Here’s what the FDA is saying about COVID-19 vaccines for young children as of Sept. 10, 2021
The Food and Drug Administration released the following statement Friday, Sept. 10, 2021 as COVID-19 makers are racing to submit clinical data seeking regulatory approval for vaccines in children younger than 12.
US expands use of Pfizer’s COVID-19 vaccine, paving way for children as young as 12 to get 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.
US tops 100M doses of COVID-19 vaccine in arms
FILE - In this Monday, Jan. 4, 2021 file photo, frozen vials of the Pfizer/BioNTech COVID-19 vaccine are taken out to thaw, at the MontLegia CHC hospital in Liege, Belgium. The European Commission has secured an agreement with Pfizer-BioNTech for an extra 4 million doses of COVID-19 vaccines to tackle a surge of coronavirus clusters that have prompted border restrictions. The doses are expected to be delivered before the end of March. (AP Photo/Francisco Seco, File)The U.S. has reached a milestone for COVID-19 vaccine doses administered, surpassing the 100 million dose mark on Friday afternoon. Biden campaigned on 100 million doses in his first 100 days.
Germany expects steady rise in vaccine supply through July
FILE - In this Monday, Jan. 4, 2021 file photo, frozen vials of the Pfizer/BioNTech COVID-19 vaccine are taken out to thaw, at the MontLegia CHC hospital in Liege, Belgium. The European Commission has secured an agreement with Pfizer-BioNTech for an extra 4 million doses of COVID-19 vaccines to tackle a surge of coronavirus clusters that have prompted border restrictions. (AP Photo/Francisco Seco, File)BERLIN – The German government said Wednesday it expects the supply of coronavirus vaccines to rise steadily in the coming months, hitting a peak of almost 10 million doses a week in July. Germany's vaccine campaign has lagged behind far behind countries such as Britain and the United States. Since the outbreak began, Germany has recorded more than 2.5 million confirmed cases and 72,489 COVID-related deaths.
EU gets extra vaccine doses to tackle virus border clusters
FILE - In this Monday, Jan. 4, 2021 file photo, frozen vials of the Pfizer/BioNTech COVID-19 vaccine are taken out to thaw, at the MontLegia CHC hospital in Liege, Belgium. The European Commission has secured an agreement with Pfizer-BioNTech for an extra 4 million doses of COVID-19 vaccines to tackle a surge of coronavirus clusters that have prompted border restrictions. The European Commission said Wednesday that the deal will help “tackle coronavirus hot spots” and facilitate free border movement. The European Commission said the new Pfizer-BioNTech doses will be made available for purchase to all member states on a pro-rata basis. Overall, the EU has signed six contracts for more than 2 billion vaccine doses, with Pfizer-BioNTech, Moderna, AstraZeneca, Sanofi-GSK, Johnson & Johnson and CureVac.
A shot in the arm: EU vaccine program struggles to speed up
EU leaders on Thursday, Feb. 25, 2021, during an EU summit video conference, will look at ways to improve the vaccine rollout, as they press pharmaceutical companies to respect the terms of their contracts with the 27-nation bloc. (AP Photo/Francisco Seco, File)BRUSSELS – Two months after its first vaccine shots, the European Union is still struggling to get its COVID-19 inoculation drive up to speed. EU leaders are meeting Thursday to jump-start the process, fearing that new virus variants might spread faster than Europe’s response. The EU leaders' debate will focus as much on speeding up authorizations as boosting vaccine production rates through new facilities and cutting delivery bottlenecks. AdStill, European travel restrictions don't look like they will be easing anytime soon.
EU seeks to boost credibility despite slow vaccine rollout
(AP Photo/Bernat Armangue)BRUSSELS – The European Union on Monday defended its flagging coronavirus vaccine program, which has come under criticism from the World Health Organization, EU states and recently departed member Britain. Britain’s media had a feast, depicting the EU as untrustworthy, though the U.K. government kept a low profile on the issue. Ad“These are things which happen when you are working at full speed to deal with a developing situation,” European Commission spokesman Eric Mamer said. Gallina said the bloc expects to have received 400 million doses by the end of June. Still, critics have said that the European Commission should have started clinching contracts much earlier.
