The Pfizer/BioNTech vaccine against Covid-19 performs even better than previously thought, with 95% efficacy, equalling the early results from Moderna on Monday, according to an analysis of the final data from their trials, which paves the way for regulators to grant an emergency licence and vaccination campaigns to begin.
The news will excite scientists, public health experts and politicians. Pfizer/BioNTech say they also have the necessary safety data that regulatory bodies require, and will submit the vaccine for emergency approval within days to the US Food and Drug Administration and other regulators around the world.
The Pfizer vaccine, which uses innovative mRNA technology, was the first to publish an early analysis from its phase 3 trials involving 43,000 people worldwide. That analysis of 94 cases of Covid illness showed more than 90% efficacy and caused celebration around the world as it appeared clear that a vaccine was at least possible against the coronavirus that has wreaked havoc in people’s lives and countries’ economies.
The final results have been published just a week later, based on 170 people in the trial who fell ill with the disease. The new data is even better, with 95% efficacy – which means that the vast majority of those who developed symptoms and were confirmed as Covid cases had not been given the Pfizer experimental vaccine. Only eight had been given the vaccine, while the other 162 were in the placebo group.
In further excellent news, a good immune response was “consistent across age, gender, race and ethnicity demographics” and the jab had over 94% efficacy in those aged over 65, Pfizer said. That is remarkable, because many vaccines do not work so well in older people, whose immune systems weaken with age.
Of those taking part in the trial, 42% were from diverse ethnic backgrounds and 41% were aged between 56 and 85, which is also important as people from BAME groups have been disproportionately affected by the virus.
Ten of the cases resulted in severe illness, as opposed to mild symptoms, and only one of those had been given the experimental vaccine. No serious side-effect issues have been reported, although 2% of people said they suffered a headache and fatigue.
This week, the US company Moderna announced that its vaccine, which also uses mRNA, had 95% efficacy based on interim data. They will now be looking to publish final results and a safety analysis that will allow them to submit for regulatory approval.
Pfizer/BioNTech confirmed they would go within days to regulators around the world for emergency authorisation based on their final data and also manufacturing quality data. They have undertaken to deliver 50m doses of the vaccine this year, with up to 1.3bn next year. The UK has pre-ordered 40m doses and is likely to get a small amount this year. Europe has ordered 200m while the US has ordered 100mn.
“We are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against Covid-19 can be achieved very fast after the first 30 µg [microgram] dose, underscoring the potential of BNT162 to provide early protection,” said Uğur Şahin, the CEO and co-founder of BioNTech.
“These achievements highlight the potential of mRNA as a new drug class. Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against Covid-19 with a benign tolerability profile across all ages. We believe we have achieved this with our vaccine candidate BNT162b2 in all age groups studied so far and look forward to sharing further details with the regulatory authorities.
“I want to thank all the devoted women and men who contributed to this historically unprecedented achievement. We will continue to work with our partners and governments around the world to prepare for global distribution in 2020 and beyond.”
Prof Trudie Lang from the Nuffield Department of Medicine at Oxford University, said the data that has been released looked very positive.
“This is a remarkable and very reassuring situation that we find ourselves in. To go from identifying a new virus to having several vaccines at the point of applying for regulatory approval is an incredible milestone for science.
“Having worked on vaccine development in several diseases such as Malaria, TB and Ebola, I am really encouraged. The progress here, the faster ways of working and the new technologies developed can be taken forward into other vaccine programmes and benefit other diseases.”
