Journal reporter: Zhang Lingxiao Editor: Gao Han Picture source: Vision China On December 18, local time, the U.S. Food and Drug Administration (FDA) approved the emergency use of the new coronavirus vaccine mRNA-1273 developed by the American biotechnology company Moderna. Autho

Every reporter: Zhang Lingxiao Every editor: Gao Han

Picture source: Visual China

On December 18, local time, the U.S. Food and Drug Administration (FDA) approved the new coronavirus vaccine mRNA-1273 developed by the American biotechnology company Moderna. The emergency use authorization is the second vaccine approved for use in the United States after the BNT162b2 COVID-19 vaccine from Pfizer and the German biotech company BioNTech.

The day before, the U.S. Vaccines and Related Biological Products Advisory Committee (VRBPAC) held an online meeting and voted in favor of approving the emergency use authorization application for Moderna’s new crown vaccine.

A report related to the Moderna vaccine released by the FDA shows that injections of the vaccine may cause side effects such as nausea/vomiting, facial swelling, fatigue, headache and muscle pain, which has aroused public concerns about the safety of the vaccine. Yasir Batalvi, a 24-year-old volunteer who participated in the Phase III clinical trial of Moderna's new coronavirus vaccine, told the "Daily Economic News" reporter that both injections of the vaccine caused him to experience varying degrees of side effects.

Eric Rubin, editor-in-chief of the famous medical journal " New England Journal of Medicine " and visiting professor of the Department of Immunity and Infectious Diseases at Harvard T.H. Chan School of Public Health, said in an interview with reporters that he speculated on the composition of the mRNA vaccine The structure may have something to do with its side effects, many of which may stem from the lipids used to encapsulate the mRNA. But he also believes that the side effects currently described are very similar to those of many other vaccines, and serious side effects are still quite rare, so the vaccine is still safe and effective.

Vaccine confirmed to be effective Trump: Distribute immediately

General Gustave Pena, who is responsible for supervising the distribution of the U.S. "Operation Warp Speed" project, previously revealed that after the FDA successfully approved the Moderna vaccine, it will be released next week Just under 6 million doses of vaccine have been shipped to the United States.

On the evening of December 18th, Beijing time, US President Trump posted on Twitter that the Moderna vaccine had been approved and would be distributed immediately. The mRNA-1273 vaccine developed by

Moderna is based on the RNA-encoded SARS-CoV-2 spike glycoprotein (S) antigen and is made with lipid nanoparticles (LNPs) technology. According to an FDA document, Moderna's Phase 3 randomized, double-blind, placebo-controlled trial confirmed that its vaccine was 94.5% effective in preventing symptomatic COVID-19 disease.

A total of 30,418 volunteers participated in the experiment, of which 15,208 volunteers received two doses of vaccine 28 days apart, and the remaining 15,210 volunteers received two doses of placebo at the same time. The trial results showed that 95 people were infected with the new coronavirus , of which only 5 were vaccinated and the other 90 received a placebo. The

document also showed that the vaccine was similarly effective across ethnic groups and people with underlying medical conditions, with an efficacy rate of 86.4% among those 65 and older and 86.4% among those 18 to 65 years old. is 95.6%. The

report believes that Moderna’s clinical trial results and safety data are “consistent with the recommendations made in the FDA’s “Emergency Use Authorization Guidelines for Vaccines to Prevent COVID-19”. The mRNA-1273 vaccine prevents “at least 14 days after the second dose of injection.” "Very effective" in symptomatic COVID-19. The analysis of the accumulation curve of COVID-19 cases in the

report showed that about 14 days after the first vaccination with mRNA-1273, there was a significant difference in the accumulation curve of COVID-19 cases in the control group and the vaccine group. Data show that within 14 days after the first vaccination, the protective efficacy of the vaccine was 50.8%, and 14 days after vaccination, the protective efficacy of the vaccine reached 92.1%.

On November 30, Moderna submitted an emergency use request to the FDA. The Vaccines and Related Biological Products Advisory Committee, an independent expert advisory group to the FDA, held a meeting on December 17, Eastern Time, and conducted a day-long discussion on the Moderna vaccine. In the final vote on vaccine use application, Moderna vaccine received 20 votes in favor, 0 votes against and 1 abstention.

Moderna vaccine volunteers: Side effects left no sequelae

Since the UK approved the Pfizer vaccine last week and took the lead in starting vaccination work, news of serious side effects after vaccine injection have followed one after another, causing public concern.

During the review meeting for the Moderna vaccine, the possible side effects of the vaccine were also one of the focuses of discussion among the committee experts.

FDA disclosed in the briefing that local reactions and systemic symptoms are common in volunteers after vaccination, and most are mild to moderate.

Yasir Batalvi, a 24-year-old volunteer who participated in the Phase III clinical trial of Moderna's new crown vaccine, told the reporter of "Daily Economic News" about his experience in participating in the trial.

In July this year, Batalvi registered in Boston in the United States to join the Moderna vaccine project. On October 15 and November 12, he took the first and second injections of the drug respectively. Both injections caused Batalvi to have varying degrees of side effects.

“About 30 minutes after the first injection, my left arm felt a little stiff and numb, and it felt painful, like someone had punched me in the arm. This was very similar to the side effects I had from previous flu shots. But these symptoms disappeared quickly the next night," Batalvi told reporters.

