The UK has become the first country to authorise a COVID-19 vaccine and will begin vaccinations next week, after the government’s independent scientific advisory body, the Medicines and Healthcare products Regulatory Agency (MHRA), granted temporary authorisation for emergency use for Pfizer-BioNTech’s mRNA vaccine (BNT162b2).
MHRA announced the news yesterday after starting a “rolling review” in October of all available data on BNT162b2 — i.e. laboratory pre-clinical studies, clinical trials, manufacturing and quality controls, product sampling, testing of the final vaccine, and conditions for its safe supply and distribution — and after Pfizer and BioNTech confirmed on November 18 that final efficacy analysis of its phase 3 study demonstrated 95% efficacy and met all of the study’s primary endpoints.
- Primary efficacy analysis demonstrates BNT162b2 is 95% effective against COVID-19 beginning 28 days after the first dose; 170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus eight in the vaccine group.
- Efficacy was consistent across age, gender, race and ethnicity demographics; observed efficacy in adults over 65 years of age was more than 94%.
- Safety data milestone required by US Food and Drug Administration (FDA) for emergency use authorisation (EUA) has been achieved. Data demonstrate the vaccine was well tolerated across all populations, with more than 43,000 participants enrolled; no serious safety concerns were observed; the only grade three adverse event greater than 2% in frequency was fatigue, at 3.8%, and headache, at 2.0%.
Pfizer and BioNTech have an agreement to supply the UK with a total of 40 million doses — enough for 20 million, as two jabs are required for immunisation — and are expecting emergency use authorisation decisions from American and European regulators within weeks.
Moderna, with its mRNA-based candidate that formally achieved 94%.1 efficacy this week, has also sought EUAs in the UK, US and Europe.
The British government has formally asked MHRA to assess AstraZeneca-Oxford’s protein-based candidate — which demonstrated 70-90% efficacy but is both cheaper to produce and only requires refrigeration rather than extremely low temperatures for storage — temporary supply.
How will the vaccine be distributed?
According to The Guardian, UK health secretary Matt Hancock said the country will have 800,000 doses available next week.
Hancock also said a network of 50 hospitals capable of keeping the drug at -70C is ready to deliver the first jabs, while specialist vaccination centres are being built.
Some GPs and pharmacists with cold storage facilities will also be used.
Distribution will then be prioritised according to the populations identified in new guidance from the Joint Committee on Vaccination and Immunisation, which advises that the first priorities for any vaccination program should be the “prevention of COVID-19 mortality and the protection of health and social care staff and systems”.
Secondary priorities could include vaccination of those at increased risk of hospitalisation and at increased risk of exposure, and to maintain resilience in essential public services.
The committee also notes that as there is no data as yet on the safety of COVID-19 vaccines in pregnancy, either from human or animal studies, “JCVI favours a precautionary approach, and does not currently advise COVID-19 vaccination in pregnancy.”
The order of priority for phase 1 corresponds with data on the number of individuals who would need to be vaccinated to prevent one death, estimated from UK data obtained from March to June 2020:
- Residents in a care home for older adults and their carers;
- All those 80 years of age and over, plus frontline health and social care workers;
- All those 75 years of age and over;
- All those 70 years of age and over, plus clinically extremely vulnerable individuals;
- All those 65 years of age and over;
- All individuals aged 16 years to 64 years with underlying health conditions that put them at higher risk of serious disease and mortality;
- All those 60 years of age and over;
- All those 55 years of age and over; and
- All those 50 years of age and over.
On the second phase, the committee believes the key focus for the second phase of vaccination could be on further preventing hospitalisation, as well as those at increased risk of exposure due to their occupation — first responders, the military, people involved in the justice system, teachers, transport workers, and public servants essential to the pandemic response.
Limits of approval and Australia’s timeline
Last night, the Therapeutic Goods Administration issued a statement emphasising that the UK emergency use authorisation is temporary and “only relates to a limited number of specific batches of the COVID-19 vaccine BNT162b2 supplied by Pfizer and BioNTech, in response to the increased spread of COVID-19 and loss of life”.
“This emergency approval is not a market authorisation, therefore there is no general authorisation to place this vaccine on the market in the UK,” the statement reads.
“This emergency authorisation is in response to the very high disease load in the UK at present, noting that sadly the UK has had over 13,400 new COVID cases in the last 24 hours (Dec 1, 2020) and has had over 59,000 deaths.”
“It allows the UK Government to deploy the vaccine as quickly as possible to specific groups of patients such as frontline healthcare workers, people over 80 and aged care residents. It is understood that under the emergency use authorisation the vaccine will not be generally available to the wider UK population.”
Health Minister Greg Hunt has welcomed the news and noted that Pfizer continues to work with the TGA and the government’s advice “remains that the timeline for a decision on approval is expected by the end of January 2021, and our planning is for the first vaccine delivery in March 2021”.
This article was first published by The Mandarin.