EUA

The Russian invasion of Ukraine caused European carbon credit prices to plummet sharply. They are recovering, but these factors will weigh on future demand.

In September 2020, regulators asked for extra safety data on the new mRNA vaccines. The human cost of that request is far from clear.

Pfizer and BioNTech said on Tuesday they're seeking emergency use authorization from the US Food and Drug Administration for a COVID-19 vaccine booster for all individuals age 18 and older.

Pfizer and BioNTech said on Tuesday they're seeking emergency use authorization from the US Food and Drug Administration for a COVID-19 vaccine booster for all individuals age 18 and older.

Advisors to the U.S. Centers for Disease Control and Prevention are recommending Pfizer’s two-dose COVID-19 vaccine be made available to children 5 to 11 years old. As it stands, only those 12 and older are authorized to get a Pfizer vaccine. More than 5.5 million Michigan residents have gotten a COVID-19 vaccine as of Tuesday, Oct. 26, including more than 3 million who received a Pfizer shot. To find a vaccine near you, eligible residents can visit Michigan’s COVID-19 vaccine website or go to VaccineFinder.org. Read more on MLive:4 ways vaccinating younger children for COVID-19 could be a game-changer592 infected across 101 new COVID-19 outbreaks at Michigan schoolsWho is left to be vaccinated against COVID-19, and why is it the toughest task yet?

Police and witnesses in Japan say a man brandishing a knife on a Tokyo commuter train car stabbed several passengers before setting a fire, sending people scrambling to escape. The Tokyo Fire Department said 17 passengers were injured. (Oct. 31)

It’ll now be up to the FDA now to decide whether to grant Johnson & Johnson’s application for EUA. Before the vote, members of the Vaccines and Related Biological Products Advisory Committee received a presentation of data from Johnson & Johnson’s clinical trials. During the discussion that followed, a number of members said the Johnson & Johnson vaccine should likely have been a two-dose vaccine from the start and should be moving forward. The FDA first granted an EUA for the single-dose Johnson & Johnson vaccine February 27. To find a vaccine near you, visit Michigan’s COVID-19 vaccine website or go to VaccineFinder.org.

The Food and Drug Administration’s (FDA) vaccine advisory panel is set to meet Thursday and Friday, Oct. 14-15, over Moderna and Johnson & Johnson booster shots.

It’s a move that has been highly anticipated by pediatricians and many parents as coronavirus cases have risen in that age group.

Children are one step closer to being eligible for a COVID-19 vaccine. On Thursday, Oct. 7, Pfizer and BioNTech officially submitted their request to the U.S. Food and Drug Administration for emergency use authorization (EUA) of its COVID-19 vaccine in children 5 to 12 years old. Additional trials are underway with children younger than 5, and those results are expected to be shared later this year. To find a vaccine near you, visit Michigan’s COVID-19 vaccine website or go to VaccineFinder.org. Johnson & Johnson requests FDA authorization for a COVID booster shot400 employees resign, while 99% comply with Henry Ford Health System’s COVID-19 vaccine mandate

Pfizer and BioNTech have officially submitted a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization of their COVID-19 vaccine for children aged 5 to 11.

The claim is that the FDA didn't really fully approve the Pfizer vaccine. It's based on misinformation.

The vaccine even got a new name, too.

At the current pace, a vaccine for children ages 5 to 11 won't be available until early 2022. Here's how the FDA could make it happen more quickly.

Full approval of Pfizer or Moderna's vaccines will embolden employers to mandate the shots and the companies to advertise on TV.

The CDC’s independent advisory committee is recommending use of Pfizer’s two-dose COVID-19 vaccine for individuals 12 to 15 years old. “Providers across Michigan are preparing to open their vaccine clinics to kids aged 12 to 15 as soon as tomorrow. The vaccine was 100% effective in preventing COVID-19 in the vaccinated participants. In addition to discussing the safety and effectiveness of Pfizer’s vaccine in younger recipients, the advisory committee also noted that the CDC has removed its previous recommendation not to administer the COVID-19 vaccine within 14 days of any other vaccines. Substantial data has since been collected to determine it’s safe to co-administer the COVID-19 vaccines with other shots.

On Monday, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. The FDA amended the EUA originally issued on Dec. 11, 2020 for administration in individuals 16 years of age and older.

"If authorized, we're ready to roll out this vaccine without delay." A senior administration official told CNBC on Tuesday that states will be given 2 million doses if authorized. Earlier on Wednesday, FDA staff endorsed J&J's vaccine for emergency use. The Biden administration has gradually increased the number of doses it allocates to states each week. The U.S. has delivered more than 82 million doses of Covid-19 vaccines so far, and has administered just over 65 million of them, according to recent data from the Centers for Disease Control and Prevention.

In a rare weekend press conference, the U.S. Food and Drug Administration (FDA) -- who is responsible for authorizing widespread use of Pfizer’s coronavirus vaccine on Friday -- discussed some of people’s biggest concerns about the vaccine. Amid two recent cases of allergic reactions to Pfizer’s coronavirus vaccine in the U.K., FDA officials addressed concerns about individuals with a history of allergic reactions receiving the vaccine. FDA officials said Saturday that they’ve followed that process when reviewing Pfizer’s vaccine, and they feel confident that it is safe for this age group to receive the shots. During Saturday’s news briefing, officials made it clear that pressure from the White House did not force the FDA to authorize use of the vaccine too early. More: Report: White House to FDA chief: Approve Pfizer vaccine Friday or quit“We’re going to maintain the integrity of the scientific process,” Hahn added.

AdvertisementDuring a public health emergency, it’s imperative to develop new medicines and vaccines as quickly as possible. AdvertisementFor starters, the country needs to be in an official, specific kind of public health emergency. Secretary of Health and Human Services Alex Azar declared that the coronavirus triggered a nationwide public health emergency that began on Jan. 27, but that declaration doesn’t count because it was issued under the Public Health Service Act. Azar issued a public health emergency under this law that was effective as of Feb. 4. An EUA can last only as long as a public health emergency is in effect.

The data reviewed also suggests that the two-dose vaccine may begin preventing some COVID-19 cases after the first dose, though more conclusive data is still needed. This early analysis by FDA reviewers of data submitted by Pfizer seems to be a positive step towards that. A panel of outside experts will meet on Thursday to give the FDA its recommendations based on a cost-benefit analysis. The FDA is following its tough advisory committee process because of the sheer scale of the vaccine distribution program. On Tuesday, Dec. 8, Margaret Keenan, 90, of Northern Ireland, became the first person in the world to receive a clinically authorized, fully tested COVID-19 vaccine.

Roche received emergency use authorization (EUA) from the U.S. Food and Drug Administration for a new test that measures coronavirus antibodies within the blood. The Swiss diagnostics and pharmaceutical giant said Wednesday that the test, called "Elecsys Anti-SARS-CoV-2 S," specifically detects antibodies against the virus' spike protein within blood samples. It appeared to be positioning its tests as a way to gauge individuals' antibody response to coronavirus vaccines that could soon become widely available, noting that "many current candidate vaccines aim to induce an antibody response against the coronavirus spike protein. Tests that quantify antibodies to the spike protein could be used to measure the level of that response and track that measurement over time." "Antibody tests like these will play a critical role in measuring a person's vaccine-induced immune response," he added.