Tag: Pfizer

Boris Johnson: ‘Tonight, that toot of the bugle is louder’

Prime Minister’s statement on coronavirus (COVID-19): 9 November 2020

Across the country and around the world this evening, people are asking one question about our fight against Covid. Does the news of progress towards a vaccine that’s been announced today mean we are at the beginning of the end of our troubles?

So, let me set out our assessment.

The Pfizer/BioNTech Vaccine has been tested on over 40,000 volunteers and interim results suggest it is proving 90 per cent effective at protecting people against the virus.

But we haven’t yet seen the full safety data, and these findings also need to be peer-reviewed.

So we have cleared one significant hurdle but there are several more to go before we know the vaccine can be used.

What I can say is that if and when this vaccine is approved, we, in this country, will be ready to start using it.

Earlier this year the UK Government ordered 40 million doses of the Pfizer vaccine – enough for about a third of the population, since you need two doses each.

That puts us towards the front of the international pack on a per capita basis – and I should add we’ve ordered over 300 million doses from 5 other vaccine candidates as well.

If the Pfizer vaccine passes all the rigorous safety checks and is proved to be effective then we will begin a UK-wide NHS led programme of vaccine distribution.

We will decide the order in which people are offered the vaccination taking account of recommendations from a group of scientific experts, the Joint Committee on Vaccination and Immunisation.

They’re looking at a range of factors, including the different characteristics of different types of vaccines, to work out the most effective way to protect as many people as possible and save as many lives as we can.

And we will be setting out more detail about that in due course.

But – and you know I am going to say this – I must stress, these are very, very early days.

We have talked for a long time, or I have, about the distant bugle of the scientific cavalry coming over the brow of the hill. And tonight that toot of the bugle is louder. But it is still some way off.

And we absolutely cannot rely on this as a solution.

The biggest mistake we could make now would be to slacken our resolve at such a critical moment.

On Friday, SAGE reported that the R is above 1 in England – though this does not take into account the current national restrictions.

Alas, the death figures are tragically rising, running at an average of over 300 a day – sadly double where they were 24 days ago

The number of Covid patients in hospital has risen from just over 10,000 two weeks ago to nearly 13,000 on 5 November, and we are heading towards the levels of the previous peak.

Irrespective of whether there is a vaccine on the way or not we must continue to do everything possible right now to bring the R down. And that is why we hope and believe that mass testing will help.

Our first pilot began in Liverpool on Friday, in partnership with Liverpool City Council.

We’ve tested thousands of people there but there are still a lot more to do, so please if you are in Liverpool, get yourself along to a testing centre – there are 19 at the moment with more still to come.

The more people get tested the better we can protect that great city, and drive the disease down in Liverpool so do it for your friends, for your relatives, for your community.

And I want to thank the fantastic support of the army, the people of Liverpool and Liverpool City Council.

And we are now going further by sending out hundreds of thousands of rapid lateral flow tests to local authorities right across England – and also of course to the Devolved Administrations.

We’re also working with universities to establish, as soon as possible, similar mass testing capacity for students up and down the country.

But while we are making progress this project is still in its infancy.

And neither mass testing nor progress on vaccines –both vital arrows in our epidemiological quiver, both key parts of our fight against Covid – are at the present time a substitute for the national restrictions, for social distancing, for hand hygiene and all the rest.

So it is all the more important to follow the rules.

I know it’s been a tough first weekend of these Autumn restrictions and I’m especially grateful to the Royal British Legion and all those who worked so hard to ensure that no virus would stop us yesterday from honouring the memory of those who gave their lives for our freedom.

But we must get through this to 2nd December, when these measures expire and we plan to move forward with a tiered approach.

Remember the basics, hands, face, space, and the follow the rules: that is how we can together protect our NHS, save lives and get this virus back in its box.

And that is what we will do.

So thank you.

COVID VACCINE BREAKTHROUGH

‘Today is a great day for science and humanity’

The first effective vaccine against coronavirus vaccine can prevent more than 90% of people from getting Covid-19, a preliminary analysis shows. The vaccine developers, Pfizer and BioNTech – have described it as a “great day for science and humanity”.

  • 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
  • Analysis evaluated 94 confirmed cases of COVID-19 in trial participants
  • Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected
  • Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November
  • Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints

Pfizer Inc. and BioNTech SE today announced their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study.


“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla, Pfizer Chairman and CEO.

“We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen.

“With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”

After discussion with the FDA, the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases. Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC performed its first analysis on all cases.

The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.

As the study continues, the final vaccine efficacy percentage may vary. The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide.

“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,” added Bourla. “We could not have come this far without the tremendous commitment of everyone involved.”

“The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort,” said Prof. Ugur Sahin, BioNTech co-founder and CEO.

“When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality.

“We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued. I would like to thank everyone who has contributed to make this important achievement possible.”

The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8, 2020.

Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds. The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued.

The study also will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease.

In addition to the primary efficacy endpoints evaluating confirmed COVID-19 cases accruing from 7 days after the second dose, the final analysis now will include, with the approval of the FDA, new secondary endpoints evaluating efficacy based on cases accruing 14 days after the second dose as well.

The companies believe that the addition of these secondary endpoints will help align data across all COVID-19 vaccine studies and allow for cross-trial learnings and comparisons between these novel vaccine platforms. The companies have posted an updated version of the study protocol at https://www.pfizer.com/science/coronavirus.

Pfizer and BioNTech are continuing to accumulate safety data and currently estimate that a median of two months of safety data following the second (and final) dose of the vaccine candidate – the amount of safety data specified by the FDA in its guidance for potential Emergency Use Authorization – will be available by the third week of November. Additionally, participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.

Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced.

Based on current projections the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.

Pfizer and BioNTech now plan to submit data from the full Phase 3 trial for scientific peer-review publication.

Prime Minister Boris Johnson is to hold a press conference at 5pm and Scotland’s First Minister Nicola Sturgeon says the vaccine announcement is welcome news.

The First Minister ended today’s lunchtime media briefing by saying: “It might not be all that visible at the moment but there is light at the end of this tunnel.

“The news we’ve heard this morning – that early indications show a vaccine being developed by the pharmaceutical company Pfizer, which has been trialled in other countries across the world, is 90% effective – is good news.  Perhaps amongst the best news we have had in recent weeks. 

“It’s not going to provide us with the way out of this today, or tomorrow, or next week, or perhaps not even in this calendar year. But this development, along with all of the work that is going into the development of other vaccines, does give us real hope that in the not too distant future, science is going to find us the way out of this terrible time. 

“So hold onto that hope today, and also use it as a motivation. What we are living through right now, and all the restrictions that are so difficult for all of us, will not last forever. But it is really important we stick with them so that we get out of the other side of this with as few people as possible becoming ill, with as few people as possible losing their lives.

“That means all of us sticking with these tough restrictions that we are all fed up with but which we know will reduce the impact of this virus. 

“So please stick with it for now and keep hold of the hope we have today that there is an end, and that we will see it in the not too distant future.”