Novavax has sought regulatory approval for its coronavirus vaccination in Britain.
The US-based company submitted its final trial results to drug safety watchdogs. This could mean that another jab is added to the UK’s arsenal.
60million jabs have already been purchased by No10. It is not yet clear how the jab would be used if it is approved.
Novavax is expecting a positive decision by the Medicines and Healthcare products Regulatory Agency, (MHRA).
If granted the green light, its vaccine, officially known by NVXCoV2373, will be the first protein-based jab to be approved in the UK.
Novavax’s vaccine, formally known as NVXCoV237373, would be the first approved protein-based jab in the UK if it was given the green light
The 60 million Novavax doses ordered by the Government are currently being reviewed by the MHRA. Pfizer is the UK’s most popular jab. 135 million are expected to arrive in Britain by next Year. AstraZeneca has been ordered in 100 million doses, with 60 million doses from GSK. The Government has also requested 50million CureVac vaccines and 20million Janssen injections. Only four jabs were approved in the UK: Janssen, Moderna, Pfizer and AstraZeneca
Other injections approved include viral vector vaccines containing a common cold virus (AstraZeneca, Janssen) and an mRNA vaccine containing enzymes (Pfizer & Moderna).
Novavax contains proteins that are similar to the coronavirus spikes, which causes Novavax to produce antibodies to fight the infection. It is administered in two doses, 21 days apart.
Protein vaccines already in use include the hepatitis B and meningitis jabs.
Trials revealed that the vaccine was effective in stopping severe and moderate disease.
The UK has ordered over 400 million doses of eight different vaccines. However, only four have been approved so far by the MHRA: Janssen, Moderna, Pfizer and Moderna.
The agency makes the final decision on whether to approve a vaccine based upon safety, quality, and effectiveness data.
Novavax, Maryland-based, submitted data from the Phase Three Clinical Trial. This trial tested the jab in more than 15,000 people in Britain.
It was revealed the jab had an efficacy rate of 96.4 against mild, moderate and severe disease caused by the original coronavirus strain.
It also provided 86.3 per cent protection against the Alpha strain.
A trial of the vaccine in the US and Mexico on 30,000 people found that it provided 100 percent protection against moderate and severe diseases.
The injection was safe, produced a robust antibody response and caused only mild side effects in clinical trials.
Stanley Erck is the company’s president, chief executive officer, and said that Novavax is now closer than ever to delivering millions of doses. The submission was based on a well-understood vaccine system that has shown high efficacy against multiple strains.
“We look forward the MHRA’s review, and will be ready to deliver vaccine dosages following what will be a positive outcome.”
“We thank all the UK Vaccines Taskforce as well as clinical trial participants and sites in the UK for their support and vital contributions to this program.”
Due to commercial confidentiality, MHRA could not give any details about its review.
Novavax stated that it will submit its jab to regulators in Europe and Canada, Australia, New Zealand, Australia, and New Zealand “shortly” as well as to the US by year’s end.
An announcement was made earlier this month that the 15,000 Novavax trial participants in the UK would have to receive two doses of another vaccine for travel abroad.
Because Novavax is not recognized as a valid Covid vaccine in other countries, thousands of volunteers have been unable or unwilling to travel.