Many Taiwanese have had at least three or four doses of the COVID-19 vaccine and are still infected with the Omicron virus. The official claims that “approved vaccines are all good vaccines”, but the probability of breakthrough infection and reinfection after more than three doses of the new crown vaccine is still high. When vaccine research and development cannot keep up with the speed of virus mutations, where should Taiwan’s new crown vaccine policy go?
The new coronavirus mutates too quickly. The Taiwan-approved vaccine requires two doses first. After March to May 2021, the third dose will be given following the international footsteps, and the fourth dose will be given half a year later. This year, the mRNA bivalent vaccine was introduced, including the Wuhan virus strain and the Omicron BA.1 mutant strain first, followed by BA.5.
Existing spike protein vaccines may not last long
However, a study by Harvard University and Columbia University found that after 28 days after the fourth dose of mRNA bivalent vaccine, the effectiveness of neutralizing antibodies against Omicrons and the efficacy of T cells were not superior to those of the original; in line with the original immunoblot (immune imprinting) theory, that is, most of the antibodies will react with the first encountered Wuhan virus strain, and only a small part can neutralize the Omicron virus.
What is more noteworthy is that in November this year, new mutant strains such as BQ.1.1, XBB, BF.7, and BA.2.75.2 are climbing. Their immune escape ability is much greater than that of BA.5, and they are waiting for an opportunity to dominate the spread in winter. Therefore, in the face of newer mutated virus strain vaccines, such as BA.5 vaccine, we must rethink their necessity and feasibility, and avoid doubts such as sluggish or weakened immunity after frequent vaccinations.
Figure/The target antigens of currently approved vaccines are mostly spinin proteins, and the protection is difficult to last.Photo by Chi Mengyu
After careful investigation, most of the target antigens of currently approved vaccines are spinin proteins, and the efficacy and importance of non-spike proteins are completely ignored.
In fact, vaccines containing only echinoprotein only trigger weak T cell immunity, allowing B cells to produce neutralizing antibodies that decline quickly. Although they can temporarily block virus invasion, they are difficult to last for a long time. Additional doses must be administered frequently, which is extremely unfavorable for mass vaccination of public health , And even if the bivalent vaccine is given, it may be re-infected.
Omicron starts fourth, fifth doses of vaccine
On the other hand, the Alpha virus spread around the world in early 2021; then the Delta virus spread around the world, because it can invade the lungs and cause severe illness and death. At the end of November 2021, another breakthrough infection case was added, and Israel took the lead in administering the third dose; afterward, the spinin vaccine prepared with the Wuhan virus strain was tested by Omicron BA.1, BA.2 and BA. 4/5 of the virus breakthroughs opened the first of its kind for the fourth and fifth doses.
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Omicron virus only infects the upper respiratory tract, but each reinfection tends to aggravate and prolong the after-effects of the new crown, which are often worse than the confirmed symptoms. Based on the multiple mutations of the new coronavirus, immune escape, and viral receptors all over the body, future epidemic prevention must prevent and control “re-infection” to avoid catastrophe if a new mutant virus that can invade the lungs appears.
Taiwan’s new crown vaccine development, initially there were three domestic vaccine companies, including Guoguang, which successfully manufactured the new human influenza H1N1 vaccine in 2009 with full automation; High-end, which has experience in developing enterovirus type 71; , is highly anticipated by all parties.
Domestic vaccines differ from international review standards
According to international requirements, vaccine evaluation must go through Phase III clinical trials.
The first phase determines the safety of the vaccine and the optimal antigen dose. The second phase increases the number of people and tests the most appropriate immunogenicity. The third phase randomly assigns participants to the vaccine group and the control group. The comparability of the distribution of factors such as gender and health, and then examine its protective effect. Whether to grant EUA is decided after the professional review of the safety and quality control results of a larger research group.
Photo/The review standards of domestic vaccines are different from those of international ones.Taken from high-end official website
On July 23, 2020, the CDC stated that at least 1,300 people (1,000 people in the vaccine group) should be accepted for the second phase of clinical trials; however, the number of participants in the vaccine group must reach 3,000 in order to receive a maximum subsidy of NT$300 million.
On October 22, 2020, the government unit announced the emergency use authorization (EUA) review rules for vaccine factories; decision makers want to skip the third phase of clinical trials and expand the review of the results of the second phase of clinical trials earlier. There is no subsidy for the third-phase trial fee, which is very different from the style of vaccine evaluation and huge subsidies for vaccine research and development in Europe and the United States.
