Wednesday, 02 December, 2020


Pfizer to apply for vaccine approval on Friday

Pfizer and BioNTech to submit request for emergency use approval of their COVID-19 vaccine today		
		
	Darrell Etherington

			@etherington	 
		9 hours Pfizer and BioNTech to submit request for emergency use approval of their COVID-19 vaccine today Darrell Etherington @etherington 9 hours
Melba Vasquez | 21 November, 2020, 14:25

Within a span of just one week, the fate of the coronavirus pandemic is suddenly transforming to tentative hopefulness of better days ahead.

Echoing the positive message, EU Commission chief Ursula von der Leyen said the bloc could approve both vaccines "as early as the second half of December".

Last week Pfizer and BioNTech said preliminary results show its COVID-19 vaccine is 95% effective.

Before any vaccine is permitted in the US, it must be reviewed by the Food and Drug Administration, which requires study in thousands of people.

Data on a vaccine made by U.S. company Moderna also suggests almost 95% protection.

There is no internationally-approved vaccine to prevent the disease. The company said 45% of USA trial participants are 56-85 years old. Its early data suggests the shots are as strong as Pfizer's, and that company expects to also seek emergency authorization within weeks.

As of November 13, 41,135 participants have received a second dose of the vaccine.

"Similarly, we will do the same with respect to the COVID-19 vaccine when it becomes available". But 162 of those were folks who had received the placebo, meaning only eight subjects who had received the actual vaccine contracted the virus. It took 15 years to develop a vaccine for human papilloma virus, which can cause six kinds of cancer. Manufacturing an mRNA vaccine rather than a protein vaccine can save months, if not years. When the mRNA enters our cells, it begins to spew copies of the coronavirus' spike protein.

There are important differences between the two vaccines.

The vaccine must be stored at -70 degrees Celsius (-94 degrees Fahrenheit), temperatures much colder than those of a standard freezer. However, Moderna's vaccine can also be kept refrigerated up to 30 days and at room temperature for up to 12 hours making ease of storage and use for doctor's offices, clinics and pharmacies, more attractive. So far, the side effects are reportedly only mild to moderate, with pain mostly around the injection site, as well as the presence of fatigue and aching muscles for about a day or two.

When will it be available?

An emergency authorization expedites the usual approval process through the FDA. If the EUA approval is granted swiftly, the Pfizer vaccine rollout may begin before the end of the year.

Front-line medical workers and elderly residents of nursing homes would probably be among the first to be inoculated.

Other vaccines are in late testing stages in China and Russian Federation.

The good news is that all past pandemics eventually came to an end. I care for patients with COVID-19 and am conducting the local site for a phase 3 clinical trial of Regeneron's antibody cocktail as a tool to prevent household transmission of COVID-19.

Cases have also been soaring over the past week, reaching record daily highs.

Pfizer is formally asking federal authorities to authorize its COVID-19 vaccine for emergency use.

And the latest wave of the pandemic is hitting many regions harder than the first that swept the globe after the virus emerged in the Chinese city of Wuhan late a year ago. Unfortunately, once again, hospitals are being overwhelmed, some cities and states are reinstating lockdowns, restricting gatherings, closing schools and even discouraging holiday celebrations. Under the regular vaccine approval process, the FDA would collect the results of a company's quality testing as well as samples that the agency could test itself to ensure they meet USA standards before doses are released to the public.

Recommended

loading...
...

Wipeout contestant dies while filming TV show Wipeout contestant dies while filming TV show Production was paused Thursday and Friday, and the show was heading into a preplanned week off for the Thanksgiving holiday. There are said to be precautions and safeguards on set including medical exams to every contestant before they compete.

Trump options narrow as MI backs Biden win Trump options narrow as MI  backs Biden win Trump net about 1,200 additional votes because of previously uncounted ballots, can not occur in the state's coming runoff elections for U.S.

