Pfizer vaccine doses can be spaced out up to 6 weeks apart, WHO advisers say
From CNN’s Naomi Thomas
A nurse administers a dose of the Pfizer-BioNTech Covid-19 vaccine to a patient in Haxby, England, on December 22. Lindsey Parnaby/AFP via Getty Images
The second dose of Pfizer and BioNTech’s coronavirus vaccine can be delayed for as long as six weeks if need be, World Health Organization advisers said Friday.
The Strategic Advisory Group of Experts on Immunization (SAGE), which advises WHO about vaccines, published interim guidance for the use of the Pfizer/BioNTech Covid vaccine under emergency use listing on Friday.
“WHO’s recommendation at present is that the interval between doses may be extended up to 42 days (6 weeks), on the basis of currently available clinical trial data,” the guidance document reads.
Pfizer’s vaccine is supposed to be given as two doses 21 days apart. On Friday, President-elect Joe Biden’s team said his administration would release all doses of coronavirus vaccines right away, instead of holding back half to ensure second doses are given on time, as the Trump administration has been doing.
If more information becomes available on longer intervals it may be revised and countries should ensure that any adjustments don’t affect the likelihood of receiving the second dose of vaccine, SAGE said.
Some countries face “exceptional circumstances of vaccine supply constraints combined with a high disease burden,” the panel said.
1:05 p.m. ET, January 8, 2021
Denmark limits travel from all countries to curb spread of Covid-19
From CNN’s Antonia Mortensen in Milan and Martin Goillandeau
Empty terminal 3 at Copenhagen Airport Kastrup is seen on March 24. Ida Guldbaek Arentsen/Ritzau Scanpix/AFP via Getty Images
Denmark will introduce entry restrictions from the rest of the world, in an effort to limit the spread of coronavirus, the country’s Minister of Foreign Affairs Jeppe Kofod said on Friday.
Danish authorities also advise against all travel abroad starting Saturday.
In addition to the recommendations to cancel all travel out of the country, the government will also tighten the restrictions on entry, making it possible only for people with a recognizable purpose and who can present a negative coronavirus test that is a maximum of 24-hours old to enter Denmark. A recognizable purpose may, for example, be having a job or family in Denmark.According to the new regulations, Danes who have been infected with coronavirus abroad will not be able to travel home by plane.
“The new restrictions run until 17 January and also mean that Danes living abroad are encouraged to stay where they are,” Kofod told reporters. “What we are doing now, we are doing so as not to stumble upon the finish line in the fight against the corona,” the minister added.
The move follows a decision this week to further tighten an already stringent economic and social lockdown.
According to the Danish government, a broad section of the population is expected to be vaccinated against Covid-19 by June. All Danes who accept the offer of the vaccine against coronavirus can be vaccinated with another vaccine no later than June 27, according to a calendar available on the Danish Health Authority's website.
The announcement comes on the day Denmark has secured 3.9 million doses of vaccine, after the European Union entered into a new agreement with Pfizer-BioNTech.
1:44 p.m. ET, January 8, 2021
Kentucky governor: Release all vaccine doses with "assurances the second dose will be there"
From CNN's Sheena Jones
Kentucky Gov. Andy Beshear agrees with the President-elect Joe Biden’s plan to release as many Covid-19 vaccine doses as possible, he told CNN on Friday.
This comes after Biden’s team said they will release as much of the vaccine as possible.
“We are ready to vaccinate a lot more people and this would help us, at the same time we have to ensure those second doses come,” Beshear said on CNN.
Ultimately Beshear wants as many Covid-19 vaccine doses released with "assurances the second dose will be there."
He added the second doses need to come within the correct timeframe so the vaccine is still 95% effect.
“We got to vaccinate as many people as possible,” Beshear said adding, “the vaccine is the only way we can help people and beat this virus,” he said.
The governor said if the state runs out of people in one group to vaccinate they will move to the next group and vaccinate as many people as possible.
The next group of people consist of people over 70, bus drivers, and other essential workers, the governor said.
Kentucky has vaccinated at least 50,000 people in the last three days, he said.
