FDA issues emergency use authorization for Moderna's Covid-19 vaccine
From CNN's Ben Tinker and Arman Azad
The US Food and Drug Administration has authorized Moderna's Covid-19 vaccine for emergency use in the United States.
The FDA made its announcement on Twitter Friday night, following the recommendation of its Vaccines and Related Biological Products Advisory Committee on Thursday.
“The emergency use authorization allows the vaccine to be distributed in the U.S for use in individuals 18 years and older,” the FDA tweeted. "The FDA has determined that the #COVID19 vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence it may be effective in preventing #COVID19."
Read the tweet:
6:32 p.m. ET, December 18, 2020
US State Department has received its first allotment of the Covid-19 vaccine
From CNN's Jennifer Hansler
A State Department spokesperson said Friday that the department “has received its first small allotment” of the Covid-19 vaccine “and expects to receive its remaining allotment incrementally.”
“The first limited number of vaccines will be made available to department medical personnel, mission-critical diplomatic security personnel in the national capital region, personnel supporting the department’s 24/7 watch centers, critical operations, maintenance, and custodial staff, and American personnel in Kabul, Baghdad, and Mogadishu given local conditions that can exacerbate the disease burden and the challenges of providing medical support services in these locations,” the spokesperson said.
The spokesperson told CNN that due "to operational sensitivity, the department is not publicly sharing specific details of the timing or logistics of the deployment of the Covid-19 vaccine for state’s workforce at this time.”
6:29 p.m. ET, December 18, 2020
Italy will enforce strict Covid-19 restrictions over the holidays
From CNN's Nicola Ruotolo and Mia Alberti
Italy will enforce its strictest level of Covid-19 measures nationwide over the Christmas and New Year's Day period to avert the risk of a third wave of coronavirus infections.
Prime Minister Giuseppe Conte announced on Friday that the entire country will be declared a virus "red zone" between Dec. 24 and Dec. 27, and on Dec. 31 and Jan. 1-6.
The restrictions mean residents can only leave their houses for health or work reasons or to cover essential needs, such as exercise or grocery shopping. Residents can also go out to visit a maximum of two non-household family members between the hours of 5 a.m. and 10 p.m. Meaning households can host two extra family members on Christmas Eve.
Churches must close by 10 p.m., which rules out the traditional midnight mass for millions of Catholics in Italy. Health Minister Sandra Zampa had said the Christmas Eve mass must end by around 8:30 p.m., "so that worshippers can return home before the 10 p.m. curfew."
During these days, all shops, bars and restaurants will be closed except for delivery and take out.
The country's risk level will be lowered to an "orange zone" on Dec. 28, 29, 30 and Jan. 4. That means residents will be allowed to travel only within their towns. A curfew will still be in place between 10 p.m. and 5 a.m.
In this period, shops may open until 9 p.m. but bars and restaurants must remain closed.
Approximately 645 million euros (about $790 million) will be set aside to support the catering industry, the prime minister said, adding that other activities hit by the strict measures will be eligible to access government funds.
6:18 p.m. ET, December 18, 2020
California reports at least 300 Covid-19 deaths for second straight day
From CNN's Sarah Moon
California reported 300 new coronavirus-related deaths on Friday, according to data from the California Department of Public Health (CDPH), marking the second straight day the state has reported at least 300 lives lost.
The latest death toll comes after California reported 379 deaths from Covid-19 on Thursday, its highest figure in a single day, and as a growing number of hospitals report zero intensive care unit capacity available.
More than 41,000 new cases were added on Friday as the state continues to see an unprecedented surge in new infections following Thanksgiving, though state health officials noted some of the cases occurred “prior to yesterday.”
“As case numbers continue to rise in California, the total number of individuals who will have serious outcomes will also increase,” CDPH said in a news release.
Hospitalizations have also increased in the state, with 16,019 people being treated and 3,447 Covid-19 patients in ICUs. The skyrocketing number of new cases has caused ICU bed capacity in Southern California and the San Joaquin Valley to fall to 0.0%.
To date, California has reported a total of 1,764,374 cases and 21,160 deaths. As of Friday, the seven-day positivity rate is 12.8% and the 14-day positivity rate is 11.8%, the highest figures reported in the state since the spring.
Note: These numbers were released by the California Department of Public Health and may not line up exactly in real-time with CNN’s database drawn from Johns Hopkins University and the Covid Tracking Project.
6:16 p.m. ET, December 18, 2020
New Jersey will open six "vaccine mega-sites" in January
From CNN’s Evan Simko-Bednarski
New Jersey will open six vaccine "mega-sites" in January, in service of the state's efforts to vaccinate 70% of its population within six months, Gov. Phil Murphy announced Friday.
The sites will be distributed across the state, and will be in place to assist ongoing efforts to vaccinate frontline health care workers early in the new year.
New Jersey Health Commissioner Judy Persichilli said Friday that the state's efforts to quickly vaccinate an estimated 4.7 million Garden State residents will hinge on vaccine availability.
"We expect demand will outpace supply," she said.
Persichilli said that the supply of doses from the federal government was already falling short of expectations.
"The previously expected second tranche of Pfizer doses for next week was expected to be 86,775," she said. "Now, based on what is entered into the federal 'Tiberius' platform, we see we are expecting only 53,625. That’s a reduction of 38%."
Persichilli added that the total expected dosages to be delivered to New Jersey in the month of December had been revised downward by 33%, according to the federal database.
Murphy said he had yet to get a satisfactory reason why New Jersey, along with every other state, was slated to get fewer doses of the Covid-19 vaccine than initially expected.
"I spoke with Pfizer," he said. "They have no idea why this is being done."
