The forgotten Covid jab that might have NO side effects on kids
The Novavax Covid vaccine, which may be just days away from approval in the UK, could be safer for children than the UK’s current jabs, experts say.
It is hoped that the US shot — which uses tried and true vaccine technology and is manufactured in Teeside — could reduce hesitancy and boost uptake in children.
The UK Government already has 60million doses of Novavax on order and trials show it is 96 per cent effective in adults.
But crucially it was shown to cause less side effects compared to those triggered by Pfizer, Moderna or even AstraZeneca‘s vaccines.
The vaccine, known scientifically as NVX-CoV2373, would be the first protein-based jab approved in the UK, if given the green light.
Protein-based jabs are already given to children to protect against the flu, meningitis and hepatitis.
Experts told MailOnline approval of the vaccine could pave the way for the jab being rolled out to children, as well as encouraging the vaccine-hesitant to come forward.
Final study data was submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA) last month and approval is expected in days.
Novavax’s injection, officially known as NVX-CoV2373, would be the first protein-based jab approved in the UK, if given the green light. Protein-based jabs are already given to children to protect against the flu, meningitis and hepatitis
Other injections against Covid already approved in the UK are either viral vector vaccines that are made from a common cold virus (AstraZeneca), or an mRNA vaccine made from enzymes (Pfizer and Moderna).
Novavax’s contains proteins that mimic the spikes on the coronavirus, causing the body to produce antibodies to fight the infection.
If the body encounters coronavirus in the future, the body is primed to fend it off.
The injection is administered in two doses 21 days apart. Unlike the other jabs that need to be stored at ultra-cold temperatures, Novavax can be kept in a normal fridge for up to three months.
EVERYTHING YOU NEED TO KNOW ABOUT THE NOVAVAX COVID VACCINE THAT PREVENTED MORE THAN 90% OF PEOPLE FALLING ILL
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.
Researchers inserted a modified gene into a virus, called a baculovirus, and allowed it to infect insect cells.
Spike proteins from these cells were then assembled into nanoparticles which, while they look like coronavirus, 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 encounters coronavirus in the future, the body is primed to fend it off. The vaccine is given as two doses.
Are there advantages of the Novavax vaccine?
Yes. While the jabs from Pfizer/BioNTech and Moderna need to be kept at ultra-low temperatures, the Novavax jab is stable for up to three months in a normal fridge.
How effective is the vaccine?
According to results of phase III trials, the jab offers 100 percent protection against severe disease, including all hospital admission and death.
It is 86 percent effective against the Alpha (Kent) variant and 100 percent effective in preventing cases caused by the original strain of the coronavirus.
Has the Novavax vaccine been approved?
Not yet. The UK’s Medicines and Healthcare Products Regulatory Agency is reviewing data on the jab.
In the US, the data will be examined by regulators at the Food and Drug Administration after Novavax applies for Emergency Use Authorization.
And phase three by Maryland-based Novavax of more than 15,000 people in the UK found the jab had an efficacy rate of 96.4 against mild, moderate and severe disease caused by the original coronavirus strain.
Meanwhile, a trial of the vaccine on 30,000 people in the US and Mexico found it gave 100 per cent protection against moderate and severe disease.
Protein vaccines already in use include the hepatitis B and meningitis jabs, which are routinely given to newborns.
The vaccines currently used in the UK have saved thousands of lives, while health chiefs said the rollout to children will help keep them in school classrooms.
More than 1million pupils were forced to miss school in a single week in England in July due to the virus.
But one in 10 over-18s in England are yet to have their first dose by November 18.
And uptake among 12 to 15-year-olds was just 38.4 per cent, while 63.9 per cent of 16 to 17-year-olds had had a first dose.
The small risk the virus poses to children, as well as concerns about myocarditis after vaccination, are thought to be factors behind the low uptake.
Data from the Joint Committee on Vaccination and Immunisation shows up to one in 56,000 12 to 15-year-olds will get myocarditis after their first Covid jab.
And the AstraZeneca jab has been linked with blood clots in younger people, which pushed health chiefs to limit the use of the Oxford-made injection to the over-40s.
But Novavax trial data shows the jab only triggered mild and short-lived side effects, with no serious adverse effects.
Its study did not include under-18s and was not big enough to pick up on either of the very rare side effects, but found that adults overall tolerated the jab well, with reported side effects being mild and short-lived.
But experts are hopeful that the findings will hold strong when the jab is rolled out in the population.
Professor Neil Mabbott, chair in immunopathology at the University of Edinburgh, told MailOnlinethe because the jab has fewer side effects than the current crop of injections used in the UK, Novavax ‘could offer an alternative strategy for use in children that might avoid the very low risk of developing potentially severe side effects’.
And similar protein-based technology has been used for years in routine childhood vaccines, he said.
Professor Mabbott said: ‘This may help to provide some safety reassurance to those who until now have been hesitant about coming forward to have their own Covid vaccine.
‘This may also help to alleviate the concerns parents may have about the use of these vaccines in children. This could have a positive impact on vaccine uptake.’
He added: ‘It is important to mention that serious side-effects such as blood clots and heart inflammation following vaccination with the mRNA-based (Pfizer or Moderna) and adenovirus-based (AstraZeneca or Janssen) Covid vaccines have been very rare.
The UK has ordered 60million doses of the Novavax vaccine. In total, Britain has ordered more than 400million doses of eight difference vaccines, but only four have so far been approved by the MHRA: AstraZeneca, Pfizer, Moderna and Janssen
‘Use of these vaccines in protecting against serious disease or death following coronavirus infection continues to outweigh the very low risk of side effects.’
But he noted that an approval of the Novavax vaccine ‘could have a positive impact on vaccine uptake by encouraging as many people as possible to be fully vaccinated against the coronavirus’.
The MHRA decides whether to approve any vaccine based on safety, quality and effectiveness data.
The agency said it could not advise when it expects to issue a decision due to commercial confidentiality.
Dr Michael Head, a senior research fellow in global health at the University of Southampton, told MailOnline: ‘A new vaccine approval will be excellent news.
‘The data publicly available on Novavax looks very promising, both in terms of effectiveness, but importantly also with safety.
‘The existing COVID-19 vaccines are excellent. However, if extra people can be persuaded to become vaccinated because Novavax is a ‘tried and tested’ approach to vaccine development, then that can only be a good thing.’
Dr Alexander Edwards, an associate professor in biomedical technology at the University of Reading, told MailOnline the Novavax vaccine is ‘tremendously exciting’ because it’s made differently to the other Covid jabs used in the UK and contains very different ingredients.
He said: ‘The more different tools we have to reduce the harm caused by Covid, the better.
‘All of the vaccines stimulate antibody responses that effectively neutralise the virus, stopping it growing in our bodies- and the most important benefit of this is a really impressive reduction in the risk of severe disease.
‘But also it helps slow the spread, so getting vaccinated protects you but also helps others.’