Watch:
12:57 p.m. ET, January 8, 2021
Teachers in Chicago who don't go back to school may not be paid, officials say
From CNN's Bill Kirkos and Melissa Alonso
Jonathan Daniel/Getty Images
Chicago Mayor Lori Lightfoot on Friday confirmed that Chicago Public Schools (CPS) will resume in-class instruction on Monday despite recent pushback from the Chicago Teachers Union to delay reopening.
Pre-K students and cluster program students are scheduled to return to Chicago classrooms on Jan. 11, according to the CPS reopening plan. Teachers and staff were asked to return to schools a week before to prepare for in-class instruction, but only half did so, CNN has reported.
Lightfoot said that the pandemic "has completely upended our sense of normalcy" but "CPS has worked diligently to provide the best possible remote learning experience."
Chicago Public Schools CEO Dr. Janice Jackson said the district does not need a union agreement to reopen schools and any teachers who don’t show up will be marked absent without pay.
Union leadership has been pushing to delay school reopenings and have proposed inoculating all teachers before a return to the classroom, along with other mitigation measures, CNN has reported.
Lightfoot said several "myths" were circulating, including rumors that "proper PPE won't be supplied to students and staff" and that many of the schools won't be properly ventilated.
The mayor said a recent $8.5 million investment would ensure that every school will be equipped with HEPA, or high-efficiency particulate air purifiers, which purify over 99% of viruses and bacteria.
Jackson added that the city has invested over $100 million to ensure students return to the safest environment as possible.
"The health of our students and their families...is our number one priority," said Lightfoot who stressed that she understands people's concerns about returning to classrooms. "I get that," she added.
According to Lightfoot, 77,000 parents have said they want schoolhouses to open for in-class instruction.
11:42 a.m. ET, January 8, 2021
French medical regulator approves Moderna Covid-19 vaccine for rollout
From CNN's Sandrine Amiel and Gaëlle Fournier
Joe Raedle/Getty Images
French medical regulator, the High Health Authority (HAS), has approved the rollout of Moderna’s coronavirus vaccine in the country, according to a statement released by the regulator on Friday.
The decision comes after the European Medicines Agency approved the Moderna vaccine on Wednesday.
HAS noted that Moderna was “the second vaccine available to fight Covid-19” in France after Pfizer-BioNTech’s and that “it will help amplify the vaccination campaign.”
On Thursday, Health Minister Olivier Véran said the first 50,000 doses of Moderna will be delivered on Monday, aiming to reach over 2 million by June.
“In all, we expect a little over 100,000 vaccines for the month of January for Moderna, an additional 500,000 in February, a little over a million in March and April and over 2 million in May and June,” Véran said.
France has come under scrutiny for its slow vaccination process, administering a total of 45,000 people as of Thursday, a number which has left them behind compared to European neighbors.
11:42 a.m. ET, January 8, 2021
New York City reports a more than 9% Covid-19 positivity rate
From CNN's Kristina Sgueglia
Angela Weiss/AFP/Getty Images
Covid-19 continues to surge in New York City as health officials report nearly 4,000 new confirmed and positive cases and a 9.38% positivity rate on the city's seven-day rolling average, Mayor Bill de Blasio said.
The city also reports at least 3,960 cases on a 7-day rolling average, de Blasio added.
At least 256 more people are currently in the hospital. That hospitalization rate now stands at 4.33 per 100,000 people.
On vaccines: De Blasio is pushing for the authorization to give the Covid-19 vaccine to those 75 and older, lamenting that the state hasn’t opened up to the next category.
"Our seniors, our elders, those we love, who are in danger, the single most vulnerable population right this minute in New York City and the state of New York will not allow us to vaccinate," he said.
He also said that the federal initiative to support vaccinations in nursing homes “hasn’t happened the way it needs to.”
According to the city's Department of Health, of the 100,000 people living or working in nursing homes only about 16,000 have been vaccinated. There’s an allotment of 54,000 doses through the federal program, he said.
11:36 a.m. ET, January 8, 2021
Millions of doses of the Covid-19 vaccines are rolling out. Here's why you could still get infected.
