Show Notes
Moderna Receives U.S. FDA Approval for RSV Vaccine mRESVIA(R)
May 31, 2024
Moderna, today announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345),
an mRNA respiratory syncytial virus (RSV) vaccine,
to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.
The approval was granted under a breakthrough therapy designation and marks the second approved mRNA product from Moderna.
Stéphane Bancel, Chief Executive Officer of Moderna.
The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform
Moderna expects to have mRESVIA available for eligible populations in the U.S. by the 2024/2025 respiratory virus season.
Moderna has filed for mRNA-1345 approval with regulators in multiple markets around the world.
Moderna races ahead in flu and Covid-19 combo vaccine race with Phase III win
Moderna injection mRNA-1083
Comprises a seasonal influenza vaccine candidate, mRNA-1010,
and a next-generation Covid-19 vaccine prospect called mRNA-1283.
Moderna announces positive data from a Phase III trial of its mRNA vaccine candidate.
Now, in a Phase III trial (NCT06097273) for mRNA-1083
Moderna
“statistically significantly higher immune responses” compared to existing vaccines on the market.
The trial met its primary endpoints, Moderna said in a 10 June press release.
Immune response was seen across three influenza virus strains (H1N1, H3N2, and B/Victoria) and against SARS-CoV-2.
Although Moderna has not published the full dataset from the Phase III trial,
it plans to present the results in more detail at an upcoming medical conference,
in addition to a submission for publication.
The company said it “will engage with regulators on next steps”.
Other mRNA vaccines in development
Moderna Advances Multiple Vaccine Programs to Late-Stage Clinical Trials
Cytomegalovirus (CMV)
CMVictory is a pivotal Phase 3 trial evaluating mRNA-1647 against primary CMV infection in women 16 to 40 years of age.
Epstein-Barr virus (EBV)
mRNA-1189
The randomized, observer-blind, placebo-controlled study is fully enrolled.
Herpes simplex virus (HSV)
mRNA-1608
Phase 1/2 trial
The randomized 1:1:1:1, observer-blind, controlled study is fully enrolled with 300 participants in the U.S.
Varicella-Zoster virus (VZV)
Moderna's VZV vaccine candidate mRNA-1468 has initial data available from a Phase 1/2 trial
Norovirus
The Company is advancing mRNA-1403 toward a pivotal Phase 3 trial. Learn more about your ad choices. Visit megaphone.fm/adchoices
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Open access using this link:Uploaded 13-12-23https://onlinelibrary.wiley.com/doi/10.1111/eci.14136Effectiveness of a fourth SARS-CoV-2 vaccine dose in previously infected individuals from AustriaEvidence is limited on the effectiveness of a fourth vaccine dose against coronavirus disease 2019,in populations with prior SARS-CoV-2 infections. We estimated the risk of COVID-19 deaths (primary outcome)We estimated the risk of SARS-CoV-2 infections (secondary outcome)MethodsAustria nationwide retrospective observational study. 1 November to 31 December 2022Primarily comparing individuals with four versus three vaccine doses. Whole population data.Results3,986,312 previously infected individuals281,291 (7,1%) had four vaccinations at baseline1,545,242 (38.8%) had three vaccinations at baseline We recorded69 COVID-19 deaths89,056 SARS-CoV-2 infectionsThe majority of COVID-19 deaths and a significant proportion of all-cause deaths occurred in nursing home residentsRelative vaccine effectiveness (rVE) for four versus three vaccine doses-24% against COVID-19 deaths17% against SARS-CoV-2 infections. Protection against infection rapidly diminished over time,and infection risk with four vaccinations was higher during extended follow-up until June 2023. Adjusted HR for all-cause mortality for four versus three vaccinations was 0.79.That is people with a 4th dose were only 79% as likely to die(Suggesting healthy vaccinee bias, i.e. healthier persons received more vaccine doses)DiscussionIn previously infected individuals, a fourth vaccination did not reduce COVID-19 death risk, but with transiently reduced risk of SARS-CoV-2 infections,and reversal of this effect in longer follow-up. All-cause mortality data suggest healthy vaccinee bias.More detailsMostly Pfizer vaccine, some ModernaIn this study, overall case fatality rate, 0.08%.(IFR, ? 0.008% if 10% of infections picked up)Individuals with repeated previous infections had reduced re-infection riskNatural immunity may be a main determinant of immunological protection in a populationBy end 2022, the vast majority of the global population had already acquired some immune protectionCompared to three vaccine doses, those with fewer or no vaccinations did not differ with regard to COVID-19 mortality,but had reduced risk of SARS-CoV-2 infections.In 2022, infection fatality rates due to SARS-CoV-2 significantly declined suggesting transitioning into endemicity.In general, our study results question whether recommendations for repeated vaccine boosters against SARS-CoV-2 are currently justified for large parts of the general population with a history of previous infections. Measures against SARS-CoV-2 including vaccine policy should be critically re-assessed for their risk-to-benefit ratio.As most SARS-CoV-2 infections are asymptomatic or mild in an endemic phase, effectiveness of vaccinations should be primarily evaluated according to hard clinical outcomes (e.g. COVID-19 deaths)Extended follow-upFrom 1 January to 30 June 2023Omicron XBB.1.5. was the predominant variant225 COVID-19 deaths174,174 SARS-CoV-2 infections. Analyses in 2023 confirm no relative vaccine effectiveness (rVE) for four versus three vaccine doses for COVID-19 mortality,but show higher risk of SARS-CoV-2 infections with a rVE of −17%Free download John’s textbooks in high res pdf.https://drjohncampbell.co.ukCheck out Campbell's Physiology Notes Dr John Campbell Sold by author on eBay!https://www.ebay.co.uk/itm/155780745424?mkcid=16&mkevt=1&mkrid=711-127632-2357-0&ssspo=K6raxMZrQnm&sssrc=4429486&ssuid=K6raxMZrQnm&var=&widget_ver=artemis&media=EMAIL Learn more about your ad choices. Visit megaphone.fm/adchoices Learn more about your ad choices. Visit megaphone.fm/adchoices
Virus being experimented on in China. https://www.researchgate.net/publication/377199018_Lethal_Infection_of_Human_ACE2-Transgenic_Mice_Caused_by_SARS-CoV-2-related_Pangolin_Coronavirus_GX_P2Vshort_3UTR
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