Britain is currently holding its breath as regulators draw ever-closer to approving the Pfizer/ BioNTech vaccine.
The news comes after Health Secretary Matt Hancock on Friday, November 20, asked British regulators to start assessing the Pfizer BioNTech vaccine, as the company filed for emergency authorisation in the US.
Both the Pfizer/ BioNTech and Moderna are in competition to become to first COVID-19 jab to be implemented across Europe.
Pfizer/ BioNTech submitted their emergency application to the European Medicines Agency on Monday, November 30, while Moderna submitted their application just one day later, on Tuesday, December 1.
If all is successful, the Pfizer/ BioNTech will, therefore, be the first vaccine to be approved, as the European Medicines Agency aims to complete its evaluation of the vaccine by December 29, subject to the level data available. Meanwhile, reports suggest the Moderna vaccine will be approved on January 12, two weeks later.
Pfizer said their vaccine is 95 per cent effective in preventing Covid-19 and has passed its safety checks.
If the application is approved, first deliveries may begin within hours, and jabs may begin as soon as December 7.
This brings the total number of doses ordered from Moderna by the Government to seven million, with a further 100 million doses ordered from Oxford, and 40 million doses from Pfizer BioNTech. An overall total of 357 million doses from seven different developers havs been ordered by the Government.
The Oxford vaccine, developed with AstraZeneca, can prevent on average 70.4 per cent of people from getting Covid-19, according to new data from late-stage trials in Britain and Brazil.
AstraZeneca said they will immediately prepare a submission for regulatory authorities and seek an Emergency Use Listing from the World Health Organisation.
Almost 200 vaccines have been put into development since January, with at least 15 in human trials, and the UK has invested in three main jabs. Here’s what you need to know about each one.
How the three main vaccines compare: at a glance
What’s the latest on Oxford’s AstraZeneca vaccine?
Overall results from phase three of the Oxford AstraZeneca trial show the vaccine is 70.4 per cent effective on average. But when administered at a half dose and then a full dose the vaccine can be up to 90 per cent effective.
When delivered in two full doses it produced 62 per cent effectiveness.
The study, involving more than 24,000 volunteers, showed there were no serious cases among those who received the vaccine, including no hospitalisations, the researchers said.
On Wednesday, November 25, Oxford University and AstraZeneca shared a manufacturing error which now raises questions around the initial results of their vaccine.
Just days after the company labelled the vaccine as “highly effective”, they released a statement which explained the error. However, it neglected to mention why some participants did not receive as much of the vaccine in their first two shots as they had anticipated.
The volunteers who received the lower dose were better protected than those who had received the two full doses. Surprisingly, the 90 per cent effective in the lower dose group, while it was 62 per cent effective among the higher dose participants. With the results of the two groups combined, it was approximately 70 per cent effective.
Dr Andrew Pollard said the team expects to report final results from late-stage trials by Christmas.
What we know about the Pfizer vaccine
US Pharmaceutical company Pfizer and German biotech firm BioNTech said their vaccine is 95 per cent effective in preventing Covid-19 and has passed its safety checks, with no severe side effects beyond fatigue which affected 3.7 per cen of participants.
The UK government asked the independent regulator (MHRA) to assess the vaccine, and Pfizer have said they will submit their data to regulatory agencies around the world, aiming to produce 1.3 billion doses in 2021.
Whilst Oxford created a traditional vaccine, Pfizer’s relies on a live piece of genetic code which must be kept at minus 70 degrees Celsius, making it less convenient and more expensive.
It is therefore expected that the initial doses will be administered in hospitals and NHS staff will likely be the first to benefit, potentially beginning as early as Wednesday, should approval be granted by the Medicines and Healthcare products Regulatory Agency.
MHRA Chief Executive, Dr June Raine said on Monday, Nov 23 that it had received further data from Pfizer/BioNTech.
“It is our job now to rigorously assess these data and the evidence submitted on the vaccine’s safety, quality and effectiveness.”
What else do we know about the Moderna vaccine?
