A top official of Operation Warp Speed — the U.S. government’s massive effort to develop and distribute a coronavirus vaccine — confidently predicted Monday that everyone who wants a vaccine will be able to get one by June.

Lt. Gen. Paul Ostrowski (Ret.), the director of Operation Warp Speed’s supply, production and distribution, was asked during an interview on MSNBC about his vaccination expectations by June:

“100% of Americans that want the vaccine will have had the vaccine by that point in time that time. We’ll have over 300 million doses available to the American public well before then.”

It was unclear if he was referring to the first dose of the vaccine or both doses. The COVID-19 vaccination process will take around six weeks, with a month before two vaccinations, and then about two weeks to make sure antibodies have developed.

Essential workers and those most at risk will get the vaccine first, with mass availability for the general U.S. population not expected until the spring.

https://www.marketwatch.com/story/100-of-americans-that-want-the-vaccine-will-have-had-the-vaccine-by-june-says-operation-warp-speed-official-11606795433

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Vice President Mike Pence told governors on Monday that distribution of a coronavirus vaccine could begin by the third week of December, signaling that U.S. regulators will swiftly approve an emergency authorization for the first shots.

“We strongly believe the vaccine distribution process could begin the week of December 14,” Pence told governors, according to a summary of the call provided by the office of Washington Governor Jay Inslee. “The American people deserve to know the cavalry is on the way.”

Pence told governors they will have the final say on vaccine distribution as the “ultimate arbiters” in their states, according to the summary.

Moderna Inc. joined Pfizer Inc. on Monday in requesting the FDA issue an emergency use authorization for its shot. Both vaccines are better than 90% effective, according to preliminary results of clinical trials, though their distribution challenges include requiring two shots.

https://www.bloomberg.com/news/articles/2020-12-01/pence-says-covid-vaccine-distribution-could-begin-mid-december

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U.S. President Donald Trump said on Thursday that delivery of the coronavirus vaccine would begin next week and the week after.

Speaking to U.S. troops overseas via video link to mark the Thanksgiving holiday, Trump said the vaccine would initially be send to front-line workers, medical personnel and senior citizens.

https://www.reuters.com/article/us-health-coronavirus-trump/trump-says-coronavirus-vaccine-deliveries-to-begin-next-week-idUSKBN2862GY

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Operation Warp Speed’s Chief Science Advisor Moncef Slaoui told CNBC that Americans can expect to get back to ‘normal’ by summer 2021, as families across the United States spend Thanksgiving apart this year in order to keep their loved ones safe. 

“We hope that we would have vaccinated 70% to 80% of the U.S. population by May or June of 2021, so I would hope that by summer, we should be substantially back to normal,” Slaoui said in a Wednesday evening interview on “The News with Shepard Smith”. 

Doctors and scientists, however, are reassuring Americans that there will be a reprieve. Two weeks after Thanksgiving, the FDA will meet to discuss whether to green-light Pfizer’s vaccine. If it does, the government plans to ship out 6.4 million doses to communities around the country.

Slaoui said that inoculating all Americans will be a “challenge” but he thinks it is achievable. “People need to know that every year between 140 million to 180 million doses of flu vaccine are produced, distributed, and inoculated in the U.S. population in a period that goes between the month of August and the month of, maybe, January,” Slaoui said. “So, we may be doubling that number over the period of time, but it’s not from scratch, which was very different from the testing.”

https://www.cnbc.com/2020/11/25/we-should-be-back-to-normal-by-summer-2021-says-operation-warp-speed-advisor.html

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The White House is considering rescinding entry bans for most non-U.S. citizens who recently were in Brazil, Britain, Ireland and 26 other European countries, five U.S. and airline officials told Reuters.

The Trump administration imposed the bans in a bid to contain the novel coronavirus pandemic. It is not considering lifting separate entry bans on most non-U.S. citizens who have recently been in China or Iran, the officials said.

The plan has won the backing of White House coronavirus task-force members, public health and other federal agencies, the people briefed on the matter said, but President Donald Trump has not made a final decision and the timing remains uncertain.

The White House, Department of Homeland Security and Centers for Disease Control and Prevention (CDC) did not comment.

Many administration officials argue the restrictions no longer make sense given that most countries around the world are not subject to the entry ban. They contend lifting the restrictions would be a boost to struggling U.S. airlines, which have seen international travel fall by 70%, according to airline industry data.

https://www.reuters.com/article/BigStory12/idUSKBN2851EP

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Centers for Disease Control and Prevention (CDC) Director Robert Redfield said Tuesday that a COVID-19 vaccine would be released “by the end of the second week of December.”

During a segment on Fox News, Redfield was asked by "The Daily Briefing" host Dana Perino how government agencies would determine who received the vaccine first.

“I think it's really important. First, it's, you know, exceptional that we have these vaccines. And it's very exciting. And, again, it just reinforces why I want people to be vigilant because we're turning the corner now. You don't want to be the last group to end up getting COVID, because the vaccine is going to begin to be rolled out probably by the end of the second week of December,” Redfield said.

The CDC director said that there will be a hierarchy to who will receive the vaccine first based on risk and exposure.  

