The vaccine is the first to be tested in the United States to
generate late-stage data
Stock markets are
booming, scientists are hailing Pfizer's
vaccine which has shown 90 percent effectiveness and corporates are already
imagining the sunny prospect of a return to on-campus work but Pfizer is
reminding everyone that it still needs to check off three boxes before its
silver bullet progresses toward emergency use authorisation.
Pfizer explains
that there needs to be "success" in the following three areas:
Evidence of efficacy in most vaccinated patients, evidence of safety with data
from thousands of patients and manufacturing which is consistently at the
highest quality standards.
Early Monday,
Pfizer and German partner BioNTech released efficacy results from a late stage
study of its Covid-19
vaccine candidate 'BNT162b2'. The company reported it was 90 per cent
effective after looking at 94 infections in a study that has enrolled more than
43,000 people in the US and five other countries. Some got the vaccine, others
got dummy shots.
The Phase 3
clinical trial began on July 27. Nearly 39,000 people have received a second
dose of the vaccine candidate by November 8, 2020.
The next milestone
for Pfizer and BioNTech is the third week of November. By then a median of 60
days of safety data will be available, as required by the FDA in its guidance
for potential Emergency Use Authorization.
The Pfizer -
BioNTech shot is one among 10 vaccine candidates in late-stage testing
globally. Moderna, another US pharma giant, is also optimistic. Dr. Anthony
Fauci, the US government's top-infectious disease expert, said today that
Moderna's vaccine is also likely to work out.
In an interview with
Bloomberg, William Moss of Johns Hopkins' International Vaccine Access Center
laid out three questions that still need answers, despite the hugely
encouraging despatch from Pfizer today: "How long does this protection
last? What kind of disease did this prevent? Was it mild or severe?"
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