The Moderna coronavirus vaccine may offer very high levels of protection against Covid-19 and there appears to be no evidence efficacy is worse at older ages, primary analysis for the final phase of the study suggests.
Moderna have reported that vaccine efficacy against the disease was 94.1pc, with efficacy against severe Covid-19 was 100pc. The jab is also well tolerated according to the report and there have been no serious safety concerns identified to date.
The analysis of the phase three of the COVE study of the vaccine candidate, called mRNA-1273, involved 30,000 participants. Of this figure, 196 were Covid-19 patients, 30 of which were severe.
The UK has ordered seven million doses of the vaccine, produced by the US firm. This is enough to vaccinate around 3.5 million people. The study has now exceeded two months of median follow-up post-vaccination.
The US biotech firm’s vaccine has yet to be approved by regulators, but doses could begin being delivered next spring if it meets the standards.
Peter Openshaw, Professor of Experimental Medicine at Imperial College London, said the trial included many high-risk or elderly people, which gave him confidence the vaccine will help those most in need of it.
Unlike the Pfizer jab, the Moderna vaccine can be kept for six months at -20C, the temperature of a conventional freezer, and can be stored for up to 30 days in a standard fridge – but a dose is three times larger than Pfizer’s.
Everything we know about the Sputnik vaccine
Moscow claims its Sputnik-V candidate has reached 92 per cent efficacy in phase three trials of more than 16,000 volunteers.
The World Health Organisation (WHO) is in talks with the Russian institute that developed the Sputnik V candidate vaccine concerning its potential application for Emergency Use Listing.
The Russian Direct Investment Fund (RDIF), which has been backing the vaccine, said there were no unexpected adverse events during the trials, and monitoring of the participants is continuing.
The results have not yet been peer-reviewed.
The Telegraph has revealed that Britain is likely to reject a vaccine from Russia, amid serious concerns over its trial processes.
What about the Imperial College vaccine?
Researchers at Imperial have developed a candidate which, when injected, will deliver the genetic instructions to muscle cells to make the SARS-CoV-2 spike surface protein. This should provoke an immune response and create immunity to the virus.
The Imperial human challenge trial is being run by hVivo, a spin-off company from Queen Mary University of London. Already roughly 2,000 people have signed up to take part in challenge studies in Britain through the group 1Day Sooner.
Those testing the vaccine will be given the jab and will then wait a month for antibodies to build. The volunteers will then be exposed to the virus.
Rather than giving people a weakened form of the illness, the Imperial vaccine instead uses synthetic strands of genetic code based on the virus’ genetic material.
What do we know about China’s Sinovac vaccine?
Sinovac, the Chinese pharmaceutical firm, says its vaccine is nearly ready and will be rolled-out across the world early next year.
Beijing was so confident in its homegrown inoculations that authorities had been administering vaccines for more than a month before clinical studies conclude, authorities revealed at the beginning of September.
Some are concerned about the quality of the vaccines and on November 9, Sinovac was forced to suspend trials of its vaccine in Brazil after a participant died.
Who will get the vaccine first?
The provisional timetable – which depends on the authorisation and arrival of millions of vaccines, is as follows:
Care home residents and staff, healthcare workers – from beginning of December;
Ages 80 plus – from mid-December;
Everyone aged 70-80 and ‘clinically extremely vulnerable’ people from late December;
Everyone aged 65-70 – from early January;
All high and moderate risk under 65s – from early January;
Everyone aged 50-65 – from mid January; and
Everyone aged 18-50 – from late January; but with the bulk of this group vaccinated during March.
The plan would see 88.5 million vaccination doses delivered across England, with two doses per person over the age of 18, by the end of April.
People who were told to shield throughout the pandemic, who are at very high risk of catching coronavirus due to previous health problems, have been given the same priority access as those aged 70 and over, Public Health England has announced.
Anybody over the age of 18 who is categorised as “clinically extremely vulnerable” will therefore receive the same vaccine at the same time as those over 70, according to the official provisional vaccine priority list.
