Tag: Covid-19

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.” 

JVT: ‘We are at a tipping point’

The UK’s Deputy Chief Medical Officer Professor Jonathan Van-Tam outlines the current Covid-19 situation:

In our national fight against Covid-19, we are at a tipping point similar to where we were in March; but we can prevent history repeating itself if we all act now.

ONS data show that an estimated 224,000 people have the virus – up from 116,000 last week, hospital admissions for Covid-19 are rising again, as are intensive care admissions. Although the epidemic re-started in younger adult age groups in the last few weeks, there is clear evidence of gradual spread into older age groups in the worst affected areas.

Sadly, just as night follows day, increases in deaths will now follow on in the next few weeks. The good news, is that we are much more certain now that children are usually not badly affected by this virus.

The R for the UK is between 1.2 – 1.5. Roughly this means that every one case generates more than one new case, through onward transmission – so the epidemic grows larger. Every NHS region of England has an R that is well above 1.0, suggesting that widespread increases in transmission continues across the country, not just in the north of England. Scientists estimate that the doubling time in the UK for new infections is between 8 and 16 days and is even faster in some areas.

SAGE is clear that we need to act now.

Winter in the NHS is always a difficult period, and that is why in the first wave our strategy was: “contain, delay, research and mitigate” to push the first wave into Spring. This time it is different as we are now are going into the colder, darker winter months. We are in the middle of a severe pandemic and the seasons are against us. Basically, we are running into a headwind.

The NHS is bracing itself and they will do what they always do, which is work their socks off to help as many people as possible. But we need to be realistic – there is only so much they can do. We all have to help our hard-working NHS staff continue to care for everyone who needs it urgently, and provide as many non-urgent tests, checks and treatments as possible, by helping to stem the rising tide of infections.

People point out that we must not lose sight of the indirect harms of Covid-19. They are absolutely right. We need to keep elective surgeries and non-urgent services open for as long as we can; we need to keep cancer treatment and diagnostic services going; and we need to continue to provide mental health services. And importantly, we need people to come forward for that care when they need it – and we know that, during the first peak, fear of the virus put many off from doing so.

The best way we can do this is to keep the number of Covid-19 cases down. If cases rise dramatically the NHS will need to focus more on dealing with the life threatening situations immediately in front of them; this can mean freeing up staff and space by postponing other non-urgent procedures and treatments. We need to help the NHS by keeping Covid-19 numbers low; and in turn the NHS will be there for us, our families and loved ones.

The principles for how we keep transmission low have not changed. Above all else, if you have Covid-19 symptoms you must self-isolate in line with published guidance and get a test.

At all times, even when you are well, wash your hands regularly, wear a face covering in confined spaces and follow the 2 metre social distancing rules. By keeping our contacts low we reduce the number of opportunities for the virus to spread. I know this is very hard, but it is an unfortunate scientific fact that the virus thrives on humans making social contact with one another.

What I would give to have had the level of data, testing and medical insight we have now back in February and March this year. We now have much-improved testing capabilities, we know in more detail where the disease is, and we have better treatments.

Earlier in the year we were fighting a semi-invisible disease, about which we had little knowledge, and it seeded in the community at great speed. Now we know where it is and how to tackle it – let’s grasp this opportunity and prevent history from repeating itself.

Prime Minister Boris Johnson is expected to announce tougher restrictions for England tomorrow.