EU demands that vaccine makers honor their commitments
“Europe invested billions to help develop the world's first COVID-19 vaccines," EU Commission President Ursula von der Leyen told the World Economic Forum's virtual event in Switzerland. The EU has committed to buying 300 million AstraZeneca doses with option on 100 million extra shots. The slow rollout, however, is hardly only the result of vaccine production issues. That’s why there is such big disappointment.”The European Medicines Agency is scheduled to review the Oxford-AstraZeneca coronavirus vaccine Friday and its approval is hotly anticipated. The AstraZeneca vaccine is already being used in Britain and has been approved for emergency use by half a dozen countries, including India, Pakistan, Argentina and Mexico.
The Latest: Hawaii says scarcity hinders vaccination efforts
(AP Photo/Bernat Armangue)HONOLULU — Hawaii’s leaders say limited supply is the main thing constraining distribution of the coronavirus vaccine in the state. He said the sites have set the vaccine doses aside and will receive replacement doses on Tuesday and Wednesday. ___TORONTO — Canadian officials say the country won’t be getting any Pfizer-BioNTech COVID-19 vaccine next week and 50% less than expected over the next month. U.S. pharmaceutical company Pfizer confirmed last week it would temporarily reduce deliveries to Europe and Canada of its COVID-19 vaccine while it upgrades production capacity. ___JERUSALEM — Israel’s Cabinet on Tuesday extended an existing nationwide lockdown through the end of January as the country contends with a runaway surge in coronavirus cases.
The Latest: Fla. lawyer in tobacco cases dies from COVID-19
Brad Little says people 65 and over will be able to get the coronavirus vaccine starting Feb. 1. Overall, Illinois has reported more than 1 million cases and 17,743 deaths. Ontario reported 2,903 new coronavirus cases on Tuesday, including eight new cases of a variant from the United Kingdom. ___MADRID — Spain is reporting 25,438 coronavirus cases and more than 400 deaths for the second day in a row. Italy added 14,242 coronavirus infections on Tuesday, increasing the tally to 2.3 million cases.
UK ramps up vaccine rollout, targets every adult by autumn
FILE - In this Tuesday, Dec. 8, 2020 file photo, British Prime Minister Boris Johnson watches as nurse Rebecca Cathersides administers the Pfizer-BioNTech COVID-19 vaccine to Lyn Wheeler at Guy's Hospital in London. (AP Photo/Frank Augstein, Pool, File)LONDON – Britain's health secretary said Sunday that every adult in the country will be offered a COVID-19 vaccine by the autumn as the U.K. ramps up its mass vaccination program amid a huge surge of infections and hospital admissions. More than 600,000 people age 80 and over will begin receiving invitations this week to get the coronavirus shot at new large-scale vaccine centers around England. On Friday, Britain authorized the vaccine made by Moderna, making it the third to be licensed for use in the country. The U.K. has so far inoculated about 1.5 million people with the Pfizer-BioNTech and Oxford-AstraZeneca vaccines.
With virus surging, Biden to speed release of COVID vaccines
Instead, it would accelerate shipment of first doses and use the levers of government power to provide required second doses in a timely manner. It's seen as a prudent approach, since both the Pfizer-BioNTech and Moderna vaccines require a second shot after the first vaccination. Of 21.4 million doses distributed, about 5.9 million have been administered, or just under 28%, according to the Centers for Disease Control and Prevention. Biden announced his plan after eight Democratic governors wrote the Trump administration on Friday urging it to do as much. ___This story has been corrected to show that 21.4 million doses of vaccine have been distributed, not 29.4 million.
EU regulators OK increasing doses from virus vaccine vials
The news came shortly after the EU’s executive arm said it had secured 300 million extra doses of the Pfizer-BioNTech vaccine. The EU commission later detailed in a statement that it offered to member states to purchase an additional 200 million doses of the vaccine, with the option to acquire another 100 million doses. “This would enable the EU to purchase up to 600 million doses of this vaccine, which is already being used across the EU. Von der Leyen said 75 million of the extra doses would be available during the second quarter, with the rest being delivered throughout 2021. The EU has sealed six vaccine contracts for up to 2 billion doses, with Moderna, AstraZeneca-Oxford, Sanofi-GSK, Janssen Pharmaceutica NV, Pfizer-BioNTech and CureVac.
