Covid-19 roundup: Moderna submits vaccine for full approval; WHO unveils new Greek-based system for naming variants
Moderna has initiated its BLA submission process with the FDA to license its Covid-19 vaccine in adults 18 and older, the company announced Tuesday.
The company will submit data on a rolling basis with a request for priority review, Moderna said. Currently, the jab is available under EUA. And the submission comes amid survey data suggesting more Americans may take a vaccine that is formally approved by the FDA, rather than available under emergency use.
“We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application of our COVID-19 vaccine,” said CEO Stéphane Bancel. “We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission.”
To avoid a mouthful of numbers and reduce stigma, the WHO turns to Greek alphabet for variants
In hopes of simplifying the names of Covid-19 variants, the World Health Organization announced a new system for naming them on Monday. Variants will be given a name from the Greek alphabet, in an effort to both simplify the discussion and remove stigma from the emergence of new variants.
The goal is to ensure countries are less hesitant to report a new variant, so long as health officials know that it won’t be named after the country. B.1.1.7, formerly known as the British variant, will now be known as Alpha, and the South African B.1.351 will be called Beta.
If all 24 letters of the Greek alphabet are used, then another similar series will be announced, coronavirus head Maria Van Kerkhove said. For a short while, the group considered using names of Greek gods and goddesses, and numbering them 1, 2 and 3. Originally, the plan was to create 2-syllable names that aren’t words, STAT reports. The Greek alphabet eventually was approved by a group that shared the same members as the group that changed SARS-CoV-2 to Covid-19.
The WHO will keep a list of variants on its website.
WHO validates Chinese vaccine for emergency use
The WHO on Tuesday validated Beijing-based Sinovac’s Covid-19 vaccine, known as CoronaVac, for emergency use, giving countries, funders, procuring agencies and communities the assurance that it meets international standards for safety, efficacy and manufacturing.
WHO’s Emergency Use Listing is a prerequisite for COVAX Facility vaccine supply and international procurement. It also allows countries to expedite their own regulatory approval to import and administer Covid-19 vaccines. The WHO said its assessment included on-site inspections of the production facility.
CoronaVac product is an inactivated vaccine, and its storage requirements make it very manageable and particularly suitable for low-resource settings, WHO said.
DSMB passes CureVac jab but no data yet
CureVac’s Phase IIb/III study has passed early safety check from the Data Safety Monitoring Board, the company announced Friday. But the company did not announce efficacy data and highlighted the “variant-rich environment” surrounding the study, raising questions about just how much protection the vaccine offers.
CureVac did not have access to trial data, and it will continue to be collected to determine efficacy, the company said in a release. There was hope that this announcement would make trial data public, but the company said last week that more data will become available by the end of June.
The trial is conducted in an environment “characterized by the spread of multiple virus strains,” the press release said, though it did not elaborate. Three quarters of the study’s participants are in Latin America, where the P.1 variant — now called Gamma — has spread.
A week ago, the FDA said that for the rest of the pandemic, it may decline to review and process further EUA requests for Covid-19 vaccines unless a developer has already engaged with the agency. That could cause an extra step for CureVac, and force the company to submit its full BLA to the FDA.
Novartis paired with CureVac in early March to aid manufacture the bulk drug substance for the vaccine, but the company may have missed the boat in both the US and the EU.
The study involves 40,000 participants in 10 countries in Latin America and Europe, with 75% from Latin American and the remaining 25% from Europe. The 2-dose jab, mRNA is being tested in patients who have not had prior exposure to Covid-19.
Fauci emails from last year reveal how he was inundated with requests
The Washington Post obtained 866 pages of emails from Anthony Fauci, the the longtime director of the NIH’s National Institute of Allergy and Infectious Diseases, while he was “struggling to bring coherence to the Trump administration’s chaotic response to the virus” last year.
The emails show how Fauci received about 1,000 messages per day from colleagues, hospital administrators, foreign governments and random strangers — “writing to seek his advice, solicit his help or simply offer encouragement.” A documentary on Fauci is set to be released later this year and one email said that Robert Iger, executive chairman of Walt Disney, “was immensely supportive” of the documentary, which may feature footage discreetly shot as the doctor went about his pandemic duties.
Other internal emails from the Trump administration showed similar requests made to other officials.
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