Moderna says its vaccine shows durable 93% efficacy through 6 months, says it expects to complete FDA submission for full approval this month: investors.modernatx.com/news-releases/…
Moderna efficacy at final analysis (median follow-up 5.3 months):
Against COVID-19: 93.2%
Against severe COVID-19: 98.2%
Against death caused by COVID-19: 100%
(Note, this was before delta variant was circulating widely)
Moderna breaks down efficacy by 2-month segments post 2nd dose; says at month 4+, efficacy is 92.4%
(Pfizer says by months 4-6 its efficacy is 84% - though against severe disease maintains 97%)
Nonetheless, Moderna says it expects antibody levels will start to wane, and with delta there will be an increase in breakthrough infections in fully vaccinated; it sees need for boosters before winter:
Moderna says lab studies show a booster w half the dose of its #covid19 vaccine increases antibody levels against delta by 42-fold
Moderna reports top-line findings from phase 2 study of booster shot, noting neutralizing antibody titers had waned significantly by 6 months; safety profile of dose 3 was similar to that of dose 2
Here's what Moderna CEO Stephane Bancel said this AM when we asked on @SquawkCNBC if their 93% efficacy at 6 months is directly comparable to Pfizer's 84% (neither of these datasets included delta):
The @WHO's @DrTedros yesterday called for a moratorium on boosters until September to enable countries that haven't had vaccine access to be able to administer first shots. We asked Moderna's CEO how the company is responding to that call:
Pfizer research chief on quarterly earnings conf call just now: "We continue to believe it is likely that a third dose may be needed within six to 12 months of the full vaccination to maintain the highest level of protection." #covid19
Pfizer has contracts for 2.1B #covid19 vaccine doses in 2021, and plans to make 3B this year. CEO says on conf call just now co is in advanced discussions for many of the remaining doses and expects they'll all be allocated. Capacity for 2022 expected to be 4B doses.
Bernstein's Ronny Gal predicts an additional ~$10B in 2021 revenue for remaining #covid19 vaccine doses not yet contracted. Would mean $43.5B in total 2021 revenue from the Covid vaccine.
Pfizer plans to file for full approval of its #covid19 vaccine at the end of May, per its slide deck just posted for Q1 earnings. It now sees revenue from the vaccine this year of $26B. s21.q4cdn.com/317678438/file…
Pfizer plans to conduct study of pneumonia vaccine candidate w booster dose of #covid19 vaccine, w results expected in Q3 2021, in anticipation a potential booster of Covid vaccine will be authorized & recommended in US as early as fall/winter 2021: s21.q4cdn.com/317678438/file… (p13)
Pfizer plans to start phase 2/3 trial of oral antiviral for #covid19 in Q3, data in Q4, followed by EUA submission before year-end (presuming data are positive)
FDA says it concludes inspection of Emergent plant, issues 483 letter. Production of J&J vaccine remains stopped until issues are remediated. 483 letter here: fda.gov/media/147762/d…
FDA observations re Emergent plant:
1: Failure to conduct thorough investigations into unexplained discrepancies.
Specifically, cross-contamination of two viral vaccines. FDA: “there is no assurance that other batches have not been subject to cross-contamination.”
Note- FDA cites “cross-contamination of client [redacted] viral vaccine drug substance batch... with the virus from client [redacted].”
Emergent’s CEO April 1: “It wasn’t the case where an ingredient from one vaccine contaminated or impacted the other.”
-@aslavitt46: Nearly 1 in 5 adults and nearly half Americans 65+ have received first shot
.@aslavitt46: Biden Admin asking businesses to:
-require masking & social distancing to protect workers, customers
-reduce barriers to vaccination, provide incentives (paid time off, compensation)
-communicate w customers, educate public about benefits of masking & vaccination
.@aslavitt46 on business contribution:
🔹Ford and the Gap producing & donating millions of masks
🔹Pro sports & live events offered 100+ stadiums, venues for vaccination sites
🔹Retailers like Best Buy, Target, Dollar General gave 500K+ workers PTO or compensation to get vax
Moderna notes in earnings release this AM it's completed enrollment of its #covid19 vaccine study in kids ages 12-17 (study is called TeenCOVE); a phase 2 study in ages 6 months - 11 years (KidCOVE) will start "in the near-term" investors.modernatx.com/news-releases/…
Along w boosters of original vaccine & B.1.351-tailored vaccine, Moderna says it's developing a next-gen vaccine encoding for portions of the spike protein critical for neutralization (RBD & NTD). Shorter antigen & hoped to be fridge-stable. Plans to test as booster and primary.
Moderna details #covid19 vaccine supply deals:
US: 300M (option for 200M more)
EU: 310M (option for 150M in 2022)
Japan: 50M
Canada: 44M
Korea: 40M
UK: 17M
Switzerland: 13.5M
Colombia: 10M
Israel: 6M
Taiwan: 5M
Singapore: undisclosed
Qatar: undisclosed