Pfizer and BioNTech’s mRNA-based COVID-19 vaccine has been granted authorisation for emergency use in the UK, making it the first nation to approve the novel vaccine.

The vaccine’s path through conceptualisation, development and approval has advanced at an unprecedented rate, taking only ten months.

Typically, in non-pandemic situations, it takes years for a potential vaccine to move from the development stages toward authorisation, with the current COVID-19 vaccine timelines reflecting the urgency involved in finding an effective vaccine.

Following approval from the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA), the Pfizer/BioNTech vaccine will be available from next week, said Health Secretary Matt Hancock.

The approval closely follows final analysis of the vaccine, BNT162b2, which found that it has an efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective).

The company added that the efficacy rate was consistent across age, gender, race and ethnicity, with the observed efficacy in adults over 65 years of age coming in at over 94%.
The UK has already signed a supply deal for 40 million doses of BNT162b2, with the first of these set to be delivered ‘immediately’.

BNT162b2 is being manufactured in Belgium, among other locations, although this particular Pfizer manufacturing site is ‘critical to distribution in the UK’.

The vaccine will be rolled-out to priority groups first, with care home residents, health and care staff and the elderly slated to become the first to be offered the shot.

“The vaccine will be made available across the UK from next week. The NHS has decades of experience in delivering large-scale vaccination programmes and will begin putting its extensive preparations into action to provide care and support to all those eligible for vaccination,” commented a Department of Health and Social Care spokesperson.

According to the BBC, approximately 50 hospitals are prepared to administer the vaccine, while vaccination centres are also currently getting ready to roll-out BNT162b2.

BNT162b2 has a recommended storage temperature of minus 70˚C (minus 94°F), which is well below the typical vaccine storage temperature of +2˚C to +8˚C. This means it will likely be easier to administer the vaccine in a hospital setting, rather in the community.

Pfizer/BioNTech have developed novel temperature-controlled shipping containers, which they say can maintain this temperature for ‘extended periods of time’. The companies added, however, that once the vaccine vial has thawed, the vial can also be stored for up to five days at typical refrigerated conditions.

A US Food and Drug Administration (FDA) expert panel is due to meet on 10 December to discuss BNT162b2, and Pfizer/BioNTech has also submitted the vaccine to the European Medicines Agency (EMA) for emergency approval.

“Today’s emergency use authorisation in the UK marks a historic moment in the fight against COVID-19. This authorisation is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the UK,” said Albert Bourla, chairman and chief executive officer of Pfizer.

AstraZeneca (AZ) has announced that its Oxford University-partnered COVID-19 vaccine candidate AZD1222 has an average efficacy of 70%, according to an interim analysis of trials in the UK and Brazil.

The efficacy rate comes from a combined analysis of two dosing regimens of AZD1222. One dosing regimen demonstrated a vaccine efficacy rate of 90%, when the shot was given as a half dose and followed by a full dose at least one month apart.

A second dosing regimen, however, showed 62% efficacy when given as two full doses at least one month apart.

The interim analysis was based on 131 COVID-19 cases among participants who either received the AZD1222 vaccine or a comparator meningococcal conjugate vaccine.

Although the current AZ results look less promising in comparison to the efficacy rates observed for Pfizer/BioNTech and Moderna’s candidate, AZD1222 has other benefits – including a low cost and easy storage requirements.

The vaccine can be stored, transported and handled at normal refrigerated conditions for at least six months, while Pfizer/BioNTech and Moderna’s vaccines need to be stored at far lower temperatures.

According to the BBC, AZ’s vaccine is also priced much lower, coming in at around £3 while Pfizer/BioNTech’s is reportedly priced at around £15 and Moderna’s around £25.

Moderna is seeking regulatory approval in the US and the EU for its COVID-19 vaccine candidate after posting an updated primary efficacy analysis for the vaccine of 94.1%.

In November, Moderna announced initial data from an interim analysis of its phase 3 COVE study which suggested that its COVID-19 vaccine, mRNA-1273, is 94.5% effective.

The preliminary data was based on analysis of 95 confirmed COVID-19 cases within the study – 90 of which occurred in the placebo group and five within the vaccinated arm.

The updated data analysis is based on 196 cases, of which 185 cases of COVID-19 were observed in the placebo group versus 11 cases in the mRNA-1273 group, reflecting a point estimate vaccine efficacy of 94.1%.

In addition, an analysis of severe cases of COVID-19 within the study found 30 severe cases – all of these cases occurred in the placebo group, with none observed in the mRNA-1273 vaccinated group.

“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease,” said Stéphane Bancel, chief executive officer of Moderna.

Following the new, positive data analysis, Moderna also announced that it has submitted an emergency use authorisation (EUA) application to the US Food and Drug Administration (FDA) for mRNA-1273.

An FDA panel of outside experts – the Vaccines and Related Biological Products Advisory Committee (VRBPAC) – is due to review the safety and efficacy data for mRNA-1273 on 17 December, Moderna added in a statement.

The company is also set to apply for a Conditional Marketing Authorisation (CMA) application with the European Medicines Agency (EMA), priming itself to score regulatory approval for the vaccine on both sides of the Atlantic.