However, the small number of COVID-19 cases in Taiwan precludes a realistic scientific assessment of the vaccine’s protective power. From April to June 2021, Taipei City and New Taipei City coincided with the pandemic of the Alpha variant virus. Shuangbei City is extremely short of vaccines, and the number of severe cases and deaths has risen. Unfortunately, relevant units have not seized this popular opportunity to evaluate vaccines against the variant virus.
High-end vaccines pass the evaluation of protection benefits!Su Yiren is disappointed: EUA should leave
On June 10, 2021, the Food and Drug Administration decided to use the immune bridging anti-Wuhan virus strain neutralizing antibody as the EUA review standard after the second phase of clinical trials; after the Alpha virus epidemic caused heavy casualties, it still did not pay attention to the actual effect of anti-mutant viruses. A domestically produced vaccine was the first to release an interim report that night.
In fact, two weeks after two doses of the vaccine is the peak of antibodies, it will be more convincing to really evaluate the public health benefits by looking at the complete data of all immune dynamic changes three to six months after the vaccination.
On July 19, the Food and Drug Administration approved the EUA of my country’s first domestically produced vaccine. On August 16, the Food and Drug Administration “failed” the EUA review of another domestic vaccine based on the only antibody data at a single point in time.
Since then, many mutant viruses have swept the world, and new viruses spread faster. To evaluate the immune efficacy of vaccines at this stage, it is necessary to look at the “overall immune dynamic effect of additional doses”, including: the magnitude and persistence of neutralizing antibodies, B cell immunity, and T cell immune responses. 2 to 4 weeks for peak antibodies.
Domestic T cell vaccines have made great breakthroughs, but the vaccine policy is stagnant
In addition, T immune memory cells can remain in the body for several years, longer than neutralizing antibodies; more scientifically confirmed that after neutralizing antibodies fade, T cell immunity can clear the virus in the cells, maintain the long-lasting immunity of the vaccinated, and prevent the disease from worsening And the protective effect of preventing severe illness and reducing death is very important.
The domestically produced vaccines that had been subject to EUA slippery iron furnace were sent to the Food and Drug Administration with the latest data this summer, and it was found that the review standards were still stuck in the old way of thinking!
As of November this year, this domestic vaccine has published four immune evaluation articles in influential international journals, pointing out that its unique multi-antigen (five segments of four viral proteins) can jointly stimulate multiple immunity, especially the “supplementary dose ”The neutralizing antibody data against Delta, Omicron BA.1, BA.2, and BA.5 four mutant viruses are the highest among all international vaccines, and the antibody persistence and induced T cell immunity are also far greater than other new crown vaccines.
2 pictures to understand the ranking of 4 new crown vaccines regardless of age, BNT is the strongest “high-end wins Modena”
On November 16, Pfizer Vaccines announced that it is developing a T-cell vaccine (BNT162b4) that uses the non-spinolin-retained epitope region as an antigen, and will incorporate the BA.5 bivalent vaccine, which is expected to generate a strong and long-lasting immune memory T-cell response. Maintain the endurance of immune B and T cells and neutralizing antibodies.
This is a testament to the foresight of our domestic vaccine pilot design and the reference of the follow-up results. Unfortunately, this high-quality immunization domestic vaccine has not received due attention from policy makers, and it has buried a good opportunity to contribute to global health for 16 months!
In other words, my country’s Food and Drug Administration, CDC, and command centers missed the opportunity to deploy and evaluate domestic vaccines ahead of time during the domestic COVID-19 pandemic; when the world pays attention to the actual combat effectiveness of BA.5 and other variant viruses, they have not kept up with the times Progress!
Endless vaccinations?Jin Chuanchun made five suggestions
This autumn, viruses that escape neutralizing antibodies are also rampant in many places. However, the public is already tired of the endless vaccinations such as the fourth and fifth doses, so I sincerely suggest that the government:
1. Firstly, vaccine EUA and certification standards should be formulated in accordance with international standards, and vigorously assist the domestic vaccine industry to gallop internationally;
2. Take the lead in developing and formulating immune indicators such as T cells, and cooperate with neutralizing antibodies as the overall immune evaluation standard;
3. Support the development of vaccines to reach at least the results of Phase III clinical trials, urge international cooperation to increase the evaluation data after vaccination, and obtain international certification early to ensure that Taiwan’s vaccines can reach international standards that can maintain national security and contribute to other countries’ epidemic prevention;
4. Urge the CDC and NHS to release vaccine data to facilitate the analysis of the vaccine industry and accelerate product development, so that Taiwan’s vaccine evaluation will once again become the international leader after the hepatitis B vaccine;
5. The National Institutes of Health should hold a seminar on the overall planning of the new crown vaccine to brainstorm.
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