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The ceaseless continues competition between anti-Covid vaccines. It’s hard to say who will finish the race first, given the continuous twists and turns these weeks, between Pfizer, Moderna and AstraZeneca (you can find our in-depth analysis on the differences here).
What the modern vaccine trial says
Moderna today announces new results considered extraordinary. The main efficacy analysis of the COVE phase 3 study of Moderna’s mRNA-1273, candidate for a Covid vaccine, involved 30 thousand participants in the United States and 196 cases of Covid-19, of which 30 serious cases.
Data analysis indicates a94.1% vaccine efficacy. Safety data continues to accumulate and the study continues to be monitored by an independent monitoring committee.
Efficacy was consistent across age, race, ethnicity, and gender demographics. The 196 Covid cases included 33 older adults (over 65) and 42 participants who identified as belonging to different communities, including 29 Hispanics or Latinos, 6 Blacks or African Americans, 4 Asian Americans, and 3 multiracial.
The primary endpoint of the Phase 3 COVE study is based on the analysis of confirmed Covid cases starting two weeks after the second dose of vaccine. The efficacy of the vaccine was demonstrated in the first interim analysis with a total of 95 cases.
Today’s analysis was based on 196 cases, of which 185 cases were observed in the placebo group, that is, not vaccinated, compared to 11 cases observed in the mRNA-1273 vaccine group, which increases the efficacy of the 94.1% vaccine. .
A secondary endpoint analyzed 30 severe cases of coronavirus. All 30 serious cases occurred in the placebo group. and none in the group vaccinated with mRNA-1273. To date, the study has produced just one death related to Covid, which occurred in the placebo group.
The effectiveness in severe cases of Covid
But the good news isThe efficacy against severe forms of coronavirus was even 100%.. A fundamental result, which opens up unthinkable scenarios until now.
The mRNA-1273 vaccine, the US drug company said, remains generally well tolerated. Till the date no serious safety issues were identified.
Based on previous analysis, the Adverse reactions common stresses included injection site pain, fatigue, myalgia, headache, erythema and redness at the injection site. Adverse reactions increased in frequency and severity in the 1273 mRNA group after the second dose.
The Phase 3 COVE study exceeded the 2-month post-vaccination follow-up required by the United States FDA for emergency use authorization, so much so that Moderna requested it today to enter the vaccine. on the market as soon as possible, proceeding with ongoing reviews, which have already been initiated with international regulatory agencies.
The company has already started the ongoing review process with EMA, Health Canada, SwissMedic, the UK Medicines and Healthcare Products Regulatory Agency MHRA, the Ministry of Health in Israel and the Health Sciences Authority in Singapore and looks forward to an emergency use by the World Health Organization.
Dosage, times and the agreement with Europe
By the end of this year, Moderna expects to have approximately 20 million doses of vaccines available in the United States. The goal is to produce 500 million to 1 billion doses globally in 2021.
As for Europe, as announced by the president Ursula von der Leyen, As part of the Union’s strategy for vaccines, the Commission has approved a sixth contract, precisely with the pharmaceutical company Moderna, after those of AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, BioNTech-Pfizer and CureVac.
The contract provides forinitial purchase of 80 million doses on behalf of all EU member states, with the option to request up to 80 million additional doses, to be provided as soon as the safety and efficacy of the vaccine are demonstrated.
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