UK’s MHRA Approves Moderna’s COVID-19 Vaccine, Eyes 10M Additional Doses to Roll-out From Spring

Date: January 8, 2021 | Country: UNITED KINGDOM | Region: EUROPE | Type: Drug Approval | Keywords: #approval #biontech #covid-19 #mhra #moderna #mrna #pfizer #sars #uk #vaccine

PRICENTRIC BRIEF:

  • The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved its third COVID-19 vaccine for use, Moderna’s messenger RNA (mRNA) shot
  • The government is also looking to order an additional 10 million doses, bringing the total pre-purchase amount to 17 million from Moderna, so that the vaccine can ideally be rolled out from March
  • The vaccine will join the ranks of the Pfizer/BioNTech and AstraZeneca (AZ) jabs, which have both already been approved by the UK drug regulator

THE DETAILS

LONDON, United Kingdom – The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved its third COVID-19 vaccine for use, Moderna’s messenger RNA (mRNA) shot.

The government is also looking to order an additional 10 million doses, bringing the total pre-purchase amount to 17 million from Moderna, so that the vaccine can ideally be rolled out from March.

The decision is based on clinical trial evidence that demonstrated that the vaccine was effective in preventing COVID-19 in people aged 18 years and older, showing a 94.1% reduction in the number of symptomatic COVID-19 cases in people who received the vaccine versus those who received dummy injections, meaning the vaccine has a 94.1% efficacy rate.

The vaccine will join the ranks of the Pfizer/BioNTech and AstraZeneca (AZ) jabs, which have both already been approved by the UK drug regulator.

On the announcement, Health Secretary Matt Hancock noted: “This is further great news and another weapon in our arsenal to tame this awful disease.

“We have already vaccinated nearly 1.5 million people across the UK and Moderna’s vaccine will allow us to accelerate our vaccination program even further once doses become available from the spring.

“While we immunize those most at risk from Covid, I urge everyone to continue following the rules to keep cases low to protect our loved ones.”

UK Dosing Schedules

According to the Company, the Moderna shots should be administered in two injections, 28 days apart. The UK is already having dosing schedule problems with its two previously approved vaccines, as the AZ shot needs two doses to be considered fully effective, with an interval of between four and 12 weeks. The first dose was rolled out from Monday 4 January 2021, and follow-up appointments will be booked in the coming weeks.

Pfizer’s second shot is ideally administered within a 21-day period, but the UK’s currently implemented dosing schedule means that some second doses could be administered as many as 12 weeks later, in an effort to vaccinate as many at-risk people as possible with the first shot.

As such, Public Health England’s head of immunizations, Mary Ramsay, recently defended the UK’s decision to administer the second dose of a different vaccine on “extremely rare occasions.”

She noted, “Every effort should be made to give them the same vaccine, but where this is not possible it is better to give a second dose of another vaccine than not at all.”

Roll-out Logistics

The Moderna vaccination, despite being based on mRNA technology like Pfizer’s, only needs to be stored in refrigerated conditions between 2°C and 8°C (36°F and 46°F) for up to 30 days before the vials are punctured for use. This is much more convenient than the -70C and -80C conditions that Pfizer’s shots require all the way from the production facility to the patient.

AstraZeneca’s candidate is overall more convenient than its two competitors which has ultimately given it a boost when it comes to production and distribution, as the vaccine can also be stored, transported and handled at normal refrigerated conditions (2-8 degrees Celsius/ 36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.

Both of the other two frontrunners are based on mRNA technology and have to be stored in specific settings, but Moderna has the edge over Pfizer in the sense that its candidate can be stored at standard refrigeration temperatures of 2C to 8C for 30 days, whereas Pfizer’s efforts must be stored between -70C and -80C all the way from the production facility to the patient.

*Based on U.S. price, converted from USD as UK price has not been officially disclosed

The national health service (NHS) has also announced that the AZ shots will be available at GP services, to help protect care home residents and other vulnerable people against COVID-19.

The government recently named seven sites in England that will be turned into mass vaccination centers:

  • Robertson House in Stevenage
  • ExCel Centre in London
  • Centre for Life in Newcastle
  • Etihad Tennis Centre in Manchester
  • Epsom Downs Racecourse in Surrey
  • Ashton Gate Stadium in Bristol
  • Millennium Point in Birmingham

The pop-up centers are all part of Boris Johnson’s bid to vaccinate up to 14 million people in England by mid-February.

Trailing the European Union

The MHRA is now the UK’s standalone medicines and medical devices regulator as of 1 January 2021, due to Brexit, so it’s promising news that the UK approval is hot on the heels of the European Commission’s conditional marketing authorization (CMA), as it demonstrates that the MHRA is off to a strong start in its independence.

The official EU authorization followed a recommendation from the European Medicines Agency (EMA) based on the same clinical trial evidence that showed Moderna’s vaccine effort was effective in preventing COVID-19 in people aged 18 years and older.

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