A panel that advises the Food and Drug Administration (FDA) is set to meet this month to consider whether to recommend booster shots of the Moderna and Johnson & Johnson COVID-19 vaccines. The Vaccines and Related Biological Products Advisory Committee will meet on Oct. 14 and Oct. 15 to consider whether to recommend Moderna and Johnson…
US Drug Regulator Advisers to Meet on Moderna, Johnson & Johnson COVID-19 Vaccine Boosters
2nd Dose of Johnson & Johnson COVID-19 Vaccine Gives Stronger Protection, Company Says
A booster dose of Johnson & Johnson’s COVID-19 vaccine gives elevated protection against the virus that causes COVID-19, the company said Tuesday. Johnson & Johnson said data from a Phase 3 clinical trial its researchers are helping run showed that a second shot of its vaccine provides 75 percent protection against symptomatic COVID-19 globally, and…
FDA Extends Shelf Life of Johnson & Johnson’s COVID-19 Vaccine
The Food and Drug Administration (FDA) has agreed to extend the shelf life on Johnson & Johnson’s single-shot COVID-19 vaccine from four-and-a-half months to six months. In a July 28 concurrence letter (pdf), the FDA said Johnson & Johnson had provided sufficient data to support the extension of the company’s vaccine to six months, including…
Benefits of Johnson & Johnson COVID-19 Vaccine ‘Continue to Outweigh’ the Risk of Neurological Disorder: CDC Advisory Panel
The vaccine advisory panel to the Centers for Disease Control and Prevention (CDC) said on Thursday that the benefits of Johnson & Johnson’s COVID-19 vaccine still outweigh the risk of a serious, but rare, neurological disorder following vaccination. The Advisory Committee on Immunization Practices met to discuss the incidence of Guillain-Barré syndrome (GBS) following a…
CDC Investigating Cases of Neurological Disorder Linked to Johnson & Johnson COVID-19 Vaccine
The Centers for Disease Control and Prevention (CDC) has said that it’s investigating the possibility that Johnson & Johnson’s (J&J) COVID-19 vaccine can cause a rare neurological disorder known as Guillain-Barré syndrome (GBS). A spokesperson for the CDC told several news outlets on July 12 that the risk of developing the neurological disorder is very slim…
FDA to Add Warning About Neurological Disorder Linked to Johnson & Johnson COVID-19 Vaccine
The U.S. Food and Drug Administration (FDA) on Monday said it will add a warning label to Johnson & Johnson’s COVID-19 vaccine that it is linked to a rare neurological disorder known as Guillain-Barré syndrome (GBS), while J&J confirmed it is “in discussions” with federal agencies. “The FDA is announcing revisions to the vaccine recipient and…
J&J Agrees To Pay $230 Million To Settle New York Opioid Claim
NEW YORK—Johnson & Johnson has agreed to pay $230 million to New York state to settle claims that the pharmaceutical giant helped fuel the opioid crisis, Attorney General Letitia James said on Saturday. The drugmaker also agreed to permanently end the manufacturing and distribution of opioids across New York and the rest of the nation,…
Denmark Continues Exclusion of J&J, AstraZeneca COVID-19 Vaccines
COPENHAGEN—Health authorities in Denmark said on Friday that COVID-19 vaccines from AstraZeneca and Johnson & Johnson would remain excluded from the country’s vaccine roll-out following a review of new safety data. “The balance between possible benefit and possible harmful effects is still not favorable, even when we include assumptions in our analyses that benefit the…
FDA Authorizes More Doses of J&J CCP Virus Vaccine
The Food and Drug Administration (FDA) has authorized a new batch of the one-dose Johnson & Johnson CCP (Chinese Communist Party) virus vaccine. In a statement on Tuesday, the agency said it authorized a batch of the J&J vaccine made at a facility in Baltimore run by Emergent BioSolutions, bringing the total number of FDA-authorized J&J batches made…
US Extends Expiration Dates for J&J COVID-19 Vaccine by 6 Weeks
WASHINGTON—Johnson & Johnson said Thursday that U.S. regulators extended the expiration date on millions of doses of its COVID-19 vaccine by six weeks. The company said a Food and Drug Administration review concluded the shots remain safe and effective for at least 4 1/2 months. In February, the FDA originally authorized J&J’s vaccine for up…
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