Pressure may mount on political leaders to vaccinate their citizens first, but an inequitable distribution of vaccines globally could prolong the pandemic for everyone. Read the Telegraph’s full analysis here.
Will the vaccines be ready for Christmas?
Those who are categorised as the highest priority may receive the Pfizer vaccine before Christmas, according to a deputy chief medical officer in Downing Street.
The NHS has been instructed to prepare for a mass Covid-19 vaccination of the public from December 1, with plans to dispense 1,000 jabs a week at 1,500 GP practices and drive-through centres.
Medical and nursing students, and retired medics, are being drafted in to help. Chair of the Royal College of General Practitioners, Prof Martin Marshall, suggested dentists should join them to allow other treatments to continue.
The NHS is in the process of establishing vaccination centres across the country that can manage the logistical challenge of storing the Pfizer vaccine, and in addition is establishing vaccination hubs in hospitals for NHS staff.
A mass rollout of Covid-19 vaccinations is expected to start on December 9 in Nottingham and Nottinghamshire, but only if the vaccine is approved by the Government.
On November 28, Boris Johnson appointed Nadhim Zahawi as a health minister responsible for the deployment of the coronavirus vaccine.
Downing Street announced that the Stratford-on-Avon MP, who already serves as a business minister, would take on the role until at least next summer.
He will temporarily relinquish responsibility for most areas of his brief at the Department for Business, Energy and Industrial Strategy (BEIS).
How do vaccines work, how long do they take to make, and why?
A vaccine stimulates your body’s immune system to produce antibodies and fight off a disease, and are determined to be effective or not by comparing infection levels in a vaccinated group of people and a control group.
Here’s the journey a vaccine takes, from initial development to approval:
- Before clinical testing: At this stage, scientists test the vaccine on cells and then give the virus to animals. If the vaccine produces an immune response – ie if antibodies are produced – it can move to the next stage
- Phase 1 testing: In these tests, also known as safety trials, the vaccine is tested on a small number of people. It is in this stage that scientists work out the dosage and if the jab produces an immune response in humans
- Phase 2: Now the vaccine is tested on a lot more people, with hundreds of participants split into groups, often by age. Sometimes, to speed up the process, phases 1 and 2 can be combined.
- Phase 3: In the third phase of testing, the vaccine is delivered to thousands of people. The vaccine runs alongside a placebo. This phase is extremely important because it simulates mass adoption of the vaccine; the larger sample size of participants means that the trial can find out rare potential side effects of the vaccine that might not be present in smaller groups. The Oxford and Imperial vaccines are currently at this stage.
- Approval: If the vaccine passes through these stages, it can be approved by national and international regulators. Then it can be distributed. Scientists would continue to monitor people who receive the vaccine, in case it is not safe. However, researchers have expressed concern that approval could be rushed without adequate scrutiny – as with China and Russia’s vaccines – or that emergency authorisation of a coronavirus vaccine could be dangerous. Approval is also subject to political pressures
What is a ‘challenge’ trial?
Volunteers could soon be deliberately infected with coronavirus in trials to speed up a vaccine and discover if people are protected if they have already had the disease, in what is known as a “challenge trial”.
In a groundbreaking trial, scheduled to begin in January at the Royal Free Hospital in London, patients will be inoculated with a vaccine developed by Imperial College, and then exposed to coronavirus.
“Challenge trials” are controversial, but can give a quick answer about whether a vaccine is effective and several Nobel laureates have called for them to take place.
Oxford University is also intending to use a similar “challenge trial” to test whether people have protective immunity from the disease if they have been previously infected.
Both groups of researchers are currently hunting for a “salvage therapy” that would be given as a last resort if the vaccine did not work before they can begin the trials and will need approval. The trials will be funded by the Government.
Will I be able to travel overseas once vaccinated?
Ministers are in discussion over the use of ‘vaccine stamps‘, which could be issued to an individual’s passport following inoculation with a coronavirus vaccine.
The Department for Transport are considering using passport stamps as proof of vaccination in order to prevent hold ups at borders should travel pick up in the new year, providing a boost to the aviation industry.
Source: The Telegraph Travels