The UK has become the first country in the world to approve a Covid-19 vaccine candidate based on an independent review of large-scale trial data. While this is fantastic news and a vital step towards the country's economic and social recovery, scientists and public health officials are clear that this is the beginning, not the end, of that road. Health Secretary Matt Hancock has said current restrictions will not be loosened until phase 1 vaccination (approximately 30 million people) is complete.
Speaking at the Downing Street briefing on 2nd December 2020, Jonathan Van-Tam called for the UK to be ‘patient and realistic’ about the speed with which this will happen: supply of the approved Pfizer BioNTech vaccine is limited and rollout will be challenging, not least because it must be stored at -70 degrees centigrade. If phase 1 is to be completed (as is hoped) by the spring, at least one additional vaccine candidate will need to come online before the New Year.
Employers running routine asymptomatic testing to prevent workplace outbreaks will likely need to continue until at least April 2021; as will those preparing to kick off programmes in the wake of Christmas household mixing.
Vaccine candidates: the current UK situation
There are around 200 vaccines in development globally. To date, the UK Government has agreed access to a total of 357 million doses from 7 different producers. However, it is the trial results from the three ‘front-runners’ (Pfizer BioNTech, Oxford University AstraZeneca and Moderna) that have dominated the headlines in recent weeks.
Of these, the Pfizer BioNTech vaccine has been approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the Oxford / AstraZeneca vaccine is currently under review. Moderna’s vaccine candidate would not be available in the UK until the spring and as such there has been no formal request from the government for it to undergo emergency assessment. The four remaining candidates are still some way from approval: Novavax, GSK / Sanofi Pasteur and Janssen all have vaccines in phase 3 or 2/3 trials with interim results expected during Q1 2021, after which (assuming they are successful), approval could be sought. Valvena’s vaccine candidate is still in preclinical trials.
The UK has agreed access to 40 million doses of the Pfizer/BioNTech vaccine, which requires two shots, three weeks apart and gives protection 28 days after the first. 800,000 doses are currently being brought in from Belgium and, with rollout beginning next week, the first batch of recipients should be protected from Covid-19 by early-mid January. A further 10 million doses were scheduled to arrive by the end of the year, however this number was revised down to ‘several million’ during the Downing Street press conference yesterday evening. The remainder are due between January and June 2021, depending on availability - the US and EU regulators are also both likely to approve Pfizer's candidate in the coming weeks.
The Oxford vaccine requires two shots, at least four weeks apart, with protection from approximately 14 days after the second. The UK has pre-ordered 100 million doses and expects 4 million to be available pre-Christmas. The Wrexham lab in which the Oxford vaccines will be manufactured is currently gearing up to produce 150,000 doses per day. It is clear, given the progress of the other candidates, that a phase 1 rollout by April 2021 will depend on the MHRA (a) approving the Oxford vaccine and (b) rollout beginning in the next few weeks.
Key data: the three front-runner vaccines
Pfizer and BioNTech vaccine BNT162b2
Status: Approved by MHRA, December 2nd 2020
What is it and how does it work?: A synthetic mRNA or ‘messenger’ vaccine. Instead of introducing a weakened or dead virus into the body to provoke an immune response, this candidate introduces a ‘messenger’ sequence, constructed from SARS-CoV-2's genetic code and encased in a fat bubble, which essentially uses the body’s own cells as a factory to produce the SARS-CoV-2 spike protein. This then triggers an immune response.
Dosage: two doses, 3 weeks apart ??" protection from 28 days after first inoculation
Trial Data: Over 43000 participants enrolled in the trial worldwide and efficacy was consistent across age, gender, race and ethnicity demographics. 170 Covid-19 cases were confirmed with 162 in the placebo group. Ten of the cases were severe, of which one was in the vaccinated group.
Trial press release can be found here
How many doses has the UK secured access to? 40 million
When will they be available? some before Christmas with the majority expected in the first half of 2021
Manufacturing: Germany and Belgium
Storage: minus 70 degrees centigrade; 5 days at fridge temperature
Cost: £15 / a dose
The University of Oxford AstraZeneca vaccine: ChAdOx1 nCoV-19
Status: MHRA approval pending (data submitted 27th November)
What is it and how does it work? A vector-based vaccine developed using a weakened adenovirus that causes the common cold in chimpanzees. The virus is genetically altered so as to be impossible to grow in humans; 20% of its genetic instructions are then deleted and replaced with instructions from the SARS-CoV-2 spike protein. When the vaccine enters the body, it reproduces the spike protein to mimic a natural infection and provoke an immune response.
Dosage: TBC: either two full doses, at least 4 weeks apart or a half dose followed by a full dose 4 weeks later - protection from 14 days or more after receiving two doses of the vaccine
Efficacy: 62-90% (70% average)
Trial data: Interim data combined from phase 2/3 trials reports 131 Covid-19 cases across 11,636 participants in the UK and Brazil. 30 cases were confirmed in participants who had been vaccinated but there were no hospitalised or severe cases of Covid-19 in any vaccine recipients. Efficacy in the group receiving two full doses was 62% - significantly lower than Pfizer's but potentially high enough for approval (for context, the US regulator's minimum requirement is 50%). Interestingly, approximately a third (2,741) of the UK trial participants, all under the age of 55, were mistakenly administered a half dose in the first instance, followed by a full dose the second time around - a mistake that seems to have resulted in an efficacy of 90% and could be down to a lower initial dose more closely mimicking the progress of a real infection. Confirmatory data is continuing to be gathered.
Trial press release can be found here
How many doses has the UK secured access to? 100 million
When will they be available: if approved, 4 million are expected to be available in December and a further 40 million by the end of March 2021
Manufacturing: capability currently being set up in 10 countries including the UK
Storage: fridge at 2-8 degrees centigrade
Cost: approx. £3 per dose
Moderna and US National Institutes of Health mRNA-1273
Status: phase 3 trial complete
What is it and how does it work? An mRNA vaccine, as described above.
Efficacy: 94% (100% protection against severe disease)
Trial data: Primary analysis of the phase 3 data reports 196 Covid-19 cases in 30,000 US participants. Half were given the vaccine, half the placebo. Of the people who became symptomatically ill with Covid-19, 30 had serious illness and one person died however none of these 30 were in the vaccinated group. Efficacy seems consistent across and, race and ethnicity and gender demographics.
Trial press release can be found here.
How many doses has the UK secured access to? 7 million
When will they be available: spring 2021 at the earliest
Manufacturing: Switzerland and the US
Storage: -20 for up to 6 months; fridge for 30 days
Cost: £25 / dose
Implications for workplace testing: Summary
There is a high risk of post-Christmas virus outbreaks and late winter lockdowns. The initial rollout of the Pfizer vaccine will not change this and some employers are planning start term asymptomatic testing from January in order to mitigate this risk and ensure that they stay operational during the late winter months.
UK tier restrictions and social distancing are unlikely to change before phase 1 of a vaccine rollout is complete which, even assuming the Oxford vaccine is approved, is unlikely to be before April 2021. Given the sheer numbers of people involved, it may well be later.
The majority of private sector working-age people will not be included in either the phase 1 or phase 2 rollouts and it is unlikely that employers seeking private vaccination will be able to access this in the short term.
Most employers requiring testing to remain operational are likely to continue with their programmes until at least April, with a view to extending further into Q2 should delays in rollout occur.
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