Pfizer and BioNTech have announced that their vaccine candidate against COVID-19 achieved 90% effectiveness in protecting against Covid-19 in the first interim analysis from the phase 3 COVID-19 vaccine trial.
The company says it can manufacture 50m doses this year, and 1.3bn in 2021.
The UK Government has so far secured 30 Million doses of the vaccine which requires a booster shot. Pfizer says it can manufacture 50m doses this year, and 1.3bn in 2021.
ALBERT BOURLA Chief Executive Officer of Pfizer Said “I am happy to share with you that Pfizer and our collaborator, BioNTech, announced positive efficacy results from our Phase 3, late-stage study of our potential COVID-19 vaccine. The vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis.
The results demonstrate that our mRNA-based vaccine can help prevent COVID-19 in the majority of people who receive it. This means we are one step closer to potentially providing people around the world with a much-needed breakthrough to help bring an end to this global pandemic.
This is a first but critical step in our work to deliver a safe and effective vaccine.
It’s important to note that we cannot apply for FDA Emergency Use Authorization based on these efficacy results alone. More data on safety is also needed, and we are continuing to accumulate that safety data as part of our ongoing clinical study.
We estimate that a median of two months of safety data following the second and final dose of the vaccine candidate – required by FDA’s guidance for potential Emergency Use Authorization – will be available by the third week of November.
We are also generating data to show that our vaccine can be consistently manufactured to meet quality standards.
Efficacy, safety and consistent manufacturing are the three requirements that are needed before we are able to file for authorization.
We look forward to sharing additional updates in the coming weeks and will continue to work closely with regulatory authorities to provide access to our anticipated vaccine for those who need it most.
I want to thank the thousands of people who volunteered to participate in the clinical trial, our academic collaborators and investigators at the study sites, and our colleagues and collaborators around the world who are dedicating their time to this crucial endeavor.
We could not have come this far without the tremendous commitment of everyone involved. Their dedication and courage are the reasons we continue to believe that science will win.
Thank you all.”
Prof Fiona Watt, Executive Chair of the Medical Research Council, said:
“This is very encouraging news – and provides grounds for optimism that other vaccines will also show benefits. What really strikes me though is the fantastic contribution of the many volunteers who have taken part in the trial, including over 40% from diverse backgrounds – without their altruism the trial could not have gone ahead.”
Prof Eleanor Riley, Professor of Immunology and Infectious Disease, University of Edinburgh, said:
“At face value, this is exceptionally good news: a vaccine that is 90% effective at preventing symptomatic cases of COVID-19 and with millions of doses available by the end of the year.
“However, the full data set on which the claim is based has not yet been released and so we don’t know exactly what has been found. The two companies are at pains to point out that the trial participants are ethnically diverse, which is good, but say nothing about the age of people in the trial. If a vaccine is to reduce severe disease and death, and thus enable the population at large to return to their normal day-to-day lives, it will need to be effective in older and elderly members of our society. We also know nothing yet about the severity of cases that were seen in the trial, whether infection or infectiousness was prevented, or how long the immunity is expected to last.
“But, I think we have reason to be cautiously optimistic.”
Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said:
“These provisional results look promising and this is a great encouragement for all the vaccines under trial. However, once again we have a press release without detailed data, even on the provisional result, but 90% efficacy is definitely good news, but there is some uncertainty. It is not known whether the efficacy is constant across age groups, and it is results in the elderly that are required for the first use of the vaccine in high risk people.
“It seems difficult in the light of an encouraging finding to raise concerns. The fact that the DSMB should release results but also continue the trial recruitment is unprecedented in my experience. It is going to make recruitment more difficult and the ethics of continuing to randomise people to placebo within this trial may be questioned. It may also lead to pressure to vaccinate the placebo group with the Pfizer vaccine. This will mean that the longer term follow-up within the properly randomised trial will become difficult, and it may be the longer term where the true benefit and harm balance will need to be assessed.”
“It’s encouraging news, but the process does not seem to have followed usual procedures, and that might leave some concerns.”
