New corona vaccine developed by Nuvaxovid Ministry of Health, Labor and Welfare to approve soon

The Ministry of Health, Labor and Welfare has decided to approve the new coronavirus vaccine developed by the American pharmaceutical company Nuvaxovid.

It is a vaccine with a different mechanism from Pfizer and Moderna, and the Ministry of Health, Labor and Welfare expects that it can be inoculated even for people who have allergic reactions, and that stable supply can be expected due to domestic production.

Takeda Pharmaceutical Company Limited, which manufactures and distributes the Novabax vaccine in Japan, applied for approval, and on the 18th, it was approved by the expert committee of the Ministry of Health, Labor and Welfare for people aged 18 and over.

It will be officially approved by the Ministry of Health, Labor and Welfare in the near future, and will be the fourth type in Japan.

According to the Ministry of Health, Labor and Welfare, in clinical trials conducted in the United States and other countries from December to February last year before the epidemic of the Omicron strain began, the effect of preventing the onset was 90.4 about 3 months after the second inoculation. It is reported that it was%.

This vaccine is called a "recombinant protein vaccine" and has a different mechanism from Pfizer and Moderna, and the Ministry of Health, Labor and Welfare envisions that it will be used by people who have allergic reactions to conventional vaccines.

This is the second type of vaccine produced in Japan after AstraZeneca, and the contract is to supply the Japanese government with 150 million doses over the next year.

Of these, 100,000 will be delivered to prefectures in the week of next month 23rd and June 6th, and the Ministry of Health, Labor and Welfare states that "a stable supply can be expected."

What is the vaccine developed by Nuvaxovid?

The new coronavirus vaccine developed by the American pharmaceutical company Novabacs is a type of "recombinant protein vaccine."

Using genetic recombination technology, the protrusions on the surface of the virus artificially create and inoculate a "spiked protein" that serves as a marker when an antibody attacks.

In the "mRNA vaccine" of Physer and Moderna and the "viral vector vaccine" of AstraZeneca, which have been used in Japan so far, the spike protein of the new coronavirus can be produced in the body by administering substances and genes that transmit genetic information. The Novabax vaccine provokes an immune response by administering the artificially made spike protein itself.

Vaccines using this technology have already been put to practical use in vaccines such as "herpes zoster" and "hepatitis B", and are widely inoculated.

From December 2020 to February 2021 in the United States and Mexico, according to data published in the medical journal The New England Journal of Medicine by groups such as Novaxovid and American universities on December 15, 2021. In a clinical study conducted on about 30,000 people aged 18 years and over, 90.4% of the patients were effective in preventing the onset and 100 in the effect of preventing moderate or severe illness after receiving two doses three weeks apart. It was%.

At that time, there were many alpha and beta strains of mutant viruses, but the effect of preventing the onset of these mutant viruses was 92.6%.

Regarding side reactions, 58.0% of those who had some symptoms such as pain at the inoculated site, 78.9% after the second inoculation, and those who had some symptoms other than the inoculated site were the first. It was 47.7% after the inoculation, 69.5% after the second inoculation, malaise was 25.6% after the first inoculation, 49.5% after the second inoculation, 24.9% after the first inoculation, and the second inoculation. Later, 44.5%, muscle pain was 22.7% after the first inoculation, 48.1% after the second inoculation, 0.4% after the first inoculation, 5.7% after the second inoculation, and so on.

All of them often subside in about 1 to 2 days, which is less frequent than the side reactions reported by other new corona vaccines, and no increase in myocarditis or thrombosis was confirmed.

In addition, in a clinical trial conducted in the fall of 2020 in approximately 15,000 people over the age of 18 in the United Kingdom, the effect of preventing the onset was 89.7%, and Nuvaxovid was overall effective even 6 months after inoculation. The sex was 82.7%.

According to Novabax, the vaccine has been conditionally approved for sale by the European Commission and UK regulatory agencies.

On the other hand, in the United States, on January 31, 2022, it was announced that it had applied for an emergency use permit to the FDA = US Food and Drug Administration, but no permit has been issued so far.

If approved in Japan, Takeda Pharmaceutical Company Limited will manufacture and distribute it at its factory in Yamaguchi Prefecture.

Expert "It is meaningful to have more choices"

The vaccine developed by Novabax is a type of vaccine that artificially creates and inoculates the protein of the new coronavirus called "recombinant protein vaccine".

Regarding this type of vaccine, Professor Tetsuo Nakayama of Kitasato University said, "I think there is a sense of security because it is made in the same way as the vaccine that was used before the epidemic of the new coronavirus. A substance called "adjuvant" is added to strengthen the immune response, but the "adjuvant" used in the Novabax vaccine is similar to that used in the herpes zoster vaccine, and what kind of side reaction occurs. To some extent, it can be predicted. It may be considered that systemic side reactions such as fever are slightly lighter than the mRNA vaccine. "

Professor Nakayama pointed out that when the Novabax vaccine is approved, "If many people do not inoculate, the actual effects and side reactions will not be known, and the side reactions after inoculation should be investigated carefully." After that, "It is significant that there are more options besides the mRNA vaccine. Some people hesitate to inoculate the mRNA vaccine due to side reactions such as fever, which may be the reason why the third booster vaccination does not proceed. This vaccine seems to have a little less side reaction than that, so it may be effective for the third inoculation to proceed faster. "