PFIZER Inc’s experimental COVID-19 vaccine is more than 90% effective based on initial trial results, the drugmaker said on Monday, a major victory in the war against a virus that has killed over a million people and battered the world’s economy.
Scientists, public health officials and investors welcomed the first successful interim data from a large-scale clinical test as a watershed moment that could help turn the tide of the pandemic if the full trial results pan out.
However, mass roll-outs, which needs regulatory approval, will not happen this year and several vaccines are seen as necessary to meet massive global needs.
Pfizer and German partner BioNTech SE said they had found no serious safety concerns yet and expected to seek US emergency use authorisation (EUA) this month, raising the chance of a regulatory decision as soon as December.
If granted, the companies estimate they can roll out up to 50 million doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.
“Today is a great day for science and humanity,” said Pfizer chief executive Albert Bourla, noting the data milestone comes with “infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen.”
Experts said they wanted to see the full trial data, but 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 University of Oxford, professor of emerging infectious diseases Peter Horby.
There are still many questions, such as how effective the vaccine is by ethnicity or age, and how long it will provide immunity, with social distancing and face covering set to remain for the foreseeable future.
Pfizer expects to seek US emergency use authorisation for people aged 16 to 85.
To do so, it will need two months of follow-up safety data to assure no side effects crop up. That is expected to be available in the third week of November.
US Health and Human Services Secretary Alex Azar said it would take several weeks for US regulators to receive and process the data before a potential approval.
“The efficacy data are really impressive. This is better than most of us anticipated,” said William Schaffner, infectious diseases expert at Vanderbilt University School of Medicine in Nashville, Tennessee.
“The study isn’t completed yet, but nonetheless the data look very solid.”
President-elect Joe Biden said the news was excellent but did not change the fact that face masks, social distancing and other health measures would be needed well into next year.
The World Health Organisation called the results very positive, but warned there was a funding gap of US$4.5 bil that could slow access to tests, medicines and vaccines in low- and middle-income countries.
There are other challenges as well that could affect less affluent countries.
The Pfizer vaccine must be shipped and stored at an extremely cold temperature, which requires necessary infrastructure. That highlights the need for more traditional vaccines in development, such as J&J’s candidate.
The European Union said on Monday it would soon sign a contract for up to 300 million doses of the Pfizer and BioNTech COVID-19 vaccine.
The companies have a US$1.95 bil contract with the US government to deliver 100 million vaccine doses beginning this year. They did not receive research funding from the Trump administration’s Operation Warp Speed vaccine programme.
The drugmakers have also reached supply agreements with the United Kingdom, Canada and Japan.
The interim analysis, conducted after 94 participants in the trial developed COVID-19, examined how many had received the vaccine versus a placebo.
Pfizer did not provide that detail, but over 90% effective implies that no more than 8 of the 94 had received the vaccine, administered in two shots about three weeks apart.
The efficacy rate, which could drop once full results are available, is well above the 50% effectiveness required by the US Food and Drug Administration for a coronavirus vaccine.
Shortly after Pfizer‘s announcement, Russia said its Sputnik V vaccine was also more than 90% effective, based on data collated from inoculations of the public. Its preliminary Phase III trial data is due to be published this month.
To confirm the efficacy rate, Pfizer said it would continue its trial until there were 164 COVID-19 cases among volunteers.
Bourla told CNBC on Monday that could be before the end of November.
Pfizer said its data would be peer reviewed once it has results from the entire trial.
“These are interesting first signals, but again they are only communicated in press releases,” said Marylyn Addo, head of tropical medicine at the University Medical Center Hamburg-Eppendorf in Germany. – Nov 10, 2020
