FDA shortens interval for Moderna's Covid-19 booster dose to 5 months

1 week ago 11
1 min ago

FDA shortens interval for Moderna's Covid-19 booster dose to 5 months 

From CNN's Naomi Thomas

Michael Stremfel, owner of the pharmacy, prepares a booster shot of Moderna vaccine for Covid19 at Flintridge Pharmacy on Tuesday, November 16, 2021 in La Cañada Flintridge, CA. Michael Stremfel, owner of the pharmacy, prepares a booster shot of Moderna vaccine for Covid19 at Flintridge Pharmacy on Tuesday, November 16, 2021 in La Cañada Flintridge, CA. (Irfan Khan/Los Angeles Times/Getty Images)

The US Food and Drug Administration on Friday amended the emergency use authorization for Moderna’s Covid-19 vaccine, shortening the period of time between initial vaccination and the booster shot to at least five months for those over the age of 18. 

“The country is in the middle of a wave of the highly contagious omicron variant, which spreads more rapidly than the original SARS-CoV-2 virus and other variants that have emerged,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in an FDA news release. “Vaccination is our best defense against COVID-19, including the circulating variants, and shortening the length of time between completion of a primary series and a booster dose may help reduce waning immunity. Today’s action also brings consistency in the timing for administration of a booster dose among the available mRNA vaccines. We encourage everyone to get vaccinated—it’s never too late to get your COVID-19 vaccine or booster.” 

The FDA has already shortened the time needed before receiving a booster shot of the Pfizer/BioNTech vaccine from six to five months. The Pfizer booster is authorized for everyone age 12 and older.

2 min ago

Tennis star Renata Voráčová held in same place as Novak Djokovic in Australia Covid-19 vaccine row

Fromm CNN’s Amy Cassidy

Czech women's tennis player Renata Voráčová is in the same immigration detention center as Novak Djokovic after having her visa canceled, a Czech Foreign Ministry spokesperson told CNN Friday.

“We can confirm that the Czech tennis player Renata Voráčová is in the same detention as Djokovič, together with several other tennis players, in Melbourne. Our Consulate General in Sydney is now dealing with the situation and is in touch with the tennis player,” a statement by the Ministry said.

“According to our information, she has proven non-infectious status in a way that entitles her to participate in the tournament. She has even played one match. For this reason, we have lodged a protest note with the Australian authorities through the Embassy in Canberra, asking them to explain the situation.

"However, Renata Voráčová decided to give up further participation in the tournament and leave Australia due to the limited possibility of training. Our embassy in Australia is assisting her in completing the formalities for leaving the country and will continue to be in contact with her in case of any complications,” the statement concluded. 

The Australian Border Force has confirmed three visas connected to the Australian Open have been canceled.

Novak Djokovic and Renata Voráčová remain in detention whilst one unnamed individual has already “voluntarily” left the country.

 Read more on this story here.

16 min ago

Japan to put 3 prefectures under quasi-state of emergency over Covid-19 cases rise

From Emiko Jozuka in Tokyo

Japanese Prime Minister Fumio Kishida attends a meeting for COVID-19 at the prime minister's office in Tokyo on January 7, 2022, amid continuing worries over omicron variant. Japanese government decides to issue the pre-emergency measures for Okinawa, Yamaguchi, and Hiroshima Prefectures. In 3 Prefectures, the number of newly infected COVID-19 is increasing rapidly. Japanese Prime Minister Fumio Kishida attends a meeting for COVID-19 at the prime minister's office in Tokyo on January 7, 2022, amid continuing worries over omicron variant. Japanese government decides to issue the pre-emergency measures for Okinawa, Yamaguchi, and Hiroshima Prefectures. In 3 Prefectures, the number of newly infected COVID-19 is increasing rapidly. (The Yomiuri Shimbun/AP)

Japan will place Okinawa, Hiroshima and Yamaguchi prefectures under a quasi-state of emergency from Sunday until Jan. 31 in response to a recent surge of coronavirus infections, Japanese Prime Minister Fumio Kishida has said.

A quasi-state of emergency allows local governors to impose stricter anti-virus measures, including curfews, alcohol bans and occupancy limits for restaurants.

This is the first time such measures were implemented since Kishida took office in October.

The rapid spread of infections could lead to a rise in serious cases, which would strain the medical system, Kishida told reporters on Thursday. "We have concluded that measures should be taken to contain the spread of infection," said Kishida.   

Okinawa, located 1,400 km (or about 900 miles) from Tokyo, is home to the majority of US military installations in Japan. It is among the worst-hit prefectures, reporting a record 981 daily local infections Thursday, according to local government data. On Thursday, an additional 162 daily cases were reported across US military bases, according to Okinawa government data.

