WASHINGTON, Dec 12: The US will start vaccination against covid with the world's first vaccine, Pfizer-BioNTech's mRNA vaccine, on Monday, it was officially announced on Saturday. All high tech cold storage (minus 70 deg C) arrangements required by this vaccine are in place.

The UK was the first country to launch covid vaccination with the world's first vaccine, Pfizer's, last Tuesday. A few other countries have since given the emergency use authorisation (EUA) for Pfizer vaccine although it has come to light that four volunteers had developed Bell's palsy during trials.

On Monday, 145 sites in the US will have the vaccine, 425 more sites will get it on Tuesday and the last 66 sites on Wednesday, according to Gustave Perna, in-charge of distribution.

One person needs two doses with a gap of three weeks. It should start working in seven days. This is the quantum required for all the upcoming covid vaccines irrespective of the technology used, except Johnson & Johnson which needs only one jab. Pfizer's needs to be stored under minus 70 deg C and this poses a challenge for distribution.

In the first phase in the US, 3 million people will be administered the vaccine, healthcare workers and other vulnerable sections getting the top priority, although the States will take the final decision.

Trump threat to FDA chief

The FDA had on Friday night given the emergency use authorisation. The approval followed a nasty drama staged by President Donald Trump through White House Chief of Staff Merk Meadows who threatened FDA Commissioner Stephen Hahn he will lose his job if the vaccine is not approved immediately. So the approval came by night, same Friday. On Thursday the expert panel had okayed it. December 10 was FDA's review date for EUA.

However, the FDA advised allergy patients to avoid the vaccine for the time being. Common side-effects are fatigue and headache.

The vaccine is claimed to be 95% effective although there is no way to prove a vaccine is effective unlike a medicine which cures a disease within a time limit. Prevention is difficult to prove except by a process of deduction and that is why it is said it takes usually a decade for a vaccine to be cleared.

The proof of the pudding is in the eating. A vaccine has to be safe (1) in the first place, which can be proved in course of time, then it should have the efficacy (2) for prevention, which is a deductive process taking a decade's time, and then, thirdly, it should prevent transmission (3).

Is Pfizer's a vaccine

Enthusiasm and excitement will not stand in for a solution to health issues like the current pandemic. Pfizer does not guarantee against transmission. It guarantees the other two - safety and efficacy up to 95%. But actual proof is success in the field over the years.

A basic question remains unanswered. Can Pfizer's mRNA vaccine be called a vaccine. It is not a vaccine in the conventional sense. In conventional method, an attenuated or deactivated virus or part thereof is injected into human beings producing immunogenicity in the body, training the body to adequately respond when the actual infection occurs.

mRNA is a new technology being used in human beings for the first time. Two more pharmas are using this tech: US' Moderna (vaccination likely to begin in the US after possible approval by FDA on December 27) and Gennova in India.

Pfizer's uses this technology, and so it is not a vaccine, it is a genetic code of instruction taken from coronavirus. It is carried to the human cells. The cells in turn produce the "vaccine" which the immune system recognises as foreign body and responds and is thereby trained. "The (mRNA) code instructs cells in the body to make the virus's distinctive 'spike' protein," which works as the vaccine, the FDA said. Obviously this triggers functional changes in human cells.

What they call as engineered transcription. Will it go awry one day and set off genetic changes? That will have catastrophic impact on the human race itself. To rule out such adverse effects, mRNA technology needs be on clinical trials for at least twenty years. It's something analogical to the GM technology of which there is no final word yet.

Pfizer did not take funds from US Operation Warp Speed programme and it has signed a deal with the US worth $2b for 100 million doses with option for 500 m more. The US also made a deal with Moderna on Friday for 100 m doses with option for 300 m more. Moderna was working with the US National Institutes of Health for the vaccine development.

Meanwhile, on Saturday the US recorded a toll of 3,309 covid deaths in the 24 hours, the highest for a day anywhere so far. The infection and death rates are alarmingly going up in the US while elsewhere the situation is easing tremendously.