Novavax Says Trials Show Its Covid Vaccine To Be Safe And 90% Effective
The vaccine manufacturer plans to apply for FDA clearance in the third quarter of this year. If authorized, it would be the fourth vaccine available in the U.S. And another coronavirus shot option would help boost global vaccination efforts.
CNBC:
Novavax Says Its Covid Vaccine Is 90% Effective, Plans FDA Submission In Q3
Biotech firm Novavax said Monday its Covid-19 vaccine was shown to be safe and 90.4% effective overall in a phase three clinical trial of nearly 30,000 participants across the United States and Mexico. Additionally, it said the two-dose vaccine was found to be 100% effective in preventing moderate and severe disease and 93% effective against some variants. The company said it plans to file for authorization with the Food and Drug Administration in the third quarter. (Lovelace Jr., 6/14)
AP:
Novavax: Large Study Finds COVID-19 Shot About 90% Effective
While demand for COVID-19 shots in the U.S. has dropped off dramatically, the need for more vaccines around the world remains critical. The Novavax vaccine, which is easy to store and transport, is expected to play an important role in boosting vaccine supplies in the developing world. That help is still months away, however. The company says it plans to seek authorization for the shots in the U.S., Europe and elsewhere by the end of September and be able to produce up to 100 million doses a month by then. (Johnson, 6/14)
NPR:
Novavax Says Its COVID Vaccine Is Extremely Effective
In addition to efficacy, the PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial COVID-19) trial showed the Novavax vaccine was safe for users. Like other COVID-19 vaccines, it caused headaches, chills and muscle aches after injection, but few of these side effects were considered serious or severe. The study involved 29,960 volunteers in the United States and Mexico. In the study, two-thirds of the volunteers received two shots of the vaccine and one-third received two shots of a placebo. (Palca, 6/14)
J&J Must Toss 60M Doses After Plant Contamination Incident
Following inspections at the Emergent BioSolutions plant in Baltimore, the Food and Drug Administration told Johnson & Johnson that 60 millions covid vaccine doses could be tainted and are unusable, The New York Times reports. No shots manufactured at the troubled facility have been administered in the U.S.
The New York Times:
F.D.A. Tells J.&J. To Throw Out 60 Million Doses Made At Troubled Plant
Federal regulators have told Johnson & Johnson that about 60 million doses of its coronavirus vaccine produced at a troubled Baltimore factory cannot be used because of possible contamination, according to people familiar with the situation. The Food and Drug Administration plans to allow about 10 million doses to be distributed in the United States or sent to other countries, but with a warning that regulators cannot guarantee that Emergent BioSolutions, the company that operates the plant, followed good manufacturing practices. (LaFraniere, Weiland and Gay Stolberg, 6/11)
The Hill:
Canada Rejects 300K J&J Vaccine Doses Made At Troubled Baltimore Facility
Canada has rejected 300,000 doses of the Johnson & Johnson vaccine from the U.S. after it was made at a Baltimore facility riddled with contamination issues. “Health Canada has completed its quality review of the shipment of Janssen vaccines that are currently in quarantine,” Health Canada announced on Friday. (Lonas, 6/12)
Fox News:
Fauci Pushes For Expanded COVID-19 Vaccination Among Adolescents
As coronavirus vaccines have become more widely available, officials are looking to expand COVID-19 vaccination coverage among adolescents. Speaking at a White House COVID-19 response team virtual town hall, Dr. Anthony Fauci, President Biden’s chief medical adviser, noted 3.3 million coronavirus infections and 314 deaths in those younger than 18. He also cited a recent report from the Centers for Disease Control and Prevention, which indicated low hospitalization rates among adolescents, at just two per 100,000 at the peak. Of the 204 children under study, nearly one-third were sent to an ICU and 5% required mechanical ventilation, however, there were no deaths. Also, 70.6% of the total had at least one underlying medical issue. (Rivas, 6/12)
