By Ivan Maltsev
The drug is ready for clinical trials: experts are waiting for the results.
China has announced that it is ready for clinical trials of the world’s first drug against COVID-19 based on the plasma of patients who have recovered from coronavirus. It is expected that the drug will be effective in severe cases.
The world’s first drug against COVID-19 based on human immunoglobulin, created from the plasma of recovered patients with COVID-19, will undergo clinical trials, said Zhu Jingjin, vice president of China National Biotec Group (CNBG).
According to the Chinese edition of the Global Times, the plasma of convalescents was previously included in the national treatment plan for COVID-19 and showed a perfect effect for treating seriously ill and severe patients with COVID-19. This is reported by the official WeChat account of the State Assets Supervision Commission and the State Council Administration (SASAC).
China National Biotec Group (CNBG) said that its latest second-generation COVID-19 vaccines, developed specifically for the currently common variants of the coronavirus, such as Delta and Beta, also showed good initial results.
As of Saturday, more than 2.1 billion doses of the COVID-19 vaccine had been administered across China, according to national health authorities on Sunday. On Sunday, the main manufacturer of vaccines in China, Sinopharm, said that it had submitted an official vaccination plan for approval.
A new drug developed from the plasma of recovered patients with COVID-19 or vaccinated uninfected people contain highly active neutralizing antibodies against SARS-COV-2. Preclinical studies and animal tests have already been completed, which showed significant relief of symptoms and injuries caused by the new coronavirus infection. Soon testing of the drug will enter phase III, the Global Times reports with reference to CNBG.
Due to the lack of new drug resistance to the new coronavirus that is spreading around the world, CNBG, learning from the experience of SARS, has developed convalescent plasma as a therapy for the treatment of critical and severe cases.
“The drug can be widely used and provides a rapid response in emergency care for severe patients or high-risk groups,” Zhu Jingjin said.
“But the real effectiveness of a special drug still depends mainly on the results of clinical trials, and not on the conclusions at the early stages,” Jiang Chunlai from the School of Natural Sciences of Jilin University comments to the Global Times.
Experts warned that prevention and vaccination remain the most effective means of fighting infection since specific medications provide relief only to a limited extent.
“Since after infection, the virus uses human cells to replicate new viruses constantly; such a human immunoglobulin can neutralize the virus only outside the cell. Cellular immunity is important with vaccines,” says Tao Lin, a COVID-19 vaccine expert from Shanghai.
Another professor of immunology from Beijing, who preferred to remain anonymous, warned that the drug might contain a risk of infection with other viruses, such as hepatitis B and HIV, as well as other infectious diseases transmitted through the blood.
CNBG has previously stated that it strictly followed the procedures for checking the provided plasma.
The drug and vaccines were presented at the China International Fair for Trade in Services (CIFTIS) in 2021. The company also introduced another drug-the monoclonal antibody, 2B11, which, according to animal tests, significantly reduces lung inflammation caused by coronavirus infection. The next step in working on this drug is clinical trials.
CNBG also presented prototypes of two updated vaccines – a recombinant broad-spectrum protein vaccine and its own mRNA vaccine, which are particularly effective in combating mutations.
The updated inactivated vaccine against COVID-19 is undergoing phase III clinical trials in the United Arab Emirates. Preclinical and clinical trials have shown good results so far, Zhu Jingjin said, noting that manufacturers are also preparing a platform for mass production of an mRNA vaccine of their own design.