“Initially, in a hierarchical way, nursing home residents and then some combination of health care providers and individuals at high risk for a poor outcome. And those decisions are in the process of being finalized as we speak.”

https://thehill.com/homenews/news/527408-cdc-director-covid-19-vaccine-will-be-rolled-out-second-week-in-december

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As G20 leaders pledged to ensure the equitable distribution of Covid-19 vaccines, drugs and tests so that poorer countries are not left out, the US, UK and Germany each announced plans to begin vaccinations in their countries in December, while Spain said it would start administering the vaccine to its citizens in January.

Britain could give regulatory approval to Pfizer-BioNTech’s Covid-19 vaccine as early as this week, even before the US authorises it, the UK’s Telegraph newspaper reported on Sunday. Pfizer and BioNTech could secure emergency US and European authorisation for their Covid-19 vaccine next month after final trial results showed a 95% success rate and no serious side effects.

Moderna last week released preliminary data for its vaccine showing 94.5% effectiveness.

The better-than-expected results from the two vaccines, both developed with new messenger RNA (mRNA) technology, have raised hopes of an easing of a pandemic that has killed more than 1.3 million people.

In the US, the head of the US vaccine program, Moncef Slaoui, said the first Americans to receive a vaccine could get it as soon as 11 December, CNN reported on Sunday.

“Our plan is to be able to ship vaccines to the immunisation sites within 24 hours from the approval, so I expect maybe on day two after approval on the 11th or the 12th of December,” he said in an interview to CNN.

Citing government sources, the Telegraph also said the UK’s National Health Service had been told to be ready to administer it by 1 December.

Britain formally asked its medical regulator, the MHRA, last week to assess the suitability of the Pfizer-BioNTech vaccine. The UK Department of Health had no comment on Sunday on when the first vaccinations would be administered.

Britain has ordered 40m doses and expects to have 10m doses, enough to protect 5 million people, available by the end of the year if regulators approve it.

Germany could also start administering shots of Covid-19 vaccines as soon as next month, health minister Jens Spahn was quoted as saying on Sunday. He said Spain and Germany were the first European Union countries to have a complete vaccination plan in place.

“There is reason to be optimistic that there will be approval for a vaccine in Europe this year,” Spahn said in an interview with publishing group RedaktionsNetzwerk Deutschland. “And then we can start right away.”

https://www.theguardian.com/world/2020/nov/23/us-germany-and-uk-could-start-covid-vaccinations-as-early-as-december

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As the United States recorded its 12th million Covid-19 case, the Trump administration’s vaccine program adviser predicted that life in America could be back to normal around May of 2021 as immunization is set to begin.

The note of optimism came even as millions of Americans were expected to travel for the upcoming Thanksgiving holiday this week and many appeared to be ignoring warnings from health officials about furthering the spread of the infectious disease.

Moncef Slaoui, chief scientific adviser of the government’s Operation Warp Speed vaccine development and distribution program, which involves the military and the private sector as well as government health experts, said that pending regulatory approval for the first vaccine means the first Americans could be vaccinated outside of clinical trial by mid-December.

And Slaoui said that if the vaccination distribution and immunization plan goes well, enough Americans should be vaccinated by “May or something like that” of 2021 to allow life to go back to normal.

The first application to the US government for vaccine approval was made on Friday by the pharmaceutical team of Pfizer and its partner BioNTech.

The Food and Drug Administration (FDA) regulatory body is scheduled to hold a key meeting on December 10 that could award the team emergency authorization for the vaccine.

“By December 11 or 12 I’m hopeful the first people will be immunized across the US, in all states,” Slaoui told CNN’s State of the Union politics show on Sunday morning.

https://www.theguardian.com/world/2020/nov/22/us-vaccine-expert-life-could-be-back-to-normal-may

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The Pfizer-BioNTech vaccine has now proved 95% effective in preventing coronavirus and has met the safety criteria needed for emergency authorisation, the firms have said.

Pfizer and BioNTech say they plan to submit the COVID-19 vaccine to the US regulator for emergency use approval "within days" before sharing with others around the world.

The UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), is poised to fast-track authorisation of the vaccine, which could mean it is rolled out to priority groups from mid-December.

Final efficacy analysis of the jab showed 95% were protected from the virus within 28 days of the first dose - up from when results of Phase 3 trials were shared last week.

It also proved 94% effective among adults over the age of 65 - who are generally more vulnerable.

"No serious safety concerns" were reported in the analysis, with only 2% of the 43,000 involved reporting a headache and 3.7% reporting fatigue, the companies said.

https://news.sky.com/story/covid-19-pfizer-biontech-vaccine-now-95-effective-and-will-be-submitted-for-authorisation-within-days-12135473

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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.

“We are very close to submitting for an emergency use authorization,” Bourla said during the STAT Summit, which this year is a virtual event. Bourla sidestepped the question of whether Pfizer’s filing would be made this week.

“Let us not create expectations,” he said in conversation with STAT’s Matthew Herper. “We will announce it as soon as we are doing it.”

The FDA required manufacturers to follow at least half of the people who received vaccine in their Phase 3 clinical trials for two months, to ensure there is at least that amount of safety data before a vaccine is considered for use.

Pfizer, which is producing a messenger RNA, or mRNA, vaccine, was the first to announce preliminary results from its Phase 3 trial. It is expected it will be the first Covid-19 vaccine cleared for use in the United States. If all goes according to plan, vaccinations could begin sometime in December.

https://www.statnews.com/2020/11/17/pfizer-may-be-within-days-of-filing-emergency-authorization-request-for-covid-19-vaccine

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