From CNN's Eric Levenson
Joe Raedle/Getty Images
On December 18, a San Diego emergency room nurse was given a shot of the Covid-19 vaccine. A week later, he tested positive for the virus, CNN affiliate KGTV reported.
Stories like this will become more common as millions of Americans are administered the Pfizer-BioNTech and Moderna vaccines over the coming months. Over time, many who are vaccinated will still get infected with the novel coronavirus.
But the vaccines have been shown to be 95% effective, so how can this happen?
Here's why:
Immunity doesn't kick in right away: It takes time for vaccines to build up immunity, and the two authorized coronavirus vaccines both require two doses, given several weeks apart, to train the body's immune system. People can be exposed to coronavirus right before being vaccinated, or right after, and there won't be time for the body to develop its defenses.
Vaccines might not provide perfect protection: No vaccine is 100% effective, and the makers of coronavirus vaccines are still evaluating whether the shots protect against all infections, or just those that cause symptoms. The CDC estimates that 40% of people who test positive don't have symptoms.
It's not because the vaccine gave you the virus: The current coronavirus vaccines cannot infect anyone with the virus. They don't contain the virus. Instead, they carry a small stretch of genetic material known as messenger RNA or mRNA that tells your body how to fight Covid-19.
Others might not be safe from you: People who are themselves immune to the virus might be exposed to it and transmit it to others. It can grow in the nose, says Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.
11:38 a.m. ET, January 8, 2021
Biden will aim to release every available Covid-19 vaccine dose when he takes office, breaking from Trump
From CNN's Sara Murray
Chip Somodevilla/Getty Images
President-elect Joe Biden will aim to release every available dose of the coronavirus vaccine when he takes office, a break with the Trump administration's strategy of holding back half of US vaccine production to ensure second doses are available.
What this means: Releasing all vaccine doses on hand could quickly ratchet up the availability of coronavirus vaccines by allowing more people access to a first dose. It could also be a risky strategy as both Pfizer/BioNTech and Moderna's vaccines require two doses, administered at specific intervals, and vaccine manufacturing has not ramped up as rapidly as many experts had hoped.
"The President-elect believes we must accelerate distribution of the vaccine while continuing to ensure the Americans who need it most get it as soon as possible. He supports releasing available doses immediately, and believes the government should stop holding back vaccine supply so we can get more shots in Americans' arms now," said TJ Ducklo, a spokesperson for Biden's transition. "He will share additional details next week on how his Administration will begin releasing available doses when he assumes office on January 20th."
The comment from Biden's transition comes after a group of governors wrote a letter to Health and Human Services Secretary Alex Azar and Operation Warp Speed Chief Operating Officer Gen. Gustave Perna pressing the federal government to distribute "reserved doses" of the Covid-19 vaccine to states that need them.
"Our states are ready to work around the clock to ramp up distribution, get more shots in arms, and save more American lives. General Perna, as you have stated before, 'a vaccine sitting on a shelf is not effective,'" the letter reads. "We couldn't agree with you more. That's why we are asking for your help now. When we work together, we can end this pandemic and return to a life of normalcy sooner."
The Trump administration has insisted it's necessary to hold back doses to ensure Americans who receive the first course of the two-dose vaccine will be sure to have access to a second dose. But the move has sparked a debate about whether a better strategy would be releasing all available doses as quickly as possible, particularly amid rising death and hospitalization rates. A study published Monday in the Annals of Internal Medicine also found that administering first doses of a Covid-19 vaccine to more individuals instead of withholding available supply for use as a second dose may reduce the number of new cases.
"Operation Warp Speed is continuing to ensure second doses are available to vaccine administration sites, at appropriate intervals, as directed by jurisdiction leaders," said a spokesperson for the Department of Health and Human Services. "We would be delighted to learn that jurisdictions have actually administered many more doses than they are presently reporting. We are encouraging jurisdictions to expand their priority groups as needed to ensure no vaccine is sitting on the shelf after having been delivered to the jurisdiction-directed locations."
The spokesperson also noted the US Food and Drug Administration recently reiterated the importance of requiring two doses for both the Pfizer and Modern vaccines.
