Tag: Pfizer

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FDA: Pfizer Vaccine May Be Stored In Conventional Freezers

Vials of COVID-19 vaccine

Vials of COVID-19 vaccine The FDA has announced the Pfizer coronavirus vaccine may be safely stored in conventional freezers which could help with the distribution and handling of the vaccine.

Today, the U.S. Food and Drug Administration announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks.

This reflects an alternative to the preferred storage of the undiluted vials in an ultra-low temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF). The change is being reflected in updates to the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers).

“Pfizer submitted data to the FDA to support this alternative temperature for transportation and storage. This alternative temperature for transportation and storage of the undiluted vials is significant and allows the vials to be transported and stored under more flexible conditions. The alternative temperature for transportation and storage will help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccine to more sites,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

In related news, a new study from the UK indicates a single dose of Pfizer’s vaccine cuts the number of asymptomatic infections and could significantly reduce the risk of transmission of the virus.

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Coronavirus Vaccinations Begin Across U.S.

(photo: Daniel Schludi/Unsplash)
The Washington Post reports vaccinations for the coronavirus have begun today as nearly 3 million doses of the Pfizer/BioNTech vaccine are being delivered to 636 locations across the U.S. More pandemic news from the Post: • After having passed on the opportunity to secure an additional 100 million doses of the vaccine from Pfizer, the U.S.  is in talks with the pharma company for acquiring more in the second quarter of 2021, but no deal has been confirmed. • Donald Trump reversed course on a plan to have some White House staff members be among the first Americans vaccinated. The plan had been criticized in light of the Trump White House’s downplaying of the severity of the pandemic. • There’s also a late-to-the-dance public service campaign being launched to encourage people to take the vaccine Trump says he pushed so hard for. While more than eight in 10 Americans currently say they would take the vaccine, many are divided on the question of how soon.

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Trump Administration Passed On Purchasing Additional Pfizer Vaccine

From the New York Times:

Trump administration officials passed when Pfizer offered in late summer to sell the U.S. government additional doses of its Covid-19 vaccine, according to people familiar with the matter.

Now Pfizer may not be able to provide more of its vaccine to the United States until next June because of its commitments to other countries, they said.

As the administration scrambles to try to purchase more doses of the vaccine, President Trump plans on Tuesday to sign an executive order “to ensure that United States government prioritizes getting the vaccine to American citizens before sending it to other nations,” according to a draft statement and a White House official, though it was not immediately clear what force the president’s executive order would carry.

As I understand it, Pfizer has a contract with the U.S. to deliver 100 million doses. Any more would be a new order. And, as Pfizer wasn’t part of Operation Warp Speed and received no federal funds for research and development, the company isn’t beholden to the U.S. In related news, the CEOs of vaccine makers Pfizer and Moderna have declined an invitation to attend a “vaccine summit” (read that as “photo opp – victory lap”) at the White House tomorrow.

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News Round-Up: November 17, 2020

Joe Blizzard (image via Instagram)
Some news items you might have missed: • InstaHunks: Woofy Joe Blizzard (above) is getting through the rough Miami winter the best he can 🙂 • Kenneth-in-the-212: The venerable NYC-based gay blog turned 15 recently! Hit the link to check out Kenneth’s Top 10 posts over the years. Congratulations, Kenneth! • Broadway World: NBC is bringing the magic of Dr. Seuss’ world to life in a new musical production airing next month. Matthew Morrison (GLEE, Hairspray) will star as the title role in Dr. Seuss’ The Grinch Musical! set to air Dec. 9 at 8 p.m. ET/PT from the Troubadour Theatre in London.

• STAT News: Pfizer may be within days of filing for an emergency use authorization for its Covid-19 vaccine, having collected the safety data necessary to submit an application to the Food and Drug Administration, CEO Albert Bourla said Tuesday. • Eonline: 13 years after Isaiah Washington was fired for calling his Grey’s Anatomy co-star T.R. Knight a ‘faggot’ on set, he reignited his feud with former co-star Katherine Heigl, who stood up for Knight at the time of Washington’s hate speech. There was no apparent reason cited for Washington reinvigorating the incident. Oh, and he’s a big Trump supporter, so… • Instinct Magazine: The European Union has announced a new strategy to fight anti-LGBTQ laws and sentiments across its borders. The union specifically made this announcement as a response to discrimination skyrocketing in Poland and Hungary.  

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Pfizer’s COVID-19 Vaccine Shows Promise In First Phase Testing

(image via JumpStory)
  The results of the phase one testing of Pfizer and BioNTech’s COVID-19 vaccine are in and the results are promising. According to StatNews, 45 patients were divided into four groups: 12 were given a 10-microgram dose, another 12 were given a 30-microgram dose, another 12 received a 100-microgram dose, and the remaining 9 were given a placebo. The third group (100-microgram) triggered fevers in half of the patients in that group, and they did not receive follow-up doses. The first two groups (10-microgram and 30-microgram) were given a second injection three weeks after the initial dose. Fevers appeared in 8.3% of those in the 10-microgram group while 75% of those in the 30-microgram group developed fevers. None of the fevers were considered serious nor did they result in hospitalization. The vaccine was found to have generated antibodies against SARS-CoV-2 (the virus that causes COVID-19). Some of those antibodies appear to be ‘neutralizing,’ meaning they seem to prevent the virus from functioning. The levels of neutralizing antibodies were 1.8 to 2.8 times the level of those found in patients who have recovered from COVID-19. But the results weren’t conclusive in proving if the higher levels of antibodies would lead to immunity from the virus. A trial phase involving a larger group of patients will be necessary to prove that people who have received the vaccine are at least 50% less likely to become infected. That next phase of testing is expected to take place this summer. While the results of this first phase have been made public, the data has not yet been peer-reviewed or published by a medical journal. StatNews reports there are 14 different coronavirus vaccines in various phases of testing at this time. FDA Commissioner Stephen Hahn told ABC’s Good Morning America four vaccines have been given authorization to proceed with clinical trials.