Entered the approval review stage for single inoculation
As global pharmaceutical companies compete to develop a respiratory syncytial virus (RSV) vaccine, attention is focusing on whether new RSV preventive vaccines will be released this year.
According to related industries on the 14th, Pfizer, GSK, Sanofi, AstraZeneca, and Moderna are fiercely competing to develop vaccines and antibody injections to prevent RSV (Respiratory Syncytial Virus), one of the acute respiratory infections. As early as the first half of this year, it is expected that some products will be approved for sale in the US.
◆Group outbreaks such as postpartum care centers… Risk of pneumonia in infants and the elderly
Recently, at a postpartum care center in Gangnam, Seoul, five newborns were infected with RSV at once, and the number of patients is rapidly increasing. The number of RSV patients reported for a week from February 26th to March 4th was 214, a 2.2-fold increase from 99 cases a month ago (January 29th to February 4th).
RSV infection is an acute respiratory infection caused by RSV. It appears mainly as an upper respiratory infection such as pharyngitis, but in infants, immunocompromised persons, and the elderly, it can cause lower respiratory infections such as bronchiolitis or pneumonia, so special care must be taken.
It is characterized by easy transmission through contact with an infected person or through respiratory droplets. Symptoms include runny nose, coughing, sneezing, fever, wheezing, and shortness of breath. Among infants and young children infected for the first time, there is a risk of progressing to bronchiolitis or pneumonia. In some cases, hospitalization may be required.
It usually starts in October, peaks in January of the following year, and then occurs until March, but last year, after showing an epidemic in October-November, the number of patients decreased and increased again from February of this year. It seems that the incidence is increasing mainly in infants and young children.
◆Preventive vaccine to be inoculated once… Entering the approval review stage in large numbers
There is currently no definitive vaccine against RSV. There is a monoclonal antibody injection ‘Synagis’ (ingredient: palivizumab), which prevents by injecting a drug containing an antibody, is available in Korea, but it needs to be administered once a month up to 5 times, and the vaccination target is children with congenital heart disease, etc. is limited to It is also distinct from vaccines, which produce antibodies directly in the body by injecting antigens.
In the midst of this, a large number of vaccines under development for single inoculation have reached the approval review stage.
Recently, the US Food and Drug Administration (FDA) advisory committee recommended the use of RSV vaccines developed by Pfizer in the US and GSK in the UK for use in people over the age of 60. Pfizer is receiving approval from the FDA for maternal inoculation to prevent RSV in infants by administering to pregnant women as well as the elderly, and is planning to introduce it in Korea in the future.
It is expected that a decision will be made on whether to approve these vaccines in the first half of this year at the earliest.
US Moderna announced in January that the RSV vaccine ‘mRNA-1345’ showed a preventive effect of 83.7% in phase 3 clinical trials for the elderly. It plans to submit an application for approval to the FDA in the first half of this year. A phase 1 clinical trial for children is also underway. It is planned to be introduced in Korea in the future.
Janssen of the United States is also conducting phase 3 clinical trials for RSV vaccines.
‘Nircebimab’, an antibody injection for preventing RSV, is also undergoing approval review by the FDA. Nircebimab, which was jointly developed by AstraZeneca in the UK and Sanofi in France for infants and young children, is a drug that creates antibodies against RSV and injects it into the body. Unlike existing palivizumab, it is designed to protect infants and young children during the RSV epidemic with a single dose. It obtained permission in Europe in November of last year under the product name ‘Vaportus’.
It is still in the early stages, but in Korea, EuBiologics plans to apply for a phase 1 clinical trial plan in Australia within the year after conducting non-clinical trials for RSV vaccine development this year. SK Bioscience is pursuing new RSV candidate materials using the mRNA (messenger ribonucleic acid) platform.
“RSV is fatal because it can cause bronchiolitis and pneumonia in newborns and the elderly,” said Professor Kim Woo-joo of the Department of Infectious Diseases at Korea University Guro Hospital. It’s a huge burden,” he said.
“Several pharmaceutical companies are developing vaccines competitively,” he said. “The development started about 10 years ago, but as the development accelerates recently, it is expected to become a blue ocean next to the Corona 19 vaccine.”
“The market price of the vaccine is expected to be high,” Professor Kim said. “In Korea, it is also necessary to conduct an epidemiological investigation to find out the burden of RSV disease and the cost-benefit of the vaccine for the elderly, organ transplant recipients, and immunocompromised people.”
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