December 8 coronavirus news

An advisory committee to the US Food and Drug Administration on Tuesday released a briefing document detailing data on Pfizer and BioNTech's Covid-19 vaccine candidate, which will be considered this week for emergency use authorization in the United States.

The document confirms that the vaccine's efficacy against Covid-19 was 95%, occurring at least seven days after the second dose – an efficacy that had been previously reported by Pfizer. The proposed dosing regimen for the vaccine is to administer two 30-microgram doses 21 days apart.

However, the document also notes that the vaccine, called BNT162b2, appears to provide "some protection" against Covid-19 following just one dose.

The document describes the efficacy of Pfizer's vaccine in the time between the first and second dose as 52.4%, but the document notes that "the efficacy observed after Dose 1 and before Dose 2, from a post-hoc analysis, cannot support a conclusion on the efficacy of a single dose of the vaccine, because the time of observation is limited by the fact that most of the participants received a second dose after three weeks."

In other words, "the trial did not have a single-dose arm to make an adequate comparison."

The document goes on to detail the safety profile of the vaccine as "favorable" and notes that the most common adverse reactions to the vaccine have been reactions at the injection site, fatigue, headache, muscle pain, chills, joint pain and fever.

Severe adverse reactions occurred in less than 4.6% of participants, were more frequent after the second dose and were generally less frequent in older adults as compared to younger participants, according to the document. The document adds that swollen lymph nodes also may be related to vaccination.

A total of six participants died during the trials, and "all deaths represent events that occur in the general population of the age groups where they occurred, at a similar rate."

The document will be discussed in a meeting on Thursday, where the FDA's Vaccine and Related Biological Products Advisory Committee will provide recommendations to the FDA on whether the vaccine is effective in preventing Covid-19 in people 16 and older and whether the potential benefits of the vaccine outweigh the risks.

"The committee will also discuss what additional studies should be conducted by the vaccine manufacturer following issuance of the EUA to gather further data on the safety and effectiveness of this vaccine," according to the document.

When asked by NBC's Savannah Guthrie if Queen Elizabeth and Prince Philip would receive a Covid-19 vaccine on camera, British Foreign Secretary Dominic Raab said that's not likely, but they will get vaccinated following the phased approach.

Due to their ages, Queen Elizabeth, 94, joins her husband Prince Phillip, 99, in being among the most vulnerable groups first in line for the Pfizer/BioNTech vaccine as it rolled out today in the UK.

Last week, CNN reported that former Presidents Barack Obama, George W. Bush and Bill Clinton are volunteering to get their Covid-19 vaccines on camera to promote public confidence in the vaccine's safety once the US Food and Drug Administration authorizes one.

“We are comfortable we will be getting vaccines to the people who need them as soon as possible,” Moncef Slaoui, chief scientific adviser of Operation Warp Speed, told ABC’s George Stephanopoulos when asked whether there is anything that the government or operation could do to help supply chain issues.

Slaoui said this was because “there are vaccine doses from Moderna, there are vaccine doses from Pfizer,” adding that they will work with Pfizer to try to increase their capacity.

Slaoui's comments come after The New York Times on Monday first reported that the Trump administration turned down an offer from Pfizer to buy more doses of its Covid-19 vaccine in the late summer.

Slaoui today said that summer was not the time to buy more vaccine doses – and that the right time to do that is when it becomes clear how well the vaccines perform.  

Slaoui said that during the summer, “If somebody came to us and said, ‘Let’s buy more of this vaccine or that vaccine,’ no one reasonably would buy more from any one of those vaccines because we didn’t know which one would work and which one may be better than the other.”

He said that – given the strategy they have taken – once the vaccine’s performance was known would be the right time to order more doses, “which we may be doing.”

“And frankly, the constructive thing to do, if one of the suppliers has challenges producing enough vaccine doses, is to roll (up) our sleeves and help ensure that capacity can be increased and have more vaccine doses,” Slaoui said.

He also said that there were two more vaccines from AstraZeneca and Johnson & Johnson completing Phase 3 trials in January, “and most likely, I hope,” be available for use in February. 

“We have tens of millions of doses of those vaccines, you know, participating, to the volume of vaccines we need to immunize the US population as we promised, all of it by the middle of the year 2021 – and that’s still on track,” Slaoui said.

The Serum Institute of India (SII) has sought emergency use approval from regulators for a domestically produced "Covishield" shot using the Covid-19 vaccine developed by AstraZeneca and Oxford University.

India's Health Ministry said on Tuesday that "some of the vaccine candidates may get licensed in the next few weeks."

"The Prime Minister has interacted with all vaccine manufacturers and scientists. There are vaccine candidates in the clinical trial stage in India,” Rajesh Bhushan, a senior health ministry official said.

The SII, based in the western city of Pune, applied for emergency authorization on Monday, and has a deal in place with AstraZeneca to produce and distribute its vaccine domestically.

“Once we get a green signal from our scientists, we'll launch a massive production of the vaccine. We've made all the preparations and drawn an outline to ramp up production of vaccine and to make it available to each and every person in shortest possible time,” Bhushan added.