"Pfizer said to me, personally, 'we want you to know this is not us,'" Murphy said, adding that he will bring up the issue on a call with the White House this weekend.
New Jersey reported an additional 3,975 infections on Friday, along with 44 deaths. Hospitalizations went down for the second day in a row, with at least 3,582 patients hospitalized with confirmed or suspected Covid-19 as of Thursday night.
"These numbers have begun moving in the right direction, which is down," Murphy said before adding, "two days certainly do not make a trend."
Note: These numbers were released by New Jersey's public health agency, and may not line up exactly in real time with CNN’s database drawn from Johns Hopkins University and the Covid Tracking Project.
5:15 p.m. ET, December 18, 2020
Third case of Covid-19 vaccine-related anaphylaxis reported in Alaska
From CNN’s Jessica Firger
A clinician in Fairbanks, Alaska, who received a coronavirus vaccine on Thursday experienced what appeared to be an anaphylactic reaction, according to leadership at Foundation Health Partners (FHP), a health care system linked to Fairbanks Memorial Hospital.
The employee reported she had no known allergies, though she had once experienced a reaction to a bee sting. Ten minutes after receiving the Pfizer/BioNTech vaccine, the woman began having what is described as “traditional anaphylactic symptoms,” which included tongue swelling, a hoarse voice and difficulty breathing.
While the vaccine clinic is stocked with first aid for anaphylaxis, it was not needed. Instead, the woman was taken to Fairbanks Memorial Hospital, and clinicians administered two doses of epinephrine. She remained at the hospital for observation and was released six hours later. She was one of nearly 300 employees to receive the vaccine on Thursday; their first shipment of vaccines arrived on Wednesday.
The employee, who wished to remain anonymous, issued a statement:
“Anaphylaxis is a rare but expected potential side effect that is treatable and does not have long term health implications like Covid. I would get the vaccine and recommend it to anyone, despite my reaction, to help our country get immunized which is needed for the health of all Americans, for the economy, get families hugging again, for getting children back to schools, and to get the country on the other side of this pandemic. I’ve seen firsthand the suffering and death of COVID patients and my adverse reaction to the vaccine pales to what COVID infection can do to people.”
It is not surprising that there have been reports of anaphylaxis associated with the coronavirus vaccine. With more and more vaccines being administered every day, reports of adverse reactions will become more common, though they are still few and far between.
Officials at FHP say they are “working with the State of Alaska Department of Health and Human Services and the Centers for Disease Control and Prevention (CDC) to share details of the reaction. The Food and Drug Administration (FDA) and the CDC have created several programs for tracking any adverse reactions to the vaccine. FHP reported details of yesterday’s event to the Vaccine Adverse Event Reporting System (VAERS). This national system collects and analyzes data that helps federal health authorities monitor the safety of vaccines.”
4:46 p.m. ET, December 18, 2020
Extra doses in Pfizer/BioNTech Covid-19 vaccine vials are safe and should be used, FDA says
From CNN's Lauren Mascarenhas
The extra doses in Pfizer/BioNTech Covid-19 vials are safe and should be used, US Food and Drug Commissioner Dr. Stephen Hahn said Friday.
It’s possible to squeeze out extra doses of Pfizer’s vaccine from the vials, if there is solution remaining in them after the standard five doses are given, the FDA said earlier this week.
“It's safe to use,” Hahn said in an interview with Michael Toscano on the “First Light” podcast. “If the appropriate dosage is in there, the volume for the vaccine, it should be used, and we have no concerns about that.”
Hahn said that it’s not uncommon for extra solution to be in vaccine vials.
“It's a very common thing,” he said. “There’s always some overage that occurs, just to make sure that there's enough for the doses that are said to be within the vial.”
It’s important to plan for anyone who receives one vaccine dose to get a second, Hahn said.
“If you want the 95% protection, the clinical trial shows that the two-dose regimen, 21 days apart, is what you need,” he said. “But given that this overage is in the vials, we believe that that can be factored into subsequent calculations.”
4:34 p.m. ET, December 18, 2020
Colorado governor calls on federal government to get Covid-19 vaccines distributed
From CNN's Nakia McNabb
Colorado Gov. Jared Polis said Covid-19 numbers remain high overall and has called for continued action to prevent the spread of the virus.
Polis announced 3,693 new cases of Covid-19, saying the positivity rate continues to show improvement at 7.19% but the goal is to get it below 5%.
During a news conference today, Polis said Colorado received its first shipment of the Pfizer vaccine on Monday and is expecting its first shipment of the Moderna vaccine next week.
Polis said with the good news of additional shipments of vaccine, there is also bad news. According to Polis, the number of doses Colorado will receive from Pfizer will be lower next week because of Pfizer's announcement that the federal government needs to tell them where to ship the vaccine.
"I do call upon the federal government as I saw Pfizer's announcement that they had doses waiting in the warehouse and they just needed to be told where to send them. We say send them to Colorado, but we encourage the federal government to get those distributed out. They're not doing any good in a Pfizer warehouse," Polis said.
The governor said that health officials have notified him that starting today, the Pfizer vaccine will have six doses instead of five, increasing the number of vaccines by 20%.
"We are comfortable moving forward with the assumption that six doses is the norm per vial and so the numbers that the state reports on Pfizer vaccine will show a different number than what the CDC says they are sending us," Polis said.
4:10 p.m. ET, December 18, 2020
US Supreme Court justices eligible to receive coronavirus vaccine soon
From CNN's Ariane de Vogue
The justices of the US Supreme Court are eligible to receive the coronavirus vaccine in the coming days, a court spokesperson said.
The court has been informed by the Office of the Attending Physician that the justices are eligible to receive the vaccine in the coming days, the spokesperson told CNN.