Moderna New Crown Vaccine Expert Opinion 20-0 Supports Emergency Make...

Source: 6:10 a.m. Beijing time on December 18, the U.S. FDA on the Moderna New Crown (COVID-19) vaccine mRNA-1273 emergency use authorization (EUA) expert meeting has just concluded.
After more than eight hours of extensive discussion of the Moderna new crown vaccine throughout the day, outside experts voted 20 to 0 against and 1 abstention, arguing that the benefits of Moderna's COVID-19 vaccine in individuals 18 years of age and older outweighed its risks, based on all available scientific evidence.
FDA released a review in favor of the Moderna vaccine ahead of the meeting, almost guaranteeing expert support for the vaccine, the EUA.
"Moderna New Crown Vaccine Expert Meeting Data, Very Effective but More Adverse Reactions" Although the FDA does not have to follow the recommendations of the Expert Meeting, based on the experience of last week's Pfizer/BioNTech vaccine, the FDA is widely expected to release the EUA within the next day.
Pfizer's New Crown Vaccine Experts, 17-4 in favor of emergency use authorization: Moderna's vaccine and Pfizer/BioNTech's vaccine are both mRNA vaccines, acting in the same vernacency.
clinical trials have shown that both vaccines are very effective, protecting about 94% and 95%, but both vaccines can cause side effects in some vaccinators.
the results, the panel appears to have voted more positively for the Moderna vaccine than last week's vote on the Pfizer vaccine (17-4).
But this seems to be more about procedure, with Moderna's EUA application for the COVID-19 vaccine mRNA-1273 requiring only the vaccine to be used in people 18 years of age and older, while the Pfizer/BioNTech vaccine's EUA is aimed at people 16 years of age and older.
Pfizer's vaccine, which includes data from only 153 people aged 16 and 17, was the point questioned by some panels at a panel of experts last week, when several experts voted against the Pfizer vaccine's EUA recommendation.
, Moderna's vaccine only covers people over the age of 18, so experts have no problem with adolescent vaccination.
, which maintains a placebo-controlled program after receiving an EUA, has unveiled a plan to provide a vaccine to volunteers who received a placebo in its clinical trials, a program that appears to convert volunteers more quickly than the Pfizer/BioNTech program for its COVID-19 vaccine last week.
the FDA and a panel of experts continue to oppose the premature provision of vaccines to volunteers, the company says it believes there is a moral obligation to provide vaccines to placebo recipients.
the FDA and the panel debated the existence of this obligation, instead arguing that providing the vaccine to volunteers receiving a placebo would limit the quality of data on the long-term effectiveness and side effects of the vaccine.
and BioNTech programs provide vaccines to volunteers in the placebo group based on the order of vaccinations recommended by the U.S. Centers for Disease Control and Prevention (CDC) and local authorities.
and Moderna plans to provide the vaccine to any trial participant who requests a vaccination.
while most experts tend to maintain blindness and placebo control, the Pfizer program is more approved of the Pfizer program than the One program for the placebo group.
Goodman, associate dean of clinical and translational studies at Stanford University School of Medicine, took a more in-depth look at the compromise recommendations made at last week's expert meeting on maintaining a placebo-controlled design after vaccine authorization.
his alternative clinical trial design is simply to invite all volunteers in the Moderna clinical trial to be injected twice more, the placebo recipient will be vaccinated, and the vaccine recipient will receive the placebo.
this will allow for the collection of more data, particularly on the persistence of vaccine benefits.
, but last week Pfizer representatives said the alternative was impractical and that "44,000 more subjects must be treated twice."
letter to the trial participants, Moderna wrote, "If you find yourself receiving a placebo, we plan to provide you with the opportunity to receive the mRNA-1273 vaccine and continue your research."
we expect to begin delivering the mRNA-1273 vaccine approximately 1-2 weeks after it is obtained by EUA.
Tal Zaks said volunteers receiving placebos would not "team up" when vaccinated because they would receive vaccines earmarked for clinical trials rather than commercial use.
moderna believe vaccines should be made available to more placebo patients as soon as possible.
, a researcher at Bregan Women's Hospital in Michigan and one of the lead researchers on the Moderna vaccine study, described Moderna's plan to provide vaccines to placebo patients.
his comments suggest that many of the FDA's desire to maintain a placebo control is unreasonable.
, he said , " it is important that we seriously consider the views of volunteers . "
without them, clinical studies would not work.
" volunteers, including many health care workers who may be eligible for the Pfizer/BioNTech vaccine, have begun voting with their feet and withdrawing from the study.
that the volunteers were recruited for the Moderna study precisely because they were highly susceptible to COVID-19 diseases and complications.
