The first person in the world was given AstraZeneca and Oxford University’s COVID-19 vaccine on 4 January in the UK, less than a week after the vaccine was approved by the Medicines and Healthcare products Regulatory Agency (MHRA).

Brian Pinker, an 82-year-old dialysis patient, received the AZ/Oxford University vaccine at the Churchill Hospital, which is managed by the Oxford University Hospitals NHS Foundation Trust.

Over half a million doses – approximately 530,000 – of the vaccine were due to be made available in the first full week of January, with further doses set to become available over the coming weeks and months. The vaccine doses will be administered 12 weeks apart, rather than the original 21-day gap, as the UK government aims to speed up its vaccination roll-out plans.

The aim of the 12-week gap is to allow more people to receive their first dose, with the UK’s chief medical officers maintaining that “the great majority of the initial protection from clinical disease is after the first dose of vaccine”.

The AZ/Oxford University COVID-19 vaccine is the second one to be approved in the UK, after Pfizer/BioNTech’s vaccine was authorised in December.

In comparison to Pfizer/BioNTech’s vaccine, which must be stored at -70°C, AZ/Oxford University’s vaccine can be stored at standard refrigerator temperatures of between +2°C to +8°C.

The Department of Health and Social Care (DHSC) also announced that over a million people in the UK have already been vaccinated with the Pfizer/BioNTech vaccine.
It added that the AZ/Oxford University vaccine will be ‘easier to distribute to care homes and other locations across the UK’, thanks to its standard storage temperature.

Just days before Christmas, the European Commission granted Pfizer/BioNTech’s COVID-19 vaccine a conditional market authorisation (CMA).

On the same day, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion of the vaccine.
After reviewing the available data, the CHMP adopted a positive opinion of the vaccine, which will now be market as Comirnaty in the EU following the EC authorisation.

The vaccine is indicated for active immunisation to prevent COVID-19, caused by the SARS-CoV-2 virus, in individuals aged 16 years and older, in line with US and UK regulators.

“As a company founded and headquartered in the heart of Europe, we are looking forward to delivering the vaccine to Europeans in the coming days. We believe that vaccinations may help reduce the number of people in high-risk populations being hospitalised. Moving forward, we will continue to collect efficacy and safety data in participants for an additional two years and test the vaccine against additional mutations that might occur,” said Ugur Sahin, chief executive officer and co-founder of BioNTech.

In November 2020, the EC signed a contract with Pfizer/BioNTech for the initial purchase of 200 million doses on behalf of all EU member states. This includes an option to secure an additional 100 million doses, set to be supplied when the vaccine has been proven to be ‘safe and effective’ against COVID-19.

As part of that contract, EU member states can donate doses of the vaccine to lower and middle-income countries or redirect them to other EU countries.

Under the CMA process, the companies will also be required to continue to provide results from the main phase 3 trial of their vaccine, which will continue for two years.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance, warning people with a history of allergic reactions not to have the Pfizer/BioNTech COVID-19 vaccine.

The UK began administering the vaccine, BNT162b2, in December 2020 after the MHRA gave the vaccine a green light for emergency use.

Since then, the MHRA has received two reports of anaphylaxis – severe allergic reactions – and one report of a possible allergic reaction following immunisation with the Pfizer/BioNTech vaccine.

The individuals who experienced the reactions recovered after receiving ‘prompt’ treatment, said the MHRA.

The MHRA now recommends that anyone with a history of anaphylaxis, whether as a reaction to a vaccine, medicine or food, should not have the recently approved vaccine.
In addition, people who have experienced anaphylaxis after receiving the first dose of BNT162b2 should not be given a second dose.

The MHRA added that those who are due to receive the vaccine should still continue with their appointments and discuss any concerns or their medical history with a healthcare professional prior to receiving the vaccine.

Anaphylaxis is a very rare side effect of vaccines, the MHRA added in a statement.

