In a significant development in a statement drugmaker Pfizer Inc said, its experimental COVID-19 vaccine has been effective more than 90%, as per initital trial results. The development marks a major victory in the war the Wuhan coronavirus-induced COVID19 pandemic which has killed more than a million people globally and has brought the growth of the global economy to its knees.
Welcoming the first successful interim data from a large-scale clinical test as a watershed moment, public health officials, scientists and investors, said it could help turn the tide of the pandemic once the full trial results come out. However, a mass rollout will require regulatory approval, which is unlikely to be given this year. Several vaccines are seen as necessary to meet surging global needs.
In a statement, Pfizer and its German partner BioNTech SE stated they had found no serious safety concerns yet; they expect to tap U.S. emergency use authorization later this month, which raises the chances of a regulatory decision, as early as December.
Once regulatory approval has been granted, companies estimate that they can roll out as many as 50 million doses this year which is enough to protect 25 million people; they can produce up to 1.3 billion doses next year.
“Today is a great day for science and humanity,” said Pfizer Chief Executive Albert Bourla while noting that the data milestone comes with “infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen.”
While experts have asked for the full trial data, they said the preliminary results looked encouraging.
“This news made me smile from ear to ear. It is a relief to see such positive results on this vaccine and bodes well for COVID-19 vaccines in general,” said Peter Horby, professor of emerging infectious diseases at the University of Oxford.
There are yet many unanswered questions, including how effective is the vaccine is by ethnicity or age and for how long does it provide an immunity.
“But the bottom line is, as a vaccine it’s more than 90% effective, which is extraordinary,” said top U.S. infectious diseases expert Dr. Anthony Fauci.
In a statement, U.S. Health and Human Services Secretary Alex Azar stated, it would take several weeks for U.S. regulators to receive and process the clinical trial data before providing any potential approval.
There are a couple of challenges that have to be met which are likely to affect less affluent countries. Pfizer’s vaccine will have to shipped and stored at an extremely cold temperature which necessitates expensive infrastructure. Even many U.S. hospitals lack these super cold storage units which is likely to impact the distribution and vaccination process, especially in rural areas.
Despite these challenges, in an interview, Bill Gruber one of Pfizer’s top vaccine scientists said “I’m near ecstatic. This is a great day for public health and for the potential to get us all out of the circumstances we’re now in.”
In a statement, German health minister Jens Spahn said, around 55% to 65% of the population will need to be vaccinated to break the COVID-19 spread cycle. He went on to add, he does not expect a shot to be available before the first quarter of 2021.
The European Union is slated to soon sign a contract for up to 300 million doses of the Pfizer and BioNTech COVID-19 vaccine.
Both companies have made a $1.95 billion contract with the U.S. government to deliver 100 million vaccine doses beginning this year. Incidentally, they did not receive research funding from the Trump administration’s Operation Warp Speed vaccine program.
Both companies have also entered into supply agreements with Japan, the UK and Canada.
The Pfizer and BioNTech vaccine uses messenger RNA (mRNA) technology, which relies on synthetic genes that can be generated and manufactured in weeks, and produced at scale more rapidly than conventional vaccines. The technology is designed to trigger an immune response without using pathogens, such as actual virus particles. The Trump administration has said it will have enough vaccine doses for all of the 330 million U.S. residents who want it by the middle of 2021.