Domestic coVID-19 vaccine development has entered the final sprint stage.
On the evening of June 20, CCTV news reported that three of China’s five coVID-19 vaccines approved for clinical trials have completed phase II clinical trials.
With the coVID-19 vaccine research and development into a heated debate, vaccine positive progress rekindled enthusiasm for pharmaceutical stocks investment.
Although the methods and paths adopted by different people are different, who can go to the end smoothly is still limited by multiple factors such as the number of target groups, security, financial support and approval.
Although the report did not announce the team name, public data shows, the current domestic have entered the second phase of clinical phase of the three respectively Kang Xinuo creatures and military academy of sciences institute of medicine of China biological age group, its group of wuhan institute of biological products, Beijing branch of zhongshan vitamins technology co., LTD. (hereinafter referred to as “sinovac”).
According to Wang Junzhi, deputy head of the vaccine r&d expert group under the joint prevention and control mechanism and an academician of the Chinese Academy of Engineering, clinical trials of vaccines are divided into three phases.
Phase II clinical observation of immunogenicity and safety indicators;
Phase III clinical observation is mainly in the epidemic population, epidemic areas, to observe whether the vaccine can prevent human infection, the rate of protection observed.
“The completion of phase III clinical trials is the most critical element for the eventual success of vaccine development in China.”
Wang Junzhi said.
Only a week ago, Sinopharm announced the results of the trial: None of the vaccinated had a serious adverse reaction;
The vaccinees in the vaccine group all produced high titer antibody, and the positive conversion rate of neutralizing antibody reached 100% after two doses of routine inoculation on 28 days.
This means that the safety and efficacy of the vaccine have been fully verified.
Affected by the news, on June 17, sinopac shares rose by the daily limit, Hong Kong shares sinopac holdings higher than 5%, sinopac rose 3%.
However, the “resource war” to find suitable target population for clinical phase III and complete mass production within a short period of time is the highest threshold for coVID-19 vaccine.
“Covid-19 vaccines have to be done in endemic areas to complete phase III clinical trials, and that process takes some time.”
Wang Junzhi said.
Zhang Wenhong, director of the Department of Infection in Huashan Hospital affiliated to Fudan University, said frankly that the epidemic situation in China has been very well controlled, but we have lost the opportunity to conduct phase III clinical research in China.
“If we want to do clinical research on coVID-19 vaccine, we have to go to foreign countries where there is a high incidence of coVID-19.”
Zhang Wenhong said.
Chen’s team has been approved by Health Canada for clinical trials.
Sinopharm has established cooperation intention with enterprises and institutions in many countries;
Sinovac also announced a phase III clinical trial with the Brazilian Institute of Biological Research.
However, many failed vaccines fail not in phase I and II trials, but in phase III trials involving more people.
“With regard to vaccine development, Beijing has made a very big strategic layout. It has opened an industrial base of nearly 70,000 square meters in The Daxing Pharmaceutical Park. The production workshop is under construction 24 hours a day.
Beijing sinovac to Beijing Business daily reporter introduced that.
After all, it is not easy for any independent company to build factories, production lines and mass production quickly in a short time.
Only a week earlier, Sinovac had published the results and announced a phase III trial with a Brazilian research institute.
The schedule is strictly in place.
You don’t have to make a vaccine?
In fact, by the novel coronavirus vaccine impact, the recent rise of the relevant pharmaceutical stocks huge.
June 17, A share biological vaccine plate opened strong, up to the close of the plate up to 3.72%.
Choice financial terminal data, A shares of the biological vaccine sector contains A total of 32 stocks, by the end of the day,29 stocks rose.
Information according to the Chinese vaccine industry association, according to the current domestic total of 17 member units are conducting COVID – 19 vaccine development work, involving the listed companies have Kang Xinuo biological, KTS, made by hualan bio-engineering, liaoning cheng da listed companies, on the other hand, private enterprises in wuhan bovo, Beijing farce cheng hai hui also in research and development, etc.
Most of these companies have not had the good fortune of Sinovac. Without financial support, not all of them are able to complete the development and marketing of coVID-19 vaccine.
In fact, not all companies aim to develop marketable coVID-19 vaccines.
On June 5, Legend went public on NASDAQ. The opening price and the offering price were both $37, up 60.86% from the offering price, giving Legend a market value of $4.786 billion at the opening price.