Last month, the FDA announced that the Pfizer/BioNTech coronavirus vaccine, which offers up to 95% protection against COVID-19, is safe and effective.

The Pfizer/BioNTech vaccine has already been approved for emergency use in four other countries: the UK, Canada, Bahrain and Saudi Arabia. The US will follow these countries in giving the vaccine to the elderly and health workers first.

“The FDA’s authorisation for emergency use of the first Covid-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said Stephen Hahn, head of the FDA.

Hahn emphasised that the review process had been “open and transparent” and that authorisation was given only after the FDA had ascertained that the vaccine met the agency’s “rigorous, scientific standards for safety, effectiveness and manufacturing quality”.

On 10 December 2020, a US FDA advisory committee panel recommended Pfizer/BioNTech’s COVID-19 vaccine for emergency use, after voting that the vaccine’s benefits outweighed its risks.

Pfizer will need to file a separate application to receive full approval for the vaccine, as full approval is not included as part of the emergency use approval.

Just days before Christmas, Moderna’s mRNA-1273 became the second
COVID-19 vaccine to be granted a US Food and Drug Administration (FDA) emergency use authorisation (EUA), on the heels of Pfizer/BioNTech’s BNT162b2 vaccine.

The FDA issued the EUA shortly after its Vaccines and Related Biological Products Advisory Committee voted in favour of authorising the vaccine for emergency use.
Results from Moderna’s primary efficacy analysis of 196 cases in the phase 3 trial of the COVID-19 vaccine reflected a 94.5% efficacy rate.

The committee voted 20-0 with one abstention that the benefits of the mRNA-1273 vaccine outweighed the risks in individuals aged 18 years and over.

Following this recommendation, the FDA has formally granted mRNA-1273 a EUA for the prevention of COVID-19 in individuals aged 18 years and older.

Pfizer/BioNTech’s vaccine followed a similar path, with its EUA coming only a day after it received expert panel backing.

While Moderna’s vaccine can be administered to adults aged 18 years and over, Pfizer/BioNTech’s vaccine has a slightly different authorisation, for use in individuals aged 16 years and older.

The use of Pfizer/BioNTech’s vaccine in this younger age group was a slight point of contention during the expert panel’s discussions, but ultimately the committee voted 17-4 that the benefits of the vaccine outweigh the risks for immunisation in people aged 16 years and older.

“I am proud of what the Moderna team has achieved in collaboration with our partners. We were able to create and manufacture the Moderna COVID-19 vaccine in 11 months from sequence to authorisation, while advancing clinical development with a phase 1, phase 2 and pivotal phase 3 study of 30,000 participants,” said Stéphane Bancel, chief executive officer of Moderna.

The World Health Organization (WHO) has given Pfizer/BioNTech’s COVID-19 vaccine emergency use validation after reviewing data from both companies.

The Pfizer/BioNTech vaccine is the first to receive emergency validation from WHO since the outbreak began, after Pfizer/BioNTech received their first emergency use authorisation (EUA) for a COVID-19 vaccine from the UK’s MHRA.

The UK regulatory approval and WHO’s emergency use listing (EUL) approval are based on data from a final analysis of the Comirnaty COVID-19 mRNA vaccine.

In a news release on 31 December 2020, WHO stated: ‘Regulatory experts convened by WHO from around the world and WHO’s own teams reviewed the data on the Pfizer/BioNTech vaccine’s safety, efficacy and quality as part of a risk-versus-benefit analysis. The review found that the vaccine met the must-have criteria for safety and efficacy set out by WHO, and that the benefits of using the vaccine to address COVID-19 offset potential risks.’

The EUL enables UNICEF and the Pan-American Health Organization to procure the vaccine for distribution to countries in need.

“This is a very positive step towards ensuring global access to COVID-19 vaccines. But I want to emphasize the need for an even greater global effort to achieve enough vaccine supply to meet the needs of priority populations everywhere,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products.