The Latest: 2 Chinese cities urge people to stay at home
Laura Kelly said Thursday that inmates will be vaccinated after health care workers and residents of long-term care facilities. The governor warned Friday that initially, the supply of vaccines available to people other than health care workers and nursing home patients will be very limited. The announcement came as many local officials argued it was time to distribute the vaccine beyond health care workers. The governor’s plan came as the state’s new COVID-19 cases continue to rise and ICU beds are nearly full. Shots also are still being given to health care workers, first responders and staff and residents at nursing homes and other long-term care facilities.
Study suggests Pfizer vaccine works against virus variant
Syringes containing the Pfizer-BioNTech COVID-19 vaccine sit in a tray in a vaccination room at St. Joseph Hospital in Orange, Calif., Thursday, Jan. 7, 2021. (AP Photo/Jae C. Hong)New research suggests Pfizer’s COVID-19 vaccine can protect against a mutation found in the two more-contagious variants of the coronavirus that have erupted in Britain and South Africa. Bushman, who wasn't involved with the Pfizer study, cautioned that it tested just one vaccine against one worrisome mutation. Pfizer and researchers from the University of Texas Medical Branch in Galveston conducted laboratory tests to see if that mutation could thwart the vaccine. The Pfizer study found that the vaccine appeared to work against 15 additional possible mutations, but E484K wasn’t among those tested.
EU commission greenlights Moderna's COVID-19 vaccine
With the Moderna vaccine, the second one now authorized in the EU, we will have a further 160 million doses. The EU has ordered 80 million doses of the Moderna vaccine with an option for a further 80 million. The EU agency gave the green light to use the Moderna vaccine on people age 18 year and above. The Dutch were only beginning to give out vaccine shots Wednesday, the last EU nation to start doing so. Austrian Chancellor Sebastian Kurz tweeted that approval of the Moderna vaccine “is another important step in the fight against the pandemic.
EU rejects criticism for slow vaccine rollout across bloc
A nurse prepares a vaccine prior to the vaccination of elderly people at a nursing house in Athens, Monday, Jan. 4, 2021. (Louisa Gouliamaki/Pool via AP)BRUSSELS – The European Commission defended its coronavirus vaccination strategy Monday amid growing criticism in member states about the slow rollout of COVID-19 shots across the region of 450 million inhabitants. As part of its strategy, the EU has sealed six vaccines contracts, with Moderna, AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, Pfizer-BioNTech and CureVac. But only the Pfizer-BioNTech vaccine has been approved for use so far in the 27-nation bloc. With the Pfizer-BioNTech vaccine, the commission has an option for an extra 100 million doses that will bring the total to 300 million shots.
UK is first to authorize easy-to-handle AstraZeneca vaccine
FILE - This undated file photo issued by the University of Oxford on Monday, Nov. 23, 2020, shows of vial of coronavirus vaccine developed by AstraZeneca and Oxford University, in Oxford, England. The Medicines and Healthcare Products Regulatory Agency, which recommended the AstraZeneca vaccine for emergency use, did not endorse one vaccine over the other. Britain’s action likely means the World Health Organization could soon clear the AstraZeneca vaccine for use in a global effort to help poor countries, called COVAX. The European Medicines Agency said it is still assessing the AstraZeneca vaccine and has asked the company for more information on its quality, safety and effectiveness. In addition to the Serum Institute, AstraZeneca has deals with vaccine makers in Brazil, South Africa and China.
US clears Moderna vaccine for COVID-19, 2nd shot in arsenal
The U.S. is poised to give the green light as early as Friday, Dec. 18, to a second COVID-19 vaccine, a critical new weapon against the surging coronavirus. Britain, Canada and a few other countries already have cleared the Pfizer-BioNTech shot, with a European Union decision due Monday. The FDA’s main messages:--Both the new Moderna vaccine and the Pfizer-BioNTech shot require two doses several weeks apart. --In a study of 30,000 volunteers, the Moderna vaccine was more than 94% effective at preventing symptomatic COVID-19 in people 18 and older. Like with the Pfizer-BioNTech shot, expect sore arms, fever, fatigue and muscle aches, which are signs the immune system is revving up.
