UK izes Pfizer coronavirus vaccine for emergency... | tjhjmcaz.com
Facebook Twitter RSS
clearn.png
Thursday December 3rd, 2020 12:56AM

UK izes Pfizer coronavirus vaccine for emergency use

By The Associated Press
Related Articles
  Contact Editor

LONDON (AP) — Britain ized a COVID-19 vaccine for use Wednesday, greenlighting the first shot backed up by rigorous scientific review. The first vaccinations are expected within days — a major step toward eventually ending the pandemic.

The go-ahead for the vaccine from American drugmaker Pfizer and Germany’s BioNTech comes as the virus surges again in the United States and Europe, putting pressure on hospitals and forcing new rounds of restrictions that have devastated the global economy. Officials cautioned that several tough months still lie ahead, even in Britain, given the scale of the operation needed to vaccinate large swaths of the population.

The Medicines and Healthcare Products Regulatory Agency, which licenses drugs in the U.K., recommended the vaccine for emergency use after it reviewed a raft of data, including the results of clinical trials that showed it was 95% effective and offered significant protection for older people, among those most at risk of dying from the disease. But the vaccine remains experimental while final testing is done.

“This is, without any shadow of a doubt, an historic day,” said David Harper, senior consulting fellow in global health at the Chatham House think tank. “This is an unprecedented piece of science,” given that the vaccine was ized less than a year after COVID-19 was discovered.

Other countries aren’t far behind: Regulators in the United States, the European Union and Canada also are vetting the Pfizer vaccine along with a similar shot made by competitor Moderna Inc. British and Canadian regulators also are considering another shot made by AstraZeneca and Oxford University.

British Health Secretary Matt Hancock said the U.K. will begin receiving the first shipment of 800,000 doses of the Pfizer-BioNTech vaccine “within days," and people will start getting the shots as soon as it arrives. Two doses three weeks apart are required for protection.

The U.K. expects to receive “millions of doses” by the end of this year, Hancock said, adding that the exact number will depend on how fast it can be manufactured and checked for quality.

“The doses that we have for the U.K. are currently being packed (by) our colleagues at Pfizer’s facility in Belgium, ready for shipping very, very quickly,” BioNTech's chief commercial officer, Sean Marett, told reporters Wednesday.

But doses are scarce as production ramps up. BioNTech, which owns the vaccine, has so far signed deals to supply 570 million doses worldwide in 2021, with options to deliver 600 million more, Marett said. It hopes to supply at least 1.3 billion in 2021.

The German company has partnered with Pfizer to deliver the vaccine worldwide, except in China where local company Fosun Pharma will handle distribution.

The BioNTech figures still only represent a fraction of what will be needed as public health officials try to vaccinate much of the world’s population. Experts have said that several vaccines will be needed in order to quickly end the pandemic, which has killed more than 1.4 million people worldwide.

In Britain, public health officials plan to offer the vaccine first to those who are most at risk of dying from the disease and those whose jobs put them at risk of contracting the virus and spreading it to others. The vaccination program will be expanded to others as supplies become available.

The first vaccines will go to nursing 凯发k8地址home residents and those who care for them, followed by everyone over 80, and healthcare workers. From there, government plans call for vaccines to be offered roughly on the basis of age groups, starting with the oldest people first.

The drugmakers said they would immediately begin shipping limited supplies to the U.K. — and have been gearing up for wider distribution if the shot receives approval from the U.S. Food and Drug Administration, a decision expected as early as next week.

Despite the speed with which they approved the vaccine, British regulators insisted “no corners have been cut” during the review process.

The MHRA made its recommendation following a rolling review of that allowed it to assess information about the vaccine as soon as it became available. The agency began analysis of preclinical data in October, followed by information on manufacturing and quality assurance and finally the results of the clinical trials.

“The safety of the public will always come first,” Dr. June Raine, chief executive of the agency, said during a news conference. “And I emphasize again that this recommendation has only been given by the MHRA following the most rigorous scientific assessment of every piece of data.”

Getting that message to the public will be critical if any vaccination program is to be successful. Some people are worried about getting any vaccine, never mind a new one.