Reuters:
U.S. Has Administered Over 309 Million Doses Of Covid-19 Vaccines, CDC Says
The United States had administered 309,322,545 doses of Covid-19 vaccines and distributed 374,398,105 doses in the country as of Sunday morning, the U.S. Centers for Disease Control and Prevention said. Those figures were up from the 308,112,728 doses of vaccine that the CDC said had been administered as of Saturday, out of 374,397,205 doses delivered. (6/13)
In other updates on the vaccine rollout —
CBS News:
CBS News Poll: Vaccinated Or Not, Americans Venture Out
In terms of who is out and about, vaccinated people tend to be comfortable, but non-vaccinated people — of whom there are still many — are just as comfortable, if not more so, going out to public places than those who are vaccinated. Those who say they won’t get the shot are more likely to be comfortable at a large event. (Salvanto, De Pinto an dBackus, 6/13)
The Washington Post:
Region Tries To Boost Coronavirus Vaccine Uptake Among Law Enforcement
As the Washington region’s coronavirus vaccination efforts continue, public health officials are homing in on segments of the population slow to get the shot — such as law enforcement officers. While no comprehensive surveying has been done in the region, Virginia officials say less than half of State Police troopers are vaccinated and about 50 percent of corrections officers in the state have been vaccinated. (Portnoy, 6/13)
Crain’s Detroit Business:
Family Doctors Dig In To Overcome COVID-19 Vaccine Hesitancy
Dr. Chris Bush, a veteran family physician in the Detroit suburb of Riverview, put out a call on social media recently. Under the modest Spanish tile roofed office building, a basic white kitchen refrigerator holds 90 doses of the Moderna COVID-19 vaccine. Once in hot demand — in March, eager people were driving hours to vaccine appoints and sometimes out of state — Bush struggles to find willing arms to place the shots. “We’re open to anyone in the public,” said Bush, a soft-spoken doctor who has practiced family medicine for more than 30 years. “We’re so blessed to have the vaccine and I’d hate to see it go to waste, but demand seems to have trickled off.” (Walsh, 6/13)
Houston Chronicle:
Mayor Sylvester Turner Spent Saturday Bar Hopping To Increase Houston’s Vaccination Rate
John Gipson sipped a margarita as he waited the necessary 15 minutes under the watchful eye of health workers after receiving the coronavirus vaccine. Gipson, 50, did so with the encouragement of Houston leaders, who are turning out at concerts and clubs to try to find people who still need the vaccines. That outreach Saturday included a grassy field in Acres Homes, steps from the Montgomery Road stops for Route 44 buses that give the community its “44” or “fo-fo” nickname. A Houston Health Department van and crew occupied a corner of the CAMZ Food Truck Park on opening day, as hundreds streamed in for an evening of concerts. Elected leaders took to the stage to celebrate the opening but also to boost vaccine numbers. (Begley, 6/13)
Mississippi Clarion-Ledger:
Mississippi Health Officials Push For More COVID-19 Vaccinations
As COVID-19 vaccination rates in Mississippi continue to stagnate, state health department officials are again encouraging more residents to roll up their sleeves to get the pandemic under control. State Health Officer Thomas Dobbs said that while infection and hospitalization levels have been declining for the past several weeks, variant strains still present a risk. “We still have people who are getting sick and dying,” he said. “But we are seeing some complacency.” (Rowe, 6/11)
NPR:
Anti-Vaccine Activists Spread Fear About COVID Vaccines With Selective Data
The largest U.S. database for detecting events that might be vaccine side-effects is being used by activists to spread disinformation about COVID-19 vaccines. Known as the Vaccine Adverse Event Reporting System (VAERS), the database includes hundreds of thousands of reports of health events that occurred minutes, hours or days after vaccination. Many of the reported events are coincidental — things that happen by chance, not caused by the shot. But when millions of people are vaccinated within a short period, the total number of these reported events can look big. (Brumfiel, 6/14)
