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Novavax will be approved as the fourth Covid vaccine in the UK | Vaccines and immunization

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Pfizer, AstraZeneca, Moderna. The British are so accustomed to the three Covid vaccines available in the UK that most, despite the government ordering 60 million doses and hundreds of UK jobs relying on it. One forgets another jab, Nova Bucks.

At the end of last month, a US company with a factory ready to manufacture doses in Teesside submitted final data to UK regulators, and a positive decision is expected within days or weeks. It will end what feels like a long wait compared to the rapid development and approval of other jabs, including those who participated in the exam.

So how does this additional weapon make a difference to British vaccination weapons? Novavax’s products are protein-based jabs similar to those used for influenza protection and regular childhood vaccination against whooping cough and meningococcal infections.

Other protein-based Covid vaccines, including those developed by Sanofi and GSK, are in late-stage clinical trials with 60 million orders from the UK. The final data for Phase 3 trials are expected someday, paving the way for companies to seek regulatory approval.

The existing UKCovid-19 jab directs cells to produce the coronavirus spike protein, but protein-based vaccines pre-prepare and provide a fragment of it along with an immunostimulatory adjuvant.

In clinical trials, two doses of Novavax jab About 90% effectiveness Against Symptomatic Covid – Similar to other approved UK vaccines. He has also been “mixed and matched” with Oxford / AstraZeneca or Pfizer / BioNTech jabs. Preliminary data It suggests that it produces a strong immune response when given as a second dose.

But what can make Novavax particularly attractive are new signs of reduced side effects.

Test data appear to indicate that it may be less “reactive” than existing jabs. This means that side effects such as swelling at the injection site, malaise, headache, and muscle aches are less likely to occur. However, direct direct comparisons have not yet been made and further investigation is needed.

“For example, infants are very unlikely to be infected with severe Covid-19, so reduced responsiveness is especially important in groups such as children who have a slightly uncertain balance between vaccination and non-vaccination. “. Professor Paul Heath, director of the Vaccine Research Institute at the University of London, St. Georges, and senior researcher at Novabax’s UK study.

However, the caveat with the new vaccine is that rare side effects may not be apparent until the vaccine is widely used, said Azeem Majeed, a professor of primary care and public health at Imperial College London. .. “Post-marketing surveillance is needed to identify previously unknown side effects,” he said.

The fact that it uses more established vaccine technology can also make it more attractive. Heath said: “People who were hesitant to get other Covid vaccines may be more likely to accept vaccinations using this protein adjuvant technology. It may be more familiar to them, so please be happy to receive it. prize.”

Majeed is not convinced that Novavax will make a big difference in intake, but there are other benefits to such protein-based vaccines. It is easier to transport and store than mRNA-based vaccines because it can be stored in a standard vaccine refrigerator at 2 ° C to 8 ° C. He states: “The AstraZeneca vaccine has similar storage requirements as Novabax, but the UK government seems to have significantly stopped its use.”

Access to a wider range of vaccines will also help if regular boosters are needed in the future. “Novavax’s simple storage requirements make it easier for general practitioners and pharmacies to use,” says Majeed.

This combination of ease of transport and storage is even more important in developing countries where cold controlled supply chains are not well established. Brendan Wren, a professor of microbial pathogenesis at the London School of Economics and Tropical Medicine, said:..

Work may also come with a new jab. In March, Boris Johnson announced a dose of 60 meters in northeastern England. Fujifilm Diosynth manufactures them at the Billingham factory, GSK fills them, finishes them, puts them in vials, Barnard Castle..

It is said that about 300 people are working on vaccines at Fujifilm, but there was concern that delays could hinder their work. Fujifilm said last month that the manufacturing industry was unaffected by the delay and plans to increase its workforce over the next few years.

Alex Cunningham, a local Labor lawmaker on behalf of Stockton North, said he was relieved to meet with a representative of Novabax. “I don’t know how long the approval process will take, but I hope the production environment is up and running soon,” he said.

Novavax Jab has already been approved for use in the Philippines and Indonesia. On November 4, the company submitted an emergency use application to the world. health Organization. If approved, it will be the first protein-based vaccine recommended by WHO.

Novavax told The Guardian that it now routinely produces high-quality products on a commercial scale at multiple sites around the world.The Serum Institute of India also manufactures production doses, of which 20m Export approved To Indonesia.

Silvia Taylor, Senior Vice President of Global Corporate Communications and Investor Public Relations at Novavax, said: [to the UK Medicine and Healthcare products Regulatory Authority] Has completed. The timeline is in the hands of regulators. “

Sources

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2/ https://www.theguardian.com/society/2021/nov/24/novavax-expected-to-be-approved-as-fourth-covid-vaccine-in-uk

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