Kishida told reporters Friday that he had instructed Foreign Minister Yoshimasa Hayashi to urge the US again to implement stricter measures against the virus at US military installations during a virtual bilateral ministerial meeting on Friday.

In response to the increased Covid-19 spread at US installations and across Japan, the US Forces Japan (USFJ) said it would toughen measures against the virus on Wednesday, with individual bases implementing further measures depending on their Covid-19 measures.

Marine Forces Japan re-instituted mask mandates for everyone on-base regardless of vaccination status on December 23, according to a post on the Marine Corps Community Service website. However, the mandate does not apply to those eating or actively exercising, including indoor cardio, organized athletics, and sports. USFJ said it requires three negative Covid-19 tests for those traveling to Japan and a 14 day “restriction of movement” upon arrival.

USFJ said it will continue to monitor and adjust COVID-19 mitigation measures in cooperation with the Japanese government.

The number of newly confirmed coronavirus cases topped 4,000 in the country Thursday — the first time since Sept. 18, according to Japan's public broadcaster NHK. However, the figures are still lower than many other nations, including the US, UK and France.

The president of the Japan Medical Association, Toshio Nakagawa, said that Japan has already "entered the sixth wave" of the pandemic at a press conference also on Thursday. He added that the rate at which new cases is rising is extremely fast.

5 min ago

Novak Djokovic thanks fans for "continuous support" amid Covid-19 visa row

From CNN’s Aleks Klosok 

(djokernole/instagram) (djokernole/instagram)

Novak Djokovic thanked people around the world Friday for their “continuous support” in the midst of the furor over the cancellation of the tennis star’s visa.

Djokovic posted a message in both Serbian and English on his Instagram story.

Writing in English, Djokovic said: "Thank you to people around the world for your continuous support. I can feel it and it is greatly appreciated."

It is the first public comments from Djokovic since he landed in Melbourne.

23 min ago

Hospital staff absences up nearly 60% in a week in England due to Covid-19, data shows

From CNN's Amy Cassidy in Glasgow

 Tuesday December 21, 2021. Medical staff wearing FFP3 face masks walk along a corridor at King's College Hospital, in south east London. Picture date: Tuesday December 21, 2021. (Victoria Jones/PA/Getty Images)

Hospital staff absences in England increased by almost 60% in the week up to Jan. 2, due to Covid-19 "sickness or self-isolation," data from the National Health Service shows.

The number shot up by 59% from 24,632 on Dec. 26 to 39,142 on Jan. 2, according to the latest figures published Friday.

Covid-19-related absences account for almost half of the total 82,384 hospital staff absences on Jan. 2, the data also shows. 

It comes as 200 troops have been deployed to support London hospitals amid the shortages, the Ministry of Defense announced Friday, as staff absences rose by 4% in the week up to Jan. 2.

However, the sharpest rise in staff absences occurred in the northern regions of England, now the epicenter of the country’s Omicron outbreak. Hospitals in the North West saw Covid-related staff absences rise by 85% compared to the previous week, while in the North East they almost doubled in numbers. 

56 min ago

CDC did not "pivot" isolation recommendations, but provided guidance for how to use tests, head says 

From CNN's Naomi Thomas

Dr. Rochelle Walensky, director of the US Centers for Disease Control and Prevention, talks to CBS Mornings on Friday 7 January 2022Dr. Rochelle Walensky, director of the US Centers for Disease Control and Prevention, talks to CBS Mornings on Friday 7 January 2022 (CBS)

Dr. Rochelle Walensky, director of the US Centers for Disease Control and Prevention, said on CBS Mornings Friday that the CDC didn’t pivot its recommendations around Covid-19 isolationbut instead provided guidance for those who chose to take an antigen test. 

“I remind you, isolation is for people who have had a positive test,” she said, when asked about changes to the isolation guidance. “We have now dozens of papers that are now on our CDC website that we’ve reviewed to update this guidance in the context of the science and the epidemiology of our time.” 

She said that it is known that for the one to two days prior to infection and two to three days after symptoms is the time when a person is maximally infectious. By day five, after symptoms, “most of that infectiousness, that contagiousness is really behind you,” she said. 

“That’s really where we say: Do you have symptoms? If your symptoms are better, you’re safe to go out as long as you’re wearing a mask all the time,” she said. “What we heard over the last week is many people were interested in using an antigen test, they had access to the antigen test.”

“So, we did not pivot our recommendations, what we did is we provided guidance for how you’d use and interpret that antigen test, if you so chose to take the extra step to get one,” she said. “And that is, if it’s positive, stay home. And if it’s negative, please continue to wear your mask, because that does not mean you’re no longer infectious.” 