US clears Moderna vaccine for COVID-19, 2nd shot in arsenal
The U.S. is poised to give the green light as early as Friday, Dec. 18, to a second COVID-19 vaccine, a critical new weapon against the surging coronavirus. FDA’s decision could help pave the way for other countries that are considering the Moderna vaccine, the first-ever regulatory clearance for the small Cambridge, Massachusetts, company. The FDA’s main messages:--Both the new Moderna vaccine and the Pfizer-BioNTech shot require two doses several weeks apart. --In a study of 30,000 volunteers, the Moderna vaccine was more than 94% effective at preventing symptomatic COVID-19 in people 18 and older. But there was a hint that Moderna’s shot might provide some protection against asymptomatic infection.
WHO: Vaccine program gets access to nearly 2 billion doses
FILE - In this June 11, 2009, file photo, the logo of the World Health Organization is seen at the WHO headquarters in Geneva, Switzerland. The head of the World Health Organization says on Friday, Dec, 18, 2020 the U.N. health agencys program to help get COVID-19 vaccines to all countries in need, has gained access to nearly 2 billion doses of several promising vaccine candidates. (AP Photo/Anja Niedringhaus, File)GENEVA – The World Health Organization program to help get COVID-19 vaccines to all countries in need has access to nearly 2 billion doses of “promising” vaccine candidates, officials said Friday. Of the approximately 12 billion doses of COVID-19 vaccines the pharmaceutical industry is expected to produce next year, about 9 billion shots have already been reserved by rich countries. The U.N.-backed COVAX program needs $6.8 billion more to secure vaccine contracts and ensure delivery of allocated doses.
Dr. Frank McGeorge reveals what it’s like to get the COVID-19 vaccine
One of the health care workers eligible to get vaccinated was Local 4′s own Dr. Frank McGeorge. Dr. McGeorge received an email from Henry Ford Hospital, where he’s an emergency room physician, informing him that it was his turn to receive the vaccine. Dr. McGeorge said in the hours after receiving the shot, he didn’t notice anything different. READ: New tool will help Centers for Disease Control monitor COVID-19 vaccine recipients for any reactionsMcGeorge plans to download the V-Safe app from the U.S. Centers for Disease Control and Prevention (CDC). Ask Dr. McGeorge
FDA plans to OK 2nd COVID-19 vaccine after panel endorsement
Moderna’s shot showed similarly strong effectiveness, providing 94% protection against COVID-19 in the company’s ongoing study of 30,000 people. Moderna’s vaccine uses the same groundbreaking technology as Pfizer-BioNTech’s shot. At that one timepoint, swabs from 14 vaccine recipients and 38 placebo recipients showed evidence of asymptomatic infection, said Moderna’s Dr. Jacqueline Miller. After the FDA acts, U.S. officials plan to move out an initial shipment of nearly 6 million Moderna doses. The government’s Operation Warp Speed program has orders for 200 million doses of Moderna’s vaccine.
The Latest: Kansas mayor resigns over mask mandate threats
(AP Photo/Rich Pedroncelli, Pool, File)KANSAS — A western Kansas mayor announced Tuesday that she is resigning, effective immediately, because of threats she has received after she publicly supported a mask mandate. Brian Kemp and Public Health Commissioner Kathleen Toomey visited Savannah as the first four shots were administered to local health care workers. ___TALLAHASSEE, Fla. -- Florida’s largest hospital system said it was on track to immunize nearly 20,000 health care workers against COVID-19 as Gov. He traveled to Walter Reed National Military Medical Center in Bethesda, Md., on Monday and was given the first dose of Pfizer-BioNTech’s coronavirus vaccine. Several health care workers at Sentara Norfolk General Hospital in the eastern part of the state also received injections.
Portage proud: Eyes of the nation on small Michigan city home to Pfizer plant ahead of COVID-19 vaccine rollout
PORTAGE, Mich. – The Pfizer plant in Portage is one of two plants ready to rollout the COVID-19 vaccine. READ: A look at the small town in Michigan working on Pfizer’s COVID-19 vaccineWatch the video above for the full report. Portage, Michigan ‘proud’ to help roll out Pfizer COVID vaccineThere’s a small town in Michigan working day and night to make a vaccine for coronavirus (COVID-19). In Europe, trucks were rolling out of a Pfizer plant in Belgium headed to the U.K. where the first doses of the vaccine were given. There’s a Pfizer plant similar to that one in the town of Portage, Michigan.