- Novavax submits data on its Covid vaccine to UK drug regulator
- If approved, it would be the fifth authorized vaccine against the coronavirus
- Britain has ordered 60 million doses and the firm says it expects a ‘positive decision’
Novavax has formally sought regulatory approval for its coronavirus vaccine in the UK.
The US-based firm submitted its final trial data to the drug safety watchdog, in a move that could add another jab to the UK roster.
No10 has already purchased 60 million doses of the jab. But it is not clear how it will be used if approved.
Novavax expects an ‘affirmative decision’ from the Medicines and Healthcare products Regulatory Agency (MHRA).
Its vaccine, officially known as NVX-CoV2373, would be the first protein-based jab approved in the UK, if given the green light.
Novavax’s vaccine, officially known as NVX-CoV2373, will be the first protein-based jab approved in the UK, if given the green light
The government has ordered 60 million doses of Novavax, which the MHRA is currently reviewing. Pfizer is the most ordered jab in the UK, which is expected to reach 135 million Britons by next year. About 100 million doses of AstraZeneca have been ordered, with 60 million doses of the jab being made by GSK. Meanwhile, the government has requested 50 million CureVac vaccines, 20 million Janssen and 17 million Moderna injections. But only four jabs are approved in the UK: AstraZeneca, Pfizer, Moderna and Janssen.
Other injections already approved are either viral vector vaccines made from a common cold virus (AstraZeneca and Janssen), or mRNA vaccines made from enzymes (Pfizer and Moderna).
Everything you need to know about the Novavax COVID-19 vaccine that protects over 90% of people from getting sick
How does the vaccine work?
The Novavax vaccine works like other vaccines by teaching the immune system to make antibodies to the coronavirus spike protein.
The researchers inserted a modified gene into a virus, called a baculovirus, and allowed it to infect insect cells.
The spike proteins from these cells were then assembled into nanoparticles, which look like the coronavirus but cannot replicate or cause Covid-19. These nanoparticles are then injected into the body via the vaccine where the immune system mounts an antibody response.
If the body is faced with the coronavirus in the future, the body is prepared to defend against it. The vaccine is given as two doses.
Are there benefits to the Novavax vaccine?
Yes. While jabs from Pfizer/BioNtech and Modern need to be kept at extremely low temperatures, the Novavax jab is stable in a typical fridge for up to three months.
How effective is the vaccine?
According to the results of Phase III trials, the jab provides 100 percent protection against serious illness, including hospital admission and death.
It is 86 percent effective against the alpha (kent) version and 100 percent effective in preventing cases caused by the original strain of coronavirus.
Is the Novavax Vaccine Approved?
Not now. The UK’s Medicines and Healthcare products regulatory agency is reviewing the data on the jab.
In the US, after Novavax applies for emergency use authorization, the data will be scrutinized by regulators at the Food and Drug Administration.
Novavax contains proteins that mimic the spikes on the coronavirus, producing antibodies to fight the infection. It is given in two doses at an interval of 21 days.
Protein vaccines already in use include hepatitis B and meningitis JABS.
Trials showed that the vaccine was up to 100 percent effective in preventing moderate and severe disease.
The UK has ordered more than 400 million doses of eight differential vaccines, but only four have been approved by the MHRA: AstraZeneca, Pfizer, Moderna and Janssen.
The agency decides whether to approve a vaccine based on safety, quality and effectiveness data.
The submissions from Maryland-based Novavax include data from a phase three clinical trial, which tested the jab on more than 15,000 people in the UK.
it turns out The jab had an efficacy rate of 96.4 against mild, moderate and severe disease caused by the original coronavirus strain.
And it also provided 86.3 percent protection against the alpha strain.
Meanwhile, trials of the vaccine on 30,000 people in the US and Mexico found it provided 100 percent protection against moderate and severe disease.
Trials found the injection to produce a ‘strong’ antibody response, is safe and produces only mild side effects.
Stanley Erck, the company’s President and CEO, said: ‘This submission brings Novavax closer to delivering millions of doses of the first protein-based Covid vaccine, built on a proven, well-understood vaccine platform, Demonstrates high efficacy against many strains. Of coronavirus.
“We look forward to the MHRA review and will be ready to deliver the vaccine dose after what we anticipate will be a positive decision.”
‘We thank the clinical trial participants and trial sites in the UK as well as the UK Vaccine Taskforce for their support and significant contribution to this programme.’
MHRA could not provide any details of its review of the jab due to commercial confidentiality.
Novavax said it plans to submit to regulators in Europe, Canada, Australia and New Zealand “soon” as well as in the US by the end of the year.
Earlier this month, it was announced that 15,000 participants in the UK Novavax trial would have to travel abroad to receive another two doses of the vaccine.
Thousands of volunteers have been unable to travel because other countries do not recognize Novavax as a valid Covid vaccine.