China’s research team has once again taken an important step in the development of the new crown vaccine. On the evening of May 22, The Lancet, an international academic journal, published a new coronavirus vaccine developed online by a team of Chinese academy of engineering academician Chen Wei. The results showed that the vaccine was safe and that antibodies were successfully produced in volunteers.
At the same time, the authors note that while the results of the trial show good prospects for the vaccine, further validation of the vaccine’s effectiveness is needed, and it is too early to talk about the vaccine coming to market.
It is worth noting that this is China’s first new coronary vaccine human clinical data results, but also the world’s first new coronary vaccine human clinical trial paper.
Professor Chen Wei, who led the study, said:
“The trial showed that a single dose of the new adenovirus new coronavaccine could produce virus-specific antibodies and T-cells within 14 days, making further research possible.” “
“However, the challengeof developing a new coronavaccine is unprecedented, and the ability to trigger these immune responses does not necessarily indicate that the vaccine will protect humans from the new coronavirus, a result that only shows hope for the development of a new corona vaccine, but is a long way from being able to use it for all.” “
Initially confirmed to be safe and effective
The development of effective vaccines is seen as a long-term solution to the control of new coronaviruses. More than 100 candidate COVID-19 vaccines are currently under development worldwide.
According to the paper, the study was conducted in an open label trial in 108 healthy adults to evaluate the new coronavaccine, which is carrierd with adenovirus Ad5: a rapid specific T-cell response was detected on the 14th day after vaccination, and a peak response to SARS-CoV-2 body fluid immune response sat out on the 28th day, with no serious adverse events detected.
Between March 16 and March 27, 2020, the team screened 195 volunteers, 108 of whom (51 percent male and 49 percent female; with an average age of 36.3) were recruited and assigned to three dose groups – the low dose group (5 x 1010), the medium dose group (1 x 1011) and the high dose group (1.5 x 1011).
Within 28 days of vaccination, the researchers evaluated the safety and efficacy of the vaccine, including:
Adverse events occurring 7 days after vaccination;
Specific antibodies are measured by ELISA;
Neutralizing antibody response induced after vaccination by neutralizing and testing of SARS-CoV-2 virus and its pseudovirus esmo
The immune response of T cells was detected using enzyme-linked immunospeckles and flow cytometry.
It was found that adverse reactions were reported in the first 7 days after vaccination, with 30 (83%) in the low dose group, 30 in the medium dose group (83%) and 27 (75%) in the high dose group.
The most common adverse reactions at the injection site were pain, with a total of 58 cases reported by vaccinators, and the most common systemic adverse reactions were fever (50 cases (46%), fatigue (47 cases (44 percent), headache (42 cases (39%)) and muscle pain (18 cases (17%)).
Most adverse reactions reported in all dose groups were mild or moderate in severity, and no serious adverse events were detected within 28 days of vaccination. ELISA antibodies and neutralizing antibodies increased significantly on the 14th day and peaked 28 days after inoculation (body fluid immunity);
In other words, the new coronavirus, which is carrierd with adenovirus Ad5, showed good tolerance in Phase I clinical trials and produced an immune response to the new coronavirus (SARS-CoV-2) in the human body. Specifically, however, the final results of the study will be evaluated continuously within six months, and further tests are needed to determine whether the immune response is effective in preventing SARS-CoV-2 infection.
However, despite multiple trials showing that volunteers had an immune response to the new adenovirus (common cold virus vector/vector) vaccine, and that both antibodies and T-cell responses could be reduced, Chen’s team noted that 44%-56% of the volunteers involved in the study had high established immunity (the original immunity was very strong, not related to the vaccine), and that the antibody and T-cell response to the vaccine was weak. Therefore, this result is only a reference nature, and further large-scale experiments are required for in-depth analysis and evaluation.
Therefore, this preliminary result does not mean that the Ad5-nCoV vaccine has been able to produce an effective immune response, protecting people from the virus, but rather the ability to stimulate the body’s immune system, producing an initial immune response. And its greatest value is to prove that the vaccine is worth continuing to develop, entering the follow-up Phase 2-3 clinical trial to fully test its safety, protection effect, and ultimately whether it can be used in humans.
But either way, it’s really good news.
Chen Wei: Vaccines have the potential to be further studied and developed, but the results of the trial should be interpreted with caution
The result quickly caused a stir in the industry. Richard Horton, editor-in-chief of The Lancet, praised the first human trials, which found it to be safe and resistant, and was able to induce a rapid immune response. “These results represent an important milestone.”
The Lancet also said through its official microblog: The first Phase 1 clinical trial of the COVID-19 vaccine is safe and well tolerated, and can produce an immune response to SARS-CoV-2 in the human body. The trial, an open label trial of 108 healthy adults, showed promising results after 28 days and the final results will be evaluated within 6 months. However, further tests are needed to determine whether the immune response is effective in preventing SARS-CoV-2 infection.
Netizens have also sent a blessing voice: look forward to the early development of the vaccine success!
But as Academician Chen Wei said: “The results of these trials should be interpreted with caution.” The challenge of developing a new coronary vaccine is unprecedented; even if it has the ability to trigger the aforementioned immune response, it does not necessarily mean that the vaccine will help protect people against the new coronavirus. “
According to the Beijing Daily, the vaccine’s Phase II human clinical trial was launched on April 12, making it the only new coronavirus vaccine in the world to enter Phase II clinical trials at the time. On April 25, Chen Wei revealed at the National Children’s Vaccination Day Theme Live Event that 508 volunteers from the Phase II clinical trial of the new corona vaccine have been injected and are in the observation period and, if all goes well, will be blinded in May.
Although the results of this trial can not completely prove that the vaccine can be developed successfully, but this is also a very critical step in the vaccine development process, we look forward to more good news, look forward to the new corona epidemic can be completed soon.