Jacqueline Roubians, a retired nurse, hopes most people will get the shot.

“A lot of people are skeptical but I think once they understand and see everyone else having it without hesitation, I think you’ll find that people will go and have it,” Roubians, 76, said at Brixton Market in London. “People are dying of COVID, so you make that decision: do you want to die or do you want the vaccine?”

In addition to massive logistical challenge of distributing billons of vaccines, the Pfizer-BioNTech one must be stored and shipped at ultra-cold temperatures of around minus 70 degrees Celsius (minus 94 degrees Fahrenheit).

Pfizer says it has developed shipping containers that use dry ice to keep the vaccine cool. GPS-enabled sensors will allow the company to track each shipment and ensure they stay cold.

The company also says it has agreed to work with other vaccine makers to ensure there is sufficient supply and a range of vaccines, “including those suitable for global access.”

Every country has different rules for determining when an experimental vaccine is safe and effective enough to use. Intense political pressure to be the first to roll out a rigorously scientifically tested shot colored the race in the U.S. and Britain, even as researchers pledged to cut no corners.

In contrast, China and Russia have offered different vaccinations to their citizens ahead of late-stage testing.

The vaccine made by Pfizer and BioNTech was tested in tens of thousands of people. And while the study isn’t complete, early results suggest the vaccine is 95% effective at preventing mild to severe COVID-19 disease. The companies told regulators that of the first 170 infections detected in study volunteers, only eight were among people who’d received the actual vaccine and the rest had gotten a dummy shot.

The companies also reported no serious side effects, although vaccine recipients may experience temporary pain and flu-like reactions immediately after injections.

Still to be determined is whether the shots protect against people spreading the coronavirus without showing symptoms. Another question is how long protection lasts.

The vaccine also has been tested in only a small number of children, none younger than 12, and there’s no information on its effects in pregnant women.

___

Neergaard reported from Alexandria, Virginia. Associated press writers Frank Jordans in Berlin and Jill Lawless, Pan Pylas and Jo Kearney in London contributed

__

Follow AP’s coverage at https://apnews.com/hub/coronavirus-pandemic and https://apnews.com/UnderstandingtheOutbreak.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

