Showing the potential for asymptomatic infection FDA releases detailed data on Moderna's new crown vaccine

FDA scientists say mRNA-1273 shows good protective effectiveness and safety.
similar to last week's analysis of BNT162b2, Pfizer's/BioNTech's new crown vaccine, the mRNA-1273 vaccine showed protective effect about 14 days after the first vaccination.
it's worth noting that the latest data from Moderna suggest that mRNA-1273 may also have a good effect in preventing asymptomatic infections, which can have a significant impact on controlling the spread of the new coronavirus.
mRNA-1273 Protective COVID-19 Pot in the protection of symptoms of COVID-19, the final analysis showed that mRNA-1273 effectiveness reached 94.1%, in 18-65 years of age, the protective effect of 95.6%, in participants over 65 years of age, protection effectiveness of 86.4%.
among subjects at risk of developing severe COVID-19 due to underlying cogeneration (including obesity, chronic lung disease, heart disease, diabetes, liver disease, HIV infection), mRNA-1273 achieved 95.9% protection effectiveness, comparable to that of the population as a whole.
in the prevention of severe COVID-19, mRNA-1273 achieved 100% protective effectiveness, and a total of 30 patients with severe COVID-19 were found in clinical trials, all from the control group. An analysis of the accumulation curve of COVID-19 cases in the
vaccine group and control group COVID-19 patients (photo source: Reference: 1) showed significant differences in the accumulation curve of COVID-19 cases in the control group and the vaccine group about 14 days after the first vaccination of mRNA-1273.
analysis showed that mRNA-1273 was 80.2 per cent protected between the first and second doses (28 days apart).
because it still takes some time for the body to develop an immune response after vaccination, the researchers calculated the incidence of COVID-19 within 14 days of first vaccination and 14 days after vaccination.
results showed that the vaccine was 50.8 percent effective within 14 days of first vaccination, and 92.1 percent after 14 days of vaccination.
this protective effect is very close to that achieved by two doses of the vaccine.
the efficiency of protecting COVID-19 after a first vaccination (Photo Source: Reference 1) But the researchers note that there is not enough evidence to prove that a one-time inoculation provides protection for more than 28 days.
mRNA-1273 to protect against asymptomatic infections In addition to protecting against symptomatic COVID-19, the ability of the new crown vaccine to protect against asymptomatic infections is also an important concern.
coVID-19, which protects against symptoms, means that the severity of COVID-19 can be reduced, but patients infected with the new coronavirus may still be able to transmit the new coronavirus to others.
if the new corona vaccine can prevent asymptomatic infections, they have the potential to prevent the continued spread of the new coronavirus, thereby more effectively controlling the development of the COVID-19 outbreak.
in an appendix provided by Moderna to the Advisory Committee on Vaccines and Related Biological Products, Moderna said that at the time of submitting an application for authorization for emergency use, the researchers had not yet obtained the results of an analysis of the protection against asymptomatic infections as set out in the clinical trial program.
, however, the researchers collected nasopharyngeal swab samples from participants before the first vaccination and before the second vaccination and assessed whether the samples carried the new coronavirus.
descriptive summary showed that among participants who tested negative for neo-coronavirus nucleic acid before the first vaccination, samples from 14 people in the vaccine group showed new coronavirus infection before the second vaccination, compared with 38 in the control group.
participants did not show COVID-19 symptoms.
, the number of new coronavirus-positive samples in the vaccine group was two-thirds lower than in the control group after the first vaccination.
means that mRNA-1273 is beginning to show results in protecting against asymptomatic infections after the first vaccination.
prior to the second dose of the vaccine, data from asymptomatic new coronavirus infections judged by nucleic acid testing (Photo source: Reference 2)) assess the safety of the vaccine The mRNA-1273 showed good safety and tolerance in terms of safety.
local adverse reactions are pain at the injection site and swelling and pain in the armpits.
systemic adverse reactions were fatigue (68.5%), headache (63%) and muscle pain (59.6%).
14.8 per cent of vaccinators developed fever symptoms, especially after the second dose (15.6 per cent).
in serious adverse events, FDA evaluaters noted that three adverse events may be vaccine-related.
included one case of stubborn nausea and vomiting, and two cases of facial swelling.
two cases of facial swelling underwent cosmetic injections six months before vaccination.
say this may be an inflammatory response caused by the interaction between the vaccine-inspired immune response and the fillers in beauty injections.
advisory committee will discuss the emergency use authorization for moderna's new crown vaccine on 17 December.
the experience of BNT162b2, developed jointly by Pfizer/BioNTech last week, and this week we are expected to welcome the second FDA-approved new crown vaccine.
let's wait and see.
: s1. Vaccines and Related Biological Products Advisory Committee Meeting, December 17, 2020, FDA Briefing Document, Moderna COVID-19 Vaccine. Retrieved December 15, 2020, from [2] Vaccines and Related Biological Products Advisory Committee Meeting Presentation. Retrieved December 15, 2020, from