Focus on the possibility of NovaVax vaccine booster shot

Experts attending the meeting said that the majority of the people should consider the existing vaccinations

The basic vaccination permission comes first, and additional vaccinations will be reviewed later by the quarantine authorities

More suitable for unvaccinated people, and the immune response is higher than that of the virus vector.

Experts expressed great interest in the cross-vaccination use of the vaccine during the Novavax COVID-19 vaccine screening process approved in Korea on the 12th of last month.

 

This is because Novavax is likely to be used for additional vaccinations, so-called booster shots, in a situation where most people have been vaccinated with different types of vaccines.

 

However, the MFDS said that among the clinical data submitted by the company, there is a lack of valid data for cross-vaccination, and that cross-vaccination can be considered only when basic vaccination permission is given priority.

 

Such information is recorded in the minutes of the Central Pharmaceutical Affairs Council released on the website of the MFDS on the 7th.

 

Novavax was approved in Korea under the product name Nuvaxovid PFS on the 12th of last month.

 

SK Bioscience receives technology transfer from Novavax and manufactures the vaccine from the undiluted solution to the finished product.

 

It is the first gene recombination vaccine licensed in Korea, and is the fifth approved COVID-19 vaccine after AstraZeneca, Janssen, Pfizer, and Moderna.

 

After the MFDS' self-examination, it was finally approved through a verification advisory group composed of experts, the Central Pharmaceutical Affairs Council, and the final inspection committee.

 

Among them, the Central Pharmaceutical Affairs Council has the greatest impact on vaccine licensing.

 

Fifteen external experts and eight officials from the MFDS attended the Central Pharmaceutical Affairs Council meeting held at 2 p.m.

 

on the 6th of last month in the headquarters of the MFDS in Osong.

 

Experts who attended that day asked about the evaluation of related efficacy, saying that the Novavax is likely to be used for additional vaccinations (booster shots) with the majority of Koreans receiving the existing vaccine.

 

The MFDS said, "The difference between this applied vaccine and the existing one is a single-use PFS, and if it is not used within the deadline after opening as a multi-use vial, it should be discarded." The MFDS also said, "It is also advantageous in terms of compliance with administration as a vaccine for gene recombination platforms that have already been commercialized." Since the company announced plans to develop adolescents and additional vaccinations, the MFDS expressed expectations for youth use with low vaccination rates.

 

In response, a member of the committee asked, "Is there any study conducted as an additional vaccination for vaccines on other platforms in foreign countries?" and the MFDS replied, "According to data released in the UK, additional vaccinations were made for companies D and B." The MFDS explained, "When additional vaccinations were given to those who completed the basic vaccination of Company D, they showed a higher immune response than those who received the virus vector vaccine." However, the MFDS said, "After deciding whether the safety and effectiveness of the applied vaccine can be recognized in terms of permission, the quarantine authorities will decide whether to use it by reflecting the current situation." The MFDS also stressed, "Additional vaccinations can be reviewed only when permission for basic vaccinations is decided first." Nevertheless, at the meeting, some suggested that an additional phrase "need to check cross-vaccination data later" is needed for Novavax permits.

 

The MFDS replied, "In some cases, normal cross-vaccinations can be confirmed through the published results of other research institutes such as universities, and it is difficult for the company to submit all of them." As a result, the committee agreed to approve the Novavax as "for use twice every three weeks for those aged 18 or older," but did not conclude separately regarding cross-vaccination.

 

Meanwhile, the Novavax is expected to begin vaccination for unvaccinated patients at each hospital and clinic soon after approval from the MFDS.