Baden said he was the co-author of an earlier paper by Stanford University's Steven Goodman on double-blind cross-cutting, but it was too late to put the design into practice.
the problem is that it's not practical at the moment, and if we lose volunteers, our ability to learn more about any information is greatly diminished, ' says Baden, a volunteer.
, deputy director of the FDA's Vaccine and Related Products Application Division for Allergic Reactions, noted an allergic reaction among medical staff in Alaska on Wednesday.
followed reports of two allergic reactions in the UK last week.
all of these cases were after Pfizer was vaccinated.
said the FDA expects more reports of allergic reactions to vaccines and will investigate if they occur.
He told the panel that
Anthough the total data at this time continues to support Pfizer's EUA vaccinations and do not require new restrictions, these cases highlight the need to be vigilant in the early stages of vaccination."
" FDA is working with Pfizer to update the fact books and prescription information pages for vaccines to highlight guidance on post-vaccination monitoring and allergic reaction management, and to emphasize the need for rapid treatment in the event of an allergic reaction.
said that if Moderna's vaccine were to be used under the EUA, it would do the same for its vaccine.
Modelna executives told the panel that the company has conducted Phase 1 and Phase 2 trials of 12 mRNA vaccines for eight other pathogens over the years, which recruited a total of about 17,000 participants.
these experimental vaccines use the same vaccine platform and similar ingredients as the Moderna COVID-19 vaccine.
Mark Sawyer, a professor of clinical pediatrics at the University of California, San Diego, asked if Moderna had reviewed the early trial data to see if there were reports of allergic reactions among the participants.
, head of the Department of Infectious Diseases at Moderna, told the panel that Moderna had conducted a rapid review of the data.
a report on an allergic reaction in a woman with a history of soy allergies.
she developed an allergic reaction two months after vaccination, and the allergic reactions caused by vaccination became rapid, so the condition is likely to be unrelated to vaccination.
Moderna's chief medical officer, Tal Zaks, noted that the lipid nanoparticles used in the Moderna vaccine are not the same as those used in the Pfizer vaccine, and he doesn't think they have the same likelihood of causing allergic reactions or other side effects.
the vaccine by using lipid nanoparticles to wrap mRNA to protect it from degradation before entering cells and triggering an immune response.
face swelling after vaccination may have been caused by a previously injected beauty needle? Introducing the FDA's analysis of The Moderna data to the panel, FDA Medical Officer Rachel Zhang noted that the report showed that two people had a swollen face after vaccination, both of them having a history of cosmetic injections of leather fillers on their cheeks.
received facial fillers two weeks before vaccination and another about six months before vaccination.
third person in the Moderna trial group developed swelling of blood vessels in the lips about two days after vaccination.
said the man had previously injected leather fillers into his lips.
said, "The subject reported a similar reaction after previous flu vaccinations."
all three cases, swelling is restricted and subsides on its own after treatment with antihistamines or steroids.
zhang said the FDA team conducted a literature review and found earlier reports that people who injected leather fillers had temporary swelling as a result of vaccinations.
"We plan to explain this in the prescription information.
" Moderna vaccine prevents the spread of the virus in addition to symptomatic diseases? What happened to the 11 subjects who still had COVID-19 disease after being vaccinated? The answer is simple: no one knows yet.
, who called Modelna, said the company was still collecting and analyzing key data, which could not be ready until next month.
11 so-called breakthrough COVID-19 cases are particularly critical for Paul Offit, a virologist at Children's Hospital of Philadelphia and a member of the panel.
if it turns out that these patients have significantly lower levels of mesoth antibodies than those who were vaccinated but not infected, they can help establish the baseline immune response needed to prevent infection.
for now, no one can determine which level of antibody is needed to prevent COVID-19.
similar, said Patrick Moore, a virologist at the University of Pittsburgh School of Medicine, the 11 volunteers may help understand how SARS-CoV-2 may mutate.
if they are found in the study to be genetically different from other viruses, it could indicate that SARS-CoV-2 could evolve to avoid vaccination, which would be alarming.
currently has five notable variants of the virus.
Miller says they need to wait for answers to these questions because Moderna has not performed the necessary swabs, serological tests, and sequencing to answer these important questions.
more case data for all vaccine clinical trials, more data will be collected after the study is formally completed, and for The Moderna study, the data that is still being collected appears to be particularly large.
analysis of the current Moderna study includes 196 cases of symptomatic COVID-19.
to the panel's questions, Miller, of Moderna, said more than 450 cases were still going through the determination process, meaning researchers were reviewing all records before analyzing the data.
will triple the number of cases studied.
-Aspen