"The side effects after the second injection came faster and were more serious. After I received the vaccine that afternoon, I developed a low fever that night, my left arm muscles were stiff, and I showed fatigue, headache, and some related symptoms. I told the doctors involved in the trial about my situation, and they told me not to panic, saying that it was a normal side effect that every vaccine recipient would experience. After taking some painkillers, the side effects disappeared. "

Batalvi said that he is currently in good health and the side effects have not left any sequelae.

According to reports, fatigue, headache and muscle pain are the most common side effects caused by the mRNA-1273 vaccine, while some rare symptoms, such as uncontrollable nausea or vomiting and facial swelling, are also reported, which are likely to be caused by the injection. of. The FDA says some side effects are difficult to eliminate, but most disappear within a week.

It is worth noting that the mRNA-1273 vaccine developed by Moderna and the BNT162b2 new crown vaccine of Pfizer and BioNTech are both mRNA vaccines. According to the data released by the FDA, the former has a higher chance of side effects than the latter.

FDA report shows that the most common adverse reactions of the mRNA-1273 vaccine are injection site pain (91.6%), fatigue (68.5%), headache (63.0%), myalgia (59.6%), joint pain (44.8%) and chills (43.4%); 0.2% to 9.7% of participants reported serious adverse reactions, with serious adverse reactions occurring more frequently after the second dose than after the first dose.

In comparison, the common adverse reactions of BNT162b2 vaccine are injection site reaction (84.1%), fatigue (62.9%), headache (55.1%), myalgia (38.3%), chills (31.9%), joint pain (23.6 %), fever (14.2%); the incidence of serious adverse reactions ranges from 0.0% to 4.6%.

In fact, Arnold Monto, an epidemiologist at the University of Michigan School of Public Health and one of the executive chairs of the Vaccines and Related Biological Products Advisory Committee, once mentioned that the Moderna and Pfizer and BioNTech new crown vaccines cause more complications than the level of side effects that people are accustomed to. Serious side effects were more frequent. He said: "Compared with most influenza vaccines, even high-dose vaccines, the mRNA new crown vaccine is more reactogenic."

Image source:Visual China

Experts: Side effects are mostly local

Except for the most common side effects In addition to the problems, the cases of facial nerve paralysis reported in Moderna's new crown vaccine trial also attracted the attention of the Vaccines and Related Biological Products Advisory Committee.

The FDA report shows that 4 participants in the Moderna new crown vaccine trial developed symptoms of facial nerve paralysis, of which 3 were in the vaccine group and 1 was in the placebo group. A previous report on the Pfizer and BioNTech vaccine released by the FDA also revealed that four volunteers who received the COVID-19 vaccine in the Phase III trial developed this symptom.

However, the FDA believed in both documents that there is currently insufficient evidence to prove that there is any connection between the facial paralysis in subjects and the vaccine. For now, the agency is only calling for surveillance of vaccinated individuals related to such cases.

As a member of the Vaccines and Related Biological Products Advisory Committee, National Institutes of Health (NIH) expert Michael G. Kurilla once questioned this. COVID-19 patients will lose their sense of taste and smell. It may be that the immune response induced by the virus damages the special ones. Caused by nerve cells, how can facial paralysis, an obvious neurological disorder of facial muscles, be interpreted as having nothing to do with vaccine induction?

But two voting members of the Vaccines and Related Biological Products Advisory Committee expressed a different view.

Eric Rubin analyzed to the reporter of "Daily Economic News" that it is still not possible to determine whether the occurrence of facial paralysis cases is directly related to vaccination. "In the current situation, the most important thing is to classify cases of facial paralysis as an 'adverse reaction of special concern.' In other words, I think the FDA and other international regulatory agencies will continue to actively investigate to see whether the number of patients experiencing this symptom exceeds Stanley Marc Perlman, professor of microbiology and immunology and professor of pediatrics at the Roy J. and Lucile A. Carver School of Medicine at the University of Iowa, also told reporters that it is still too early to draw conclusions. Further investigation is needed. But one thing worth paying attention to is that among the current cases of facial paralysis, 7 of the 8 cases appeared in the vaccine group.

So what are the side effects of vaccines? Do people need to carefully consider vaccination?

Rubin speculated that the composition and structure of the mRNA vaccine may be related to its side effects. He believes that many of the side effects may stem from the lipids used to encapsulate the mRNA. Previously, in animal experiments, lipid nanoparticles without mRNA were found to produce inflammatory mediators in animal muscles, which can cause pain, redness, swelling, fever, flu-like symptoms, etc. At the same time, Rubin added that Moderna, Pfizer and BioNTech have not disclosed the composition of their vaccines in detail, and the two vaccines may still have many differences and cannot be generalized.

From the perspective of widespread vaccination, Perlman agreed with the FDA’s judgment on the rationality and safety of the two mRNA vaccines. "Most of the side effects are local, proving that the vaccine is reactive. But there are currently almost no cases of major adverse reactions. We will continue to track the occurrence of side effects in vaccine recipients."

Rubin also holds the same opinion. He said, "The side effects described so far are very similar to those of many other vaccines, and serious side effects are still quite rare. We believe that the number of people vaccinated now is actually relatively small, (the current conclusion may be in the future changes), but from the current point of view, the number of people experiencing side effects is much less than those infected with the new coronavirus.”

Daily Economic News