Public information shows that Legendary biological nanjing Kingsley subsidiary.
In may of this year, kingsley announced a full collaboration with simicrobe on the novel coronavirusmRNA vaccine project, a clinical trial with a novel coronavirusmRNA vaccine.
Legendary has since announced $150 million in funding, valued at $1.95 billion, from Hudson Bay Capital Management, Lilly Asia Capital and JJDC, Johnson & Johnson’s strategic venture Capital fund.
By contrast, the legendary creature had a hard time before.
Legendary lost $133 million in 2019 and another $44.23 million in the first quarter of 2020.
Beijing Business Daily reporter contacted Kingsley, as of press time, did not receive a reply.
Some people take advantage of listing, some people take advantage of profit.
On June 16, Xizang Pharmaceutical Announced that it was granted the exclusive rights of global development, registration, production, use and commercialization of coVID-19 vaccines developed by SGI.
Since May 25, Xizang’s share price has soared by 137% in less than a month.
Ge Weidong, chairman of Shanghai Chaos Investment Co., and the third largest shareholder of Xizang Pharmaceutical, also invested heavily in 7.812 million shares of Xizang Pharmaceutical, accounting for 4.41% of the company’s total share capital. Based on the share price as of June 16, the total value of the shares reached 480 million yuan.
Therefore, insiders said, for Xizang Pharmaceutical disclosure of good news before the stock price has gone up, whether there is inside information leaked in advance or letter not timely, will shareholders take the opportunity to reduce the situation, these issues remain to be seen.
As a matter of fact, In January this year, Si Wei biotechnology has cooperated with Dongfang Hospital affiliated to Tongji University to carry out the research and development project of mRNA vaccine against COVID-19.
So far, however, no clinical trials have been reported.
“There is no doubt that there will be a group of companies that benefit from market speculation during a pandemic, but in the end the data speak for themselves.”
Richard Albright, a professor at Rutgers University, told The Beijing Business Daily.
Return to the security
Perhaps it is time for a more rational approach to coVID-19 vaccines.
Xizang previously said that if the research and development failed, the company would face the risk of not being able to recover the funds already paid and related clinical costs.
Xizang Pharmaceutical will invest 351 million yuan in Si Microbe in stages, according to an announcement by the province.
How much does a coVID-19 vaccine need to cost from development to market?
The non-profit Innovation Alliance for Epidemic Prevention estimates that to hedge against research and development failure, the number of vaccine candidates needs to be expanded at the outset, with the target of three vaccine candidates to be filed for market by 2021 needing about $2bn.
According to media reports, the EU has finalized 400 million vaccine proposals, among which India has been granted a license to produce 1 billion vaccines at an estimated price of 10 euros per vaccine.
This means that the price of each coVID-19 vaccine is no more than 80 yuan, and companies need to sell nearly 200 million doses to cover the cost, excluding sales expenses.
In January this year, the Wuhan Institute of Biological Products and the Wuhan Institute of Virology, Chinese Academy of Sciences started research on coVID-19 vaccines.
It takes only half a year to go from development to clinical phase III, whereas vaccine development is usually measured in “years”, not a year or two, but eight to 20 years.
Doubts persist about the “fast track” coVID-19 vaccine.
“At the current clinical pace, it is too early to say how long these neutralizing antibodies will last.
Also, many companies in the industry are following the example of publishing clinical data before it is officially published, which is contrary to scientific rigor.”
Richard Albright said.
Back to the original question: Can an overheated vaccine be safe?
In fact, efforts are being made to improve vaccine safety.
On June 18, five ministries and commissions, including the National Health Commission and the Ministry of Science and Technology, jointly issued the General Requirements for biosafety in vaccine production workshops, stating that enterprises should establish and improve biosafety systems and take safety measures based on risk assessment, and should report them to local public security organs for the record.
“We are not doing this as a team, as a business.
“There are already two or three inactivated vaccines in The clinical stage in China, which can provide a lot of data for drug regulators and the government to evaluate the safety and efficacy of the vaccine.”
Yin Weidong, chairman of Sinovac, said the government and the drug regulator are constantly evaluating the results of each study and will approve the vaccine for market or emergency use based on the results and risk assessment.