Vaccine development, one of the key keys to overcoming new coronavirus infections (corona19), is accelerating, thanks to deregulation by world’s quarantine authorities. In the overseas market, the use of emergency vaccines starting this fall and the possibility of early release of vaccines during next year are also mentioned. Domestically developed vaccines are also expected to be mass-produced in the second half of next year. However, even if the effectiveness is confirmed during the clinical process, there are very few vaccines on the market, industry insiders expect.
Vaccines usually take 10 to 15 years from development to commercialization. This is because it has to be thoroughly tested to ensure safety because it is administered to millions or billions of people. The mumps vaccine, which is considered to be the fastest developing vaccine in the history of infectious diseases, took four years. No infectious disease vaccine has been developed, such as Corona 19, that is spread by the Corona virus. However, in the case of Corona 19, unprecedented vaccine competition is taking place on the global stage, and it is predicted that it will shorten the record of previous vaccine development period.
◆ Faster clinical trial schedule… Modena, Oxford University’Acceleration’
According to the pharmaceutical bio industry on the 10th, Modena the United States of America is expected to advance the clinical trial schedule of Corona 19 vaccine (mRNA-1237), which is under development, ahead of this fall, which was scheduled to proceed, and conduct Phase III clinical trials. IT Media CNET reported, “Moderna is the beneficiary of the US Food and Drug Administration (FDA) vaccine fast track program. Phase 3 is scheduled for July.”
Modena has recently been approved by the FDA for a phase 2 clinical trial of a Corona 19 vaccine candidate and plans to deliver a vaccine candidate (mRNA-1273) to the first participant in Phase 2 clinical trials at the end of last month for a total of 600 patients. With the assumption that clinical trials will proceed as scheduled, the final development after the third clinical trial is aimed at commercializing the Corona 19 vaccine by 2021.
AstraZeneca, a UK multinational pharmaceutical company that is considered to be leading the development of corona19 vaccine, is developing a corona19 vaccine in collaboration with Oxford University in the UK and aims to develop the vaccine by September. They plan to start phase 2 and 3 clinical trials simultaneously this month, the foreign ministry said.
As AstraZeneca recently proposed a merger and acquisition (M&A) to Gilead Sciences, an American drug company that developed the flu drug Tamiflu and the Corona19 drug Remdechir, the possibility of a drug company with both Corona19 drug and vaccine is also increasing. .
When the merger between AstraZeneca and Gilliard is successful, the largest giant in the pharmaceutical industry is expected to combine AstraZeneca’s market capitalization ($140 billion/about 169 trillion won) and Gilead’s market capitalization ($960 billion/about 116 trillion won). . However, the possibility of the actual merger between the two companies is still unknown. According to industry officials, AstraZeneca did not specify the terms of the acquisition, and Gilead is also in the process of conducting internal discussions instead of official discussions between the two sides.
The clinical trial of’INO-4800′, a candidate for Corona19 vaccine developed by Innobio of the United States, began in April in the United States, and was approved in Korea on the 2nd of this month. Domestic clinical trials will be conducted at Seoul National University Hospital.
◆The government will support treatment and vaccine development goals in the second half of next year.
The Korean government is focusing on clinical trials with promising companies with the goal of developing corona19 treatments as early as this year and vaccines in the second half of next year. To this end, we decided to invest over KRW 1 trillion in K-prevention advancement, industrialization, and globalization through additional supplementary budgets and urgently provide more than 100 billion won for the cost of conducting clinical trials for therapeutics and vaccines in the second half of this year.
In the case of vaccines, protein (synthetic antigen) vaccines, DNA vaccines, and mRNA vaccines are designated as’core items for the three vaccines’, and they support promising companies to develop and produce in the second half of next year. Currently, SK Bioscience, Jinwon Life Science, and Genexine are conducting preclinical animal experiments. The government decided to prepare public and private production facilities in advance so that mass production of vaccines could be completed.
Relocation of Korean candidates for corona19 treatment candidates developed by public research institutes is also active. The National Science and Technology Research Association (NST) Convergence Research Group under the Ministry of Science and Technology Information and Communication announced a signing ceremony to transfer candidates and source technologies for corona19 therapeutics, vaccines and diagnostics to private companies from the Korean Chemical Research Institute in Daegu on the 9th. Said that it was held.
As a result of rat experiments, candidates with 3 to 5 times higher neutralizing antibody production capacity than previous vaccines are transferred to HK Innoen (formerly CJ Healthcare). The neutralizing antibody neutralizes the Corona19 virus, so the higher the neutralizing antibody producing ability, the greater the preventive effect. As a result of coronal treatment, the result of monkey kidney cell experiments is that the candidate substance, which has a 50-fold higher ability to kill Corona19 virus than Remdesivir, which is being studied by Gilead Sciences in the United States, is transferred to the domestic company “LegoChem Biosciences”.
◆Over 100 vaccines in development worldwide… Less than 6% of marketability even if clinically successful
Currently, more than 100 vaccines are being developed in the United States, the United Kingdom, Germany, Japan, and China, and 13 vaccines have been put into clinical trials. Anthony Pouch, director of the National Institute for Allergic Epidemics, said in an interview with the Journal of the American Medical Association on the 2nd that he could prepare hundreds of millions of doses (one dose) of vaccine by the beginning of next year. It is also predicted that emergency vaccines will be available in China as early as this fall. However, it seems that it will take a considerable amount of time to get it on the market.
“In the United States, the FDA-approved process usually takes more than a year, even if one or more of the vaccines currently in progress proves to be effective,” Cnet said. “It will take time,” he said.
According to Reuters, less than 6% of vaccine candidates that have completed statistically clinical trials can enter the market. This is because neutralization antibody formation, effectiveness and duration of prevention, and confirmation of the effective age range are important in addition to several technological procedures.
Neutralizing antibodies are antibodies that detect and destroy viruses. Antibodies include antibodies (non-neutralizing antibodies) and neutralizing antibodies that simply bind antigens (viruses). Neutralizing antibodies can prevent disease. In the case of the controversial Modena, all 45 said antibodies were found, but only 8 people actually developed neutralizing antibodies. The rest of the personnel may develop neutralizing antibodies over time, but Moderna is still controversial as he announces the results without waiting.
There are also technical problems such as mass production and distribution. It is the same context that Merck & Co, which participated in the vaccine development competition at the end of last month, said it would be difficult to develop vaccines within the next 12 to 18 months. “The vaccine development will require large-scale clinical trials,” said Kenneth Fraser Merck, chief executive officer. “We do not expect vaccine development to be completed in the next 12 to 18 months.”
Experts predict that vaccination may take place in two to three years since vaccines have been distributed to countries other than the United States, Europe, and China, which are leading the competition in vaccines, to African and Latin American countries. It has been pointed out that it is difficult to end Corona 19 with one specific vaccine. “We are going to need several vaccines to fight Corona 19 on the planet,” said Pouch.