  • Associated Categories: U.S. News, Local/State News, Associated Press (AP), AP National News, AP Online National News, Top U.S. News short headlines, Top General short headlines, AP Health, AP World News, AP Business, AP Business - Corporate News, AP Business - Industries, AP Business - Health Care
© Copyright 2020 tjhjmcaz.com
All rights reserved. This material may not be published, broadcast, rewritten, or redistributed without permission.
UK izes Pfizer coronavirus vaccine for emergency use
Pfizer and BioNTech say they've won permission for emergency use of their COVID-19 vaccine in Britain
2:33AM ( 5 minutes ago )
Popovich knows filling US Olympic roster may be a challenge
San Antonio coach Gregg Popovich knows that the NBA schedule and how it comes very close to the start of the rescheduled Tokyo Games will be a challenge for USA Basketball to navigate next year when choosing the 12 players who will try to win a fourth consecutive men’s Olympic gold medal
2:17AM ( 20 minutes ago )
Asian shares mixed on growing hopes for stimulus, vaccines
Shares are mixed in Asia after the S&P 500 and Nasdaq composite index both set fresh record highs
1:57AM ( 41 minutes ago )
Associated Press (AP)
Disputing Trump, Barr says no widespread election fraud
Attorney General William Barr says the Justice Department has not uncovered evidence of widespread voter fraud and has seen nothing that would change the outcome of the 2020 presidential election
12:15AM ( 2 hours ago )
Thai leader faces court ruling that could cost him his job
Thailand’s highest court is set to rule on whether Prime Minister Prayuth Chan-ocha has breached ethics clauses in the country’s constitution and should be ousted from his position
12:13AM ( 2 hours ago )
Pasadena bucks LA County order, keeps outdoor dining going
The city of Pasadena has kept outdoor dining open despite Los Angeles County restricting restaurants to takeout to reduce the spread of the coronavirus
12:13AM ( 2 hours ago )
AP National News
China spacecraft lands on moon to bring rocks back to Earth
China says its spacecraft sent to return lunar rocks to Earth has collected its first samples, adding to a string of successes for Beijing’s increasingly ambitious space program
11:20PM ( 3 hours ago )
'Very dark couple of weeks': Morgues and hospitals overflow
Nearly 37,000 people died of COVID-19 in the U.S. in November, the most since the dark early days of the pandemic
11:10PM ( 3 hours ago )
US probing potential bribery, lobbying scheme for pardon
The Justice Department is investigating a secret scheme to lobby White House officials for a pardon as well as a related plot to offer a hefty political contribution in exchange for clemency
10:51PM ( 3 hours ago )
AP Online National News
The Latest: Tucson votes in mandatory nightly curfew
At the urging of Mayor Regina Romero, the Tucson City Council voted to establish a mandatory nightly curfew for three weeks in an attempt to slow the spread of COVID-19
12:16AM ( 2 hours ago )
The Latest: Hong Kong limits most gatherings to 2 people
Hong Kong is limiting most gatherings to just two people and ordering compulsory testing of workers at retirement 凯发k8地址homes and facilities for people with disabilities, among tightening measures to contain a new wave of coronavirus cases
10:56PM ( 3 hours ago )
Judge throws out Trump rules limiting skilled-worker visas
A U.S. judge in California has struck down two Trump administration rules designed to drastically curtail the number of visas issued each year to skilled foreign workers
9:02PM ( 5 hours ago )
AP Business
The Latest: Drug maker begins applying for vaccine approval
 Johnson & Johnson, one of the largest drugmakers developing a vaccine against COVID-19, has begun the process of applying for emergency approval of its vaccine from the European Medicines Agency and Health Canada
5:54PM ( 8 hours ago )
Strong start to December as S&P 500 index sets another high
Stocks scored more record highs on Wall Street Tuesday, a day after the S&P 500 closed out November with its biggest monthly gain since April
5:30PM ( 9 hours ago )
The Latest: Florida tops 1 million confirmed COVID-19 cases
Florida has joined Texas and California in surpassing 1 million confirmed COVID-19 cases as the governor has vowed not to adopt any further restrictions or impose closures like those enacted in the spring and summer
5:27PM ( 9 hours ago )
AP Business - Industries
EU eyes Dec 29 approval for 1st virus vaccine, later than US
The EU drug agency says it may need another four weeks to decide whether to grant its first approval for a coronavirus vaccine, even as ities in the United States and Britain continued to aim for a green light before Christmas
12:36PM ( 14 hours ago )
The Latest: Germany’s health minister tours vaccine center
Germany’s health minister toured a new vaccination center in Duesseldorf, preparing for possible upcoming vaccinations against the coronavirus
11:59AM ( 14 hours ago )
European regulator could OK 1st COVID-19 vaccine on Dec. 29
European regulators say they may approve a coronavirus vaccine developed by drugmakers Pfizer and BioNTech within four weeks
11:15AM ( 15 hours ago )
AP Business - Health Care
Popovich knows filling US Olympic roster may be a challenge
San Antonio coach Gregg Popovich knows that the NBA schedule and how it comes very close to the start of the rescheduled Tokyo Games will be a challenge for USA Basketball to navigate next year when choosing the 12 players who will try to win a fourth consecutive men’s Olympic gold medal
2:17AM ( 21 minutes ago )
Asian shares mixed on growing hopes for stimulus, vaccines
Shares are mixed in Asia after the S&P 500 and Nasdaq composite index both set fresh record highs
1:57AM ( 41 minutes ago )
Australia bounces out of recession as economy grows 3.3%
Australia has reported its economy grew by 3.3% in the third quarter as it rebounded from its first recession in nearly 30 years, according to new figures
1:42AM ( 56 minutes ago )
Broncos activate 3 QBs following COVID-19 rules violations
The Denver Broncos are getting their QBs back on Wednesday
1:26AM ( 1 hour ago )
Sounders back in West final after 1-0 win over FC Dallas
Defender Shane O’Neill scored on an open header early in the second half, and the Seattle Sounders beat FC Dallas 1-0 in the semifinals of the MLS Western Conference playoffs
1:06AM ( 1 hour ago )