The Pfizer-BioNTech Coronavirus Vaccine: Is It a Game Changer?

“Today is a great day for science and humanity.”

This is what Albert Bourla, Pfizer CEO, said while announcing the company’s first successful interim data from its ongoing vaccine trials in response to COVID-19.

The sheer amplitude of that remark coupled with its “Neil Arm-strength” gives it a certain interstellar significance, considering the intra-planetary expanse of the virus.

The news of the Pfizer vaccine (claimed to be 90% effective) comes at a crucial time, with global casualties from the pandemic inching close to 1.3 million and second/third waves of the pandemic advancing, resulting in reimposition of lockdowns (UK, France, Portugal, South Korea etc.) and bringing major economies to a standstill, again!

What is This New Vaccine Story?

Pfizer-BioNTech Vaccine (BNT162b2) is one among the 47 COVID-19 vaccines undergoing clinical evaluation under WHO guidelines. It is being developed by American drugmaker Pfizer and its German partner BioNTech.

There are a variety of vaccines out there, differing on so many parameters (dose strength, virulent technology, mode of administration etc.). The Pfizer vaccine has employed a cutting-edge technology called messenger-RNA or mRNA that has never been approved for human vaccination before.

Unlike the dead or attenuated technology employed in other vaccines, the mRNA in BNT162b2 trains the immune system to target the spike protein found on the surface of the coronavirus. It requires two doses, approximately a month apart.

What Does 90% Efficacy Mean?

This particular study has looked at the first 94 confirmed cases of COVID-19 out of more than 43,000 volunteers. Each of the volunteers were given either two doses of the vaccine or the placebo.

Results: In fewer than 10% of the participants who were administered with the vaccine, infections were found. In contrast, more than 90% of the cases were found in people who were given placebo.

According to the company, the vaccine has an efficacy rate higher than 90% at seven days after the second dose. This indicates that after a person is vaccinated, he/she develops immunity 28 days thereafter.

Good News? How Good?

The US Food and Drug Administration had said that it would expect at least 50% efficacy from any COVID-19 vaccine. Judging by those terms, the Pfizer study results have been overwhelmingly successful.

Although the initial excitement over the results is running high, a lot of questions remain unanswered. Major data on the subject classes composition are yet to be released.

(For example, how long will its immunity last, whether it reduces contagions in recipients, does its efficacy prove equal in groups like the pregnant and the elderly etc.)

Question of Availability

There are many different stages to clear before a vaccine is approved for marketability.

Till date, TWO COVID-19 vaccines (Sputnik V and EpiVacCorona) have been released, both in Russia and both without entering Phase 3 clinical trials.

Pfizer is targeting a production of 50 million doses this year and 1.3 billion in 2021. Interestingly, this vaccine was NOT developed as part of Operation Warp Speed.

However, the US Government has invested $1.95bn in the manufacturing process of this vaccine. The distribution albeit would have to be taken care of by the company itself.

It’s Not Going To Be That Easy

There are considerable headaches to be faced in the process of delivery.

One, getting regulatory approval from recipient nations before shipping starts will be tricky, especially in light of the novel never-before-used m-RNA technology. Countries will, perhaps, want to run indigenous tests and trials that may inevitably warrant elongated timelines.

Two, the vaccine requires storage at or below minus 70 degrees Celsius (-94 degree F). That is a tremendous logistical issue, not only for developing nations, but even in the Western world, given the shortage of reliable cold chains.

Third, in India, the government had an “initial meeting” with Pfizer’s Indian subsidiary late August but still hasn’t entered a formal partnership to ensure supply or to set up a dedicated manufacturing facility. In these circumstances, an arrangement called “fill and finish” (putting vaccine into vials and packaging) is likely, which is usually an operation outsourced to third-parties and raises complications in the manufacturing process.

Nevertheless, the results are promising. With major breakthroughs occurring everyday, it’s too early to wager on the Pfizer vaccine’s success. Fingers crossed.

(Originally published November 11th 2020 in transfin.in)