More on the vaccines: The vaccines by Pfizer/BioNTech and Moderna are both about 95% effective after two full doses.
Earlier this week, two top officials from the FDA said anyone who receives those vaccines needs both doses, dismissing the idea of stretching the supply by allowing just one dose or cutting doses in half.
They also dismissed other ideas for stretching the vaccine supply and said people who are speculating about the possibility of making do with just one dose or cutting doses in half are misinterpreting the data.
"We have been following the discussions and news reports about reducing the number of doses, extending the length of time between doses, changing the dose (half-dose), or mixing and matching vaccines in order to immunize more people against COVID-19," FDA Commissioner Dr. Stephen Hahn and Dr. Peter Marks, who heads FDA's vaccine division, said in a statement.
"These are all reasonable questions to consider and evaluate in clinical trials. However, at this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence. Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19," they added.
Hahn and Marks also said the data supports giving the second dose of each vaccine at the specified interval — 21 days after the first dose for the Pfizer/BioNTech vaccine and 28 days after the first dose for the Moderna vaccine.
According to the study published in the Annals of Internal Medicine on Monday, by reducing the amount of the vaccine doses withheld to 10% for the first three weeks and supplying a steady dose of 6 million doses per week, the US could avoid up to 29% more cases over eight weeks.
The US government currently withholds 50% of the available vaccine supply, distributing to states and other jurisdictions weeks later to be administered as the second in a 2-dose series.
The researchers modeled various scenarios, with variables including vaccine supply, protection provided by the first dose and waning efficacy of the first dose if the second dose is delayed. Only in the unlikely worst-case scenario of a collapse in supply and minimal protection among individuals who have received the first dose would the model suggest that withholding 50% of available supply provides better protection.
"We find that under most plausible scenarios, a more balanced approach that withholds fewer doses during early distribution in order to vaccinate more people as soon as possible could substantially increase the benefits of vaccines, while enabling most recipients to receive second doses on schedule," write the study's authors, who were supported by the Canadian Institutes for Health Research and the US Centers for Disease Control and Prevention.
10:18 a.m. ET, January 8, 2021
The pandemic isn't slowing down as US reports record-high number of deaths. Here's where things stand.
From CNN's Amanda Watts and Elise Hammond
The pandemic in the US is showing no signs of slowing down. Yesterday’s sobering numbers marked the highest single day of reported Covid-19 deaths and the second highest single day of new cases.
The nation is currently at its highest peak for average daily new cases, average daily deaths and average number of current hospitalizations, even whiletesting remains well below its pre-holiday peak.
Here's a look at where things stand in the US:
Deaths
The US reported more than 4,000 Covid-19 deaths on Thursday, according to Johns Hopkins University data. The nation had never reached that milestone in a single day previously.
There is an average of 2,764 reported deaths per day, JHU data shows. This metric is also at a record-high.
At least 40 states are showing upward trends in Covid-19 cases this week compared to the previous week. Additionally, 34 states had a daily positivity above 10% over the last seven days.
The US saw at least 274,703 new cases on Thursday, according to JHU. That's the second highest single-day increase since the beginning of the pandemic.
The country is averaging about 228,497 new Covid-19 cases per day, which is up 22% from the previous week, JHU data shows.
Hospitalizations
There were at least 132,370 people reported to be in the hospital on Thursday, according to The Covid Tracking Project data. This is second highest number of current hospitalizations and the thirty-seventh consecutive day that metric has stayed above 100,000 people.
“Every single southern state has seen hospitalizations rise significantly since the middle of last month, and 13 states in the South set new records for Covid-19 hospitalizations in the past seven days,” according to CTP.
Vaccines
So far, there have been at least 21,419,800 vaccine doses distributed across the US and at least 5,919,418 vaccine doses administered, according to the CDC.
Across the US, the ratio of doses administered to doses delivered is at about 27.6%.
Only 3 states have administered more than 50% of the doses that were distributed, according to CDC
Here's a look at where cases are rising in the US:
Dr. Gupta explains why Covid-19 death projections keep increasing: