The results of two large studies have shown that the drug is about 90 percent effective. The vaccine will not be supplied to Ukraine.
The European Medicines Agency (EMA), after almost a year of research, on December 20, officially approved the COVID-19 vaccine of the American company Novavax for people over 18 years old. Earlier it was planned to supply this drug to Ukraine from India, but something went wrong. Korrespondent.net tells the details.
Omicron helped
This is the fifth vaccine approved in Europe. The process took longer than expected: a preliminary agreement on the supply of the vaccine Novavax and the EU concluded in December last year, and research began in February. Due to regulatory and operational issues, the procedure dragged on for months. In August alone, a final contract was signed for the supply of up to 200 million doses of the drug.
The rapid spread of the Omicron strain in Europe led countries to impose new restrictions and overcrowded hospitals. So far, four vaccines have been approved in the EU from the manufacturers Pfizer / BioNTech, Moderna, AstraZeneca and J&J. However, faced with rising incidences, the EMA decided to expedite consideration of other drugs and treatments.
Approval of a two-dose vaccine under the Nuvaxovid brand comes earlier than in the US, where the company had to deal with manufacturing problems. Novavax expects to apply for approval by the end of the year.
The vaccine received its first regulatory approval in Indonesia in November, and is pending approval in Japan, where it will be manufactured and distributed by Takeda Pharmaceutical.
In Europe, the final decision on vaccine recognition is made by the European Commission, but its verdict, as a rule, coincides with the opinion of the EMA. Novavax said that the decision of the Commission is expected “in the near future”, writes Reuters.
According to plans, the 27 EU member states will receive the Nuvaxovid vaccine as early as January.
Efficiency and safety
Data from two large studies have shown that the vaccine is about 90% effective. At the same time, the EMA clarified that at present there is no comprehensive information about the effectiveness of the vaccine against the Omicron strain.
“After careful evaluation, the EMA Human Medicines Committee has reached a consensus that the vaccine data is reliable and meets EU criteria for efficacy, safety and quality,” the European regulator said in a statement.
The protein-based Novavax vaccine uses an alternative technology to the other four approved vaccines, making it particularly interesting for the EU as it seeks to diversify its drugs in the midst of the fourth wave of the pandemic.
Earlier research has shown that combining vaccines from different manufacturers can be even more effective than a full course of a single drug. In particular, the introduction of Nuvaxovid after Oxford-AstraZeneca or Pfizer-BioNTech has shown better results than two doses of the same vaccine.
The company has several manufacturing sites, including the Serum Institute of India (SII), the world’s largest vaccine manufacturer. The production of the vaccine at the Indian plant has also been approved by the EMA. At the same time, vaccine antigens, inactivated organisms that trigger an immune response, are produced at the Novavax plant in the Czech Republic.
Novavax does not exclude that at the beginning of 2022 they will develop a vaccine specifically for the Omicron strain. In the meantime, the company is testing how well its current version of the vaccine is working against the new strain.
On December 17, the World Health Organization approved the Covovax vaccine for emergency use, which is manufactured in an Indian plant under license from Novavax.
In October, the company announced that the launch of vaccine production was delayed due to, among other things, a shortage of raw materials, but the problem has been resolved and now it is planned to produce 150 million doses per month by the end of the year, thanks to partnerships with Indian, South Korean and Japanese plants.
It didn’t work out with Ukraine
In May, the previous Minister of Health of Ukraine Maxim Stepanov announced that in the summer Kiev expects the delivery of 10 million contracted doses of Novavax vaccine from the Blood Serum Institute of India, as well as 2 million doses of Covishield vaccine, which is produced at the same plant under license from AstraZeneca.
However, Covishield arrived in the amount of only 500 thousand doses, and the Novavax vaccine did not arrive at all. The new head of the Ministry of Health, Viktor Lyashko, said that he had terminated the contract with the supplier because he had not fulfilled his obligations.
The Novavax vaccine is based on an inactivated virus. It is based on the S-protein of the pathogen SARS-CoV-2, presented in the form of recombinant nanoparticles. The same technology lies at the heart of the Chinese drug Coronavac from Sinovac, which began to vaccinate Ukrainians in May – there were no other vaccines in the public domain. Then the Ukrainian government promised that Europe would soon recognize this vaccine following the WHO, but this has not happened so far.
Protein vaccines are considered “traditional” – they have long been used against influenza, polio, hepatitis, or tetanus. This type is also called “dead” vaccines because they contain inactivated viruses or components of such viruses.
The efficacy of such drugs is slightly lower compared to vector or mRNA vaccines, and their development may take more time. But protein vaccines have a number of advantages: they are well tolerated by the body and do not require ultra-low storage temperatures, which is especially important for the most remote corners of the planet.
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