As the pendulum of vaccinating the world against COVID-19 begins to swing to developing countries, Moderna (NSDQ:MRNA) will build an mRNA facility in Africa that could produce as many as 500 million 50-µg vaccine doses annually. Its currently authorized booster has a 100-µg dose of mRNA, but the company aims to use a 50-µg dose…
How direct-to-patient can impact pharma supply chains
In the wake of COVID-19, telemedicine has become the only means for delivering patient care for many physician groups. As healthcare providers adapted to treating patients virtually, patients likewise adapted to disrupted routines. For those dependent on prescription medication to treat or manage a medical condition, “going to the pharmacy” was an errand replaced by…
EU committee backs Pfizer-BioNTech vaccine booster doses
Pfizer (NYSE:PFE) and BioNTech SE (NSDQ: BNTX) have received a positive opinion from the E.U.’s Committee for Medicinal Products for Human Use (CHMP) for the use of a Comirnaty booster dose in individuals at least 18 years of age at least six months after the second dose. The European Commission (EC) will likely make a formal decision on…
Why is the U.S. vaccination rate stalling?
In a recent press briefing, White House press secretary Jen Psaki touched on the flatlining COVID-19 vaccination rates in the U.S. Despite a series of vaccine mandates, the daily rate of new COVID-19 vaccinations is the lowest it’s been since mid-January, according to CDC data. Daily U.S. vaccination rates have dipped below 500,000 doses per…
Gottlieb: Delta wave could burn out by Thanksgiving
Pfizer board member Dr. Scott Gottlieb has predicted that the COVID-19 Delta surge could mark a high-water mark of the pandemic. “This may be the last major wave of infection,” said Gottlieb, who served as the FDA commissioner from 2017 to 2019. In an interview with CNN, Gottlieb predicted that the pandemic in the U.S.…
CDC director recommends boosters for more Americans
CDC Director Dr. Rochelle P. Walensky issued guidelines for COVID-19 boosters, clearing the way for tens of millions of U.S. citizens to obtain a third dose of the Pfizer-BioNTech COVID-19 vaccine. While FDA and the Advisory Committee on Immunization Practices (ACIP) reached broadly similar conclusions regarding booster doses for seniors and high-risk individuals, Walensky went…
FDA authorizes Pfizer boosters with caveats
The FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to allow a third dose in individuals who face a high risk of infection or developing severe COVID-19. Those groups include people at least 65 and those aged 18 to 64 with a high risk of developing severe COVID-19. The EUA also…
Single dose of Janssen’s COVID-19 vaccine offers durable protection, but a booster amplifies it
Drawing from de-identified insurance claims data, Johnson & Johnson (NYSE:JNJ) has announced that a single dose of its Ad26.COV2.S vaccine was 79% effective in preventing COVID-19 infections and is 81% effective in preventing hospitalizations associated with the novel coronavirus. The company also released results from its Phase 3 ENSEMBLE 2 trial, which tested the impact…
Report: U.S. set to buy hundreds of millions of Pfizer’s COVID-19 vaccine to share
The Biden administration reportedly plans to purchase and share with the world hundreds of millions of doses of Pfizer’s COVID-19 vaccine. The Washington Post reported today that the U.S. has plans to make another large purchase of COVID-19 vaccines, although details of the deal have not been made clear. Neither the White House nor Pfizer…
The details of Biden’s COVID-19 vaccine mandate remain unclear for many
President Biden’s announcement that the Labor Department will implement a COVID-19 vaccine mandate has sent shockwaves rippling through the country. In particular, the plan calls for employers with 100 or more employees to require full vaccination or undergo weekly testing. Conservative politicians balked at the notion of a vaccine mandate. Florida Governor Ron DeSantis has threatened…