On Monday, SII CEO Adar Poonawala tweeted: "As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorization for the first made-in-India vaccine, COVISHIELD. This will save countless lives."

As cases of Covid-19 continue to rise across the United States, a poll of firefighters in the Fire Department of New York City (FDNY) found that nearly 55% of respondents would not get a Covid-19 vaccine if offered by the department, their union president told CNN Monday.

Despite research that shows firefighters were 15 times more likely to be infected, a majority of those who took the poll declined the offer of a vaccine.

Over 2,000 firefighters, or about 25% of the department's approximately 8,200 members, responded to the poll, according to Uniformed Firefighters Association President Andrew Ansbro.

The poll, which closed on December 5, asked firefighters, "Will you get the COVID-19 Vaccine from Pfizer when the Department makes it available?" with "Yes" or "No" answers, according to the results provided to CNN by Ansbro.

Read more here:

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55% of FDNY firefighters wouldn't get a Covid-19 vaccine if offered by the department, poll finds

The United Kingdom has begun administering the first doses of the Pfizer/BioNTech vaccine outside clinical trials, launching a sprawling public health campaign to vaccinate tens of millions of people in just a matter of months. It marks a significant turning point in the fight against Covid-19, months into a pandemic that has left more than 1.5 million dead.

Margaret "Maggie" Keenan, who turns 91 next week, became the first person in the world to receive an authorized, fully-vetted coronavirus vaccine.

"It's the best early birthday present I could wish for," Keenan said after receiving the jab in Coventry, England, dressed in a festive "Merry Christmas" T-shirt. "It means I can finally look forward to spending time with my family and friends in the New Year after being on my own for most of the year."

The second patient to receive a shot was an 81-year-old man named William Shakespeare (yes, you read that right).

Keenan and Shakespeare were among a handful of people across Britain -- those aged over 80, nursing home staff and health care workers -- who were administered doses of the Pfizer/BioNTech vaccine on Tuesday morning, a week after the UK leapfrogged the rest of Europe and the United States to become the first Western nation to approve it.

Read the full story here.

A version of this story appeared in the December 8 edition of CNN's Coronavirus: Fact vs. Fiction newsletter. Sign up here to receive the need-to-know headlines every weekday.

CORRECTION: An earlier version of this post misspelled the name of vaccine recipient William Shakespeare. This has been corrected.

Australia will extend restrictions on overseas travel until March next year due to the Covid-19 pandemic, the country's Health Minister Greg Hunt said Tuesday.

The restrictions limit cruise vessels' movement and outbound international travel. Retail stores at international airports in Australia are also subject to restrictions in their operations.

Hunt said the government has advised extending the restrictions on overseas travel until March 17, 2021, because the pandemic has posed "an unacceptable public health risk."

Australia's Governor General David Hurley will consider the proposed extension within this week, Hunt said.

"The Australian Government is working closely with state and territory agencies and the cruise industry, to develop a framework for the staged resumption of cruise ships in a manner that is proportionate to the public health risk," he added.

Michael Fox, a pediatric doctor at an Accidents and Emergency unit in Cardiff, Wales, was one of the first people in the world to get the Pfizer/BioNTech vaccine outside of clinical trials.

The 32-year-old doctor got his vaccine at a clinic on Tuesday morning. He told CNN the injection felt just like a flu shot, nothing more than a scratch.

On his way to the vaccination center in the Welsh capital earlier this morning, Fox said he was thinking about all the researchers, scientists and volunteers who helped make this day a reality.

The Welsh government is planning to administer 6,000 doses by the end of this week. For now, immunization is available by invitation only for those aged 80 and over, for care home staff, and health and social care workers.The demand for the vaccine is huge and to avoid people simply showing up to the center, the Welsh government has asked CNN not to release its exact location.

Most of those coming to the facility this morning were nurses, doctors and others who are working on the front lines of the pandemic.

As patients across the UK become some of the first in the world to receive a coronavirus vaccine, Prime Minister Boris Johnson warned Tuesday that cases are still rising in some parts of the country, telling citizens that now is not the time to relax.

“It’s amazing to see the vaccine come out, it’s amazing to see this tremendous shot in the arm for the entire nation, but we can’t afford to relax now,” Johnson said during a visit to a newly-opened vaccination center in London. 

“It is important for people to understand that the virus is alas still rising in some parts of the country,” the Prime Minister continued, adding that the vaccine will “gradually make a huge difference” to the national infection rate. 

The UK is the first Western nation to begin vaccinating its citizens against Covid-19, less than a week after approving the Pfizer/BioNTech vaccine.

Asked whether he would be receiving the vaccine, the Prime Minister told reporters that he is “not in the priority group” outlined by the British government, but encouraged those who are eligible to take the vaccine. 

“I would just say to all those who are scared, don’t be…you see people take the vaccine this morning, in large numbers, people are going to be taking it in the next few days and and weeks and there is nothing to be nervous about,” Johnson said.