Late yesterday Johnson & Johnson submitted a request for an emergency use authorization (EUA) for its COVID-19 candidate. If the EUA is granted by the Food and Drug Administration (FDA), the vaccine will become the third COVID-19 vaccine approved for use in the United States, and the first that requires only one dose.
Last week Johnson & Johnson released results from a phase 3 trial of the drug that showed an overall efficacy rate of 66%. The vaccine, however, was more than 85% effective in preventing severe illness from COVID-19 infections and 100% effective in preventing hospitalizations and deaths.
"Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping," said Paul Stoffels, MD, the chief scientific officer for Johnson & Johnson in a press statement.
"With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible."
FDA experts to meet Feb 26
If approved, the vaccine may be ready for use in the United States by the end of March. Through Operation Warp Speed, Johnson & Johnson has a contract to fulfill 100 million doses of vaccine in the coming year. Last year, the FDA said it would likely approve any vaccine that proved to be more than 50% effective against the novel coronavirus.
In light of the request, the FDA scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee for Feb 26 to vote on the EUA.
In related news, yesterday the FDA Acting Commissioner, Janet Woodcock, MD, announced that the Biden administration would release new draft guidance concerning vaccine, drugs, and tests targeted towards the emerging variants of COVID-19.
According to Politico, the FDA is looking at an influenza model for handling COVID-19 vaccination going forward, meaning booster shots would be manufactured yearly to target circulating strains.
Lawmakers call for vote on vaccine package
Capitol Hill lawmaker from both sides of the aisle are calling for a vote on a $160 billion COVID-19 vaccine distribution package, The Hill reports. The money would go immediately toward vaccine distribution plans. The bill includes, among other allocations, $20 billion for the National Vaccine Program’s partnership with states, tribes and territories, $50 billion for expansion of testing, and $30 billion for disaster relief.
The money would be allocated immediately, regardless of the status of a Biden administration COVID-19 relief bill.
The Centers for Disease Control and Prevention (CDC) COVID Data Tracker shows 57,489,675 COVID-19 vaccines doses have been distributed in the country and 35,203,710 doses have been administered.
Today during a COVID-19 task force press briefing, Tim Manning, supply coordinator for the COVID-19 Response Team, said the Defense Production Act had been invoked to help Pfizer get the materials it needs to boost vaccine production.
More home testing promised
In addition to vaccine supply chain, Manning said the United States would sign contracts with six more companies producing at-home rapid COVID-19 tests that could flood the US market by this summer.
"The country is well behind where we need to be in testing," Manning said.
The tests, Manning said, are a key component of retuning the United States back to a level of pre-pandemic normalcy. Earlier this week, the White House team said it had signed a $231.8 million contract with Ellume, an Australian manufacturer of a 15-minute home-based COVID-19 test.
Mask mandates possibly tied to fewer cases
Two new studies led by CDC researchers today indicated that mask mandates might yield benefits, with one linking the measure to reduced hospitalizations and the other showing good compliance on college campuses. Both studies appeared in Morbidity and Mortality Weekly Report (MMWR).
In the hospitalization study, CDC researchers and their partners in 10 COVID-NET surveillance states that had mask mandates compared COVID-19 growth rates before and after the mask order took effect.
They found a 5.5-percentage-point decline in weekly hospitalizations for COVID-19 in adults ages 18 to 64 years old after mandates were ordered, compared with the 4 weeks before the measure began. When they looked at timing, they found a statistically significant decline in people ages 40 to 64 less than 3 weeks after the mask mandate began, but for the 18 to 64 population that level was reached 3 or more weeks after the measure started.
The findings support other studies that suggest distancing measures, including masks mandates, were associated with immediate declines in coronavirus case increases, the team wrote, noting that costs for COVID-19 hospitalization can range from $8,400 in a general ward to $50,000 for intensive care unit (ICU) care with a ventilator.
The authors note, however, that their estimates don't control for other policies that may have helped drive down cases, such as school closings and physical distancing recommendations.
Mask-wearing is part of a multipronged evidence-based strategy for preventing virus transmission that have the potential to reduce strain on the healthcare systems, likely reducing severe illness and death, the team wrote.
In the second study, CDC and other US researchers observed mask use at six college campuses that had mask mandates from September to November, indoors and outdoors, as well as on and off campus. In indoor settings, the team found high compliance, with 91.7% wearing masks correctly.
Use in off-campus indoor settings was also high, at 90.6%. Correct mask use varied by type and was highest for N95 respirators and cloth facemasks and was somewhat lower for other types, such as bandanas and scarves.
Mask use outdoors, recommended when social distancing wasn't possible, was less common, at 67.6%. The team said direct observation provides rapid feedback that colleges can use to tailor training and messaging for correct mask use.
More than 600 variant B117 cases
Officials reported 119,931 new US COVID-19 cases yesterday and 4,941 deaths, according to the Johns Hopkins COVID-19 tracker. There are 88,668 COVID-19 patients in US hospitals, according to the COVID Tracking Project.
In total, the United States has seen 26,763,861 COVID-19 cases, including 458,037 deaths.
Of those cases, at least 611 are from the B117 variant, which has now been confirmed in 33 states, according to the CDC variant tracker. The CDC also noted five B1351 variant cases in two states, and two P1 variant cases in one state.
"emergency" - Google News
February 06, 2021 at 04:45AM
https://ift.tt/3jtVU1t
J&J COVID vaccine heads to FDA for emergency use decision - CIDRAP
"emergency" - Google News
https://ift.tt/2VVGGYQ
https://ift.tt/3d7MC6X
emergency
Bagikan Berita Ini
0 Response to "J&J COVID vaccine heads to FDA for emergency use decision - CIDRAP"
Post a Comment