Brazil beat Uruguay as Cavani sent off Brazil beat Uruguay as Cavani sent off The top four teams will qualify automatically but the fifth-placed team will enter an inter-regional play-off. However, the sensation team of the hour is Ecuador , which outclassed Colombia 6-1 (4-1) on matchday four.

In breathtaking news, Cyberpunk 2077 lets you play as Keanu Reeves In breathtaking news, Cyberpunk 2077 lets you play as Keanu Reeves On the contrary, this is the time where many improvements are being made which will then be distributed via a Day 0 patch. So he recently gave some insight into the differences between doing Cyberpunk 2077 and The Matrix on social media .

Apple Releases Revised Version of iOS 14.2 for iPhone 12 Owners Apple Releases Revised Version of iOS 14.2 for iPhone 12 Owners Apple Authorized Service Providers were notified that the iPhone-maker is looking into the problem, according to MacRumors . This guidance suggests that Apple may be confident that it can fix the issue in a future software update.

Spokesman: Trump's eldest son tests positive for coronavirus Spokesman: Trump's eldest son tests positive for coronavirus The spokesman said the younger Trump learned of his diagnosis earlier this week, but he has no symptoms and has been quarantining. The president's eldest son is also said to be following all medically recommended COVID-19 guildelines .

Multiple victims in Wisconsin mall shooting, gunman on the run Multiple victims in Wisconsin mall shooting, gunman on the run Jill Wooley was inside Macy's with her 79-year-old mother when they heard eight to 12 gunshots just outside the store entrance. The shooter was no longer at the scene when emergency personnel arrived, Weber said. "The mall is now closed".

Rockstar Teasing New Grand Theft Auto Online Content Rockstar Teasing New Grand Theft Auto Online Content News of the online expansion comes after Rockstar announced that GTAV's re-release in 2021 would be " expanded and enhanced ". The update will introduce new ways to approach Heists, playing the whole thing solo or with up to three crewmates.

Americans urged not to travel during Thanksgiving Americans urged not to travel during Thanksgiving Are hospitals in your community or the community you will be visiting overwhelmed with patients who have COVID-19? See CDC's guidance: https://t.co/zLzjYg5X6P .

Saints place Brees on injured reserve Saints place Brees on injured reserve A Pro Bowler in 2015, Winston has completed 2,559 passes for 19,812 yards and 121 touchdowns with 88 interceptions in his career. The undrafted 30-year-old did serve as a quarterback during his five-year college career at Brigham Young University, however.

Dwight Howard Secretly Marries 23-Year-Old LA Sparks Star Te'a Cooper Dwight Howard Secretly Marries 23-Year-Old LA Sparks Star Te'a Cooper Howard left the franchise on bad terms following the 2012-13 season, making it a big surprise when he returned in 2019-20. While Howard isn't signing with the Lakers yet, the team didn't get completely shut out in free agency Friday.

Australian Open organisers confronted by new challenges Australian Open organisers confronted by new challenges Horacio and I will have to quarantine there, but at least we can train during confinement", Marcel Granollers said in London . Victorian premier Daniel Andrews expects the 2021 Australian Open to be held in a "bubble" amid the coronavirus pandemic.

New York City schools to close again as city fights coronavirus New York City schools to close again as city fights coronavirus Under state rules, if New York City's seven-day state testing average exceeds 3% for more than 10 days, it would hit Gov. As the rate neared that point last week, de Blasio advised parents to prepare for a possible shutdown within days.

30K volunteers, 95 infections, 94.5% efficacy: Moderna vaccine breakthrough 30K volunteers, 95 infections, 94.5% efficacy: Moderna vaccine breakthrough The vaccine was well tolerated, with the majority of side-effects classed as mild or moderate. A review of solicited adverse events indicated that the vaccine was generally well tolerated.

Azerbaijani army enters territory ceded by Armenian forces Azerbaijani army enters territory ceded by Armenian forces David Tonoyan, who was replaced as defence minister on Friday, said in a statement that he hoped the move will help ease tensions. In a televised address, Azerbaijan President Ilham Aliyev called Armenians who destroyed property as they fled a "wild enemy".