severe form of Covid. Also, it is equally effective in older adults, the most vulnerable group.
Pfizer said it will apply for emergency use authorization from the FDA within days, now that the final findings are known. The announcement comes just days after rival firm Moderna claimed its own jab was 94.5 per cent effective, and is an improvement on Pfizer's early estimate that the vaccine was 90 per cent effective.
This is indeed heart-warming news but how close are we in India to getting these 'safe' vaccines? Not too close, if one considers that the regulators in the US are yet to vouch for the claims made by the manufacturers.
Incidentally, both Moderna and Pfizer are using a first-time technology that's never been approved before. All these imponderables are to be taken into account before a definite timeline can be given.
Also, the race for the vaccine has just begun with not just manufacturers but also countries joining the mad scramble. Upfront are affluent countries like the US and the UK which have already tied up with the suppliers. That is grim news for countries lower down the pecking order which are yet to stick their necks out.
Then, there is a major issue of availability. If the FDA authorizes the two-dose vaccine, Pfizer has said that it could have up to 50 million doses available by the end of the year, and up to 1.3 billion by the end of next year. However, only about half of its supply will go to the United States this year, or enough for about 12.5 million people. Americans will receive the vaccine for free, under a $1.95 billion deal the federal government has reached with Pfizer for 100 million doses.
Britain has already pre-ordered 40 million doses of the vaccine and is likely to get 10m of those next month.
There are some logistical challenges with Pfizer and Moderna vaccines, especially the need to store them at cold temperatures. The Pfizer vaccine must be stored at about minus 80C, although it can be kept in a fridge for five days. Moderna's vaccine needs to be stored at minus 20C for up to six months and kept in a standard fridge for up to a month.
According to a report in the New York Times, the vaccines will probably work but making them fast will be the hard part. A part of the problem is ramping up the manufacturing capacity. Making vaccines is a complex process, requiring sterile conditions and precise control of temperature and humidity.
Both Pfizer and Moderna are using a technology involving genetic material known as messenger RNA, which allows scientists to quickly adapt the technique for new pathogens. But it has never been commercially manufactured.
Incidentally, Moderna is a small Massachusetts company that has never brought a vaccine to market.
Some companies are developing vaccines that will be easier to mass produce than Pfizer’s and Moderna’s, but they have paused their clinical trials for safety reasons, adds the report in NYT.
‘‘Let’s not lose sight of the fact that never in the history of vaccine development has a vaccine been developed at scale in this period of time,” the newspaper cited an official as saying.