Asked if tests would be required before leaving isolation if tests were widely available and if access was no object, Walensky said that “we require tests for leaving quarantine — quarantine being this period of time after you’ve been exposed. What I do want to say is that we have to provide guidance that is, you know, grounded in science, that is grounded in the epidemiology of our current moment in time and implementable at the state and local jurisdictional level.” 

“If they can’t get a test, they should wear a mask,” Walensky said, when asked what people who couldn’t get a test after the five days of isolation should do. “And that’s actually really what our guidance says, isolate for those first five days, after those first five days, make sure you’re feeling better, if you’re feeling better then you really can go out, but you need to go out and you need to be wearing your mask all the time.”  

Walensky also addressed criticism around communicating the guidelines, saying “we’re working 24/7, 12,000 people to keep America safe, to update our guidance in the context of really fast moving science and really fast moving epidemiology. We have room, we can improve in our communications of how we convey that science to the American people. We will continue to do so. We’ve gotten some criticism, but we’ve also gotten quite a bit of endorsement of these new guidance.” 

22 min ago

Australian Border Force: One visa canceled, another individual departs in connection with Australian Open

From CNN’s Aleks Klosok

The Australian Border Force (ABF) told CNN Friday that its investigation into the visa status of two individuals connected to the Australian Open has concluded, amid the furor over the cancelation of tennis superstar Novak Djokovic’s visa.

Separate to the ongoing saga of Djokovic's revoked visa, the ABF said one individual has voluntarily departed Australia following inquiries. The ABF confirmed that the visa of another unnamed individual has been canceled.

This person has been taken into immigration detention pending their removal from Australia,” the ABF said in a statement.

“All travelers who enter Australia must do so in accordance with our strict laws and entry requirements, regardless of their status or their reasons for entering the country,” the ABF added.

Australian media outlets reported on Friday that the second canceled visa is that of Czech women's tennis player Renata Voráčová.

Australian national broadcaster ABC reports that Voráčová was told by ABF officials that she must soon leave the country, although it’s unclear at this stage whether or not she intends to appeal the decision.

According to The Age newspaper, the former Wimbledon doubles semi-finalist entered Australia with a medical exemption on the basis she had been infected with Covid-19 in the last six months.

CNN has not been able to independently verify those reports.

The 38-year-old has already played in a warm-up tournament in Melbourne, having lost in the first round of the women’s doubles competition at the Melbourne Summer Set tournament.

Neither Tennis Australia nor Voráčová’s representatives were immediately available for comment when contacted by CNN.

1 hr 5 min ago

Airlines cancel more than 2,200 US flights on Friday

From CNN's Gregory Wallace

People wait in line to check in at the George Bush Intercontinental Airport on January 06, 2022 in Houston, Texas. Airlines across the country have cancelled more than 1,000 flights for the 11th straight day, marking the airline industry's worst stretch since the beginning of the COVID-19 pandemic. Airlines have also reported struggling with staff shortages amidst the surge of the COVID-19 Omicron Variant. People wait in line to check in at the George Bush Intercontinental Airport on January 06, 2022 in Houston, Texas. Airlines across the country have cancelled more than 1,000 flights for the 11th straight day, marking the airline industry's worst stretch since the beginning of the COVID-19 pandemic. Airlines have also reported struggling with staff shortages amidst the surge of the COVID-19 Omicron Variant. (Brandon Bell/Getty Images)

Airlines canceled more than 2,200 US flights on Friday amid the continued impact of the Omicron coronavirus variant, including many on the East coast where another winter storm has compounded difficulties.  

The cancelations, as reported by the aviation tracking website FlightAware, included more than 500 by Southwest Airlines, with a heavy presence in Baltimore, and more than 150 by Northeast-focused JetBlue Airways.  

The latest wave pushed the total cancelations by all airlines since Christmas Eve to over 27,000 US flights. Friday was the fifth day in that period to top 2,000 cancelations.  

The chaos stretched from Boston, where FlightAware said 31% of flights were canceled, to New York -- 35% at LaGuardia, 20% at JFK, and 20% at Newark -- and south to the DC area, where FlightAware reported 20% at Reagan National and 17% at BWI Marshall were canceled.  

LaGuardia told passengers in a social media post “to only go to the airport if your airline has confirmed your flight.” Reagan National reported that its “snow team worked through the night to clear the main runway, which is open for flights.”  

1 hr 32 min ago

The US needs variant-specific coronavirus vaccines, former Biden health adviser says

From CNN Health’s Naomi Thomas

Rick Bright, a former health adviser to President Joe Biden, said on CNN’s New Day Friday that using all the tools available in the United States will help the country control the coronavirus in the same way as flu, but that updated versions of vaccines to match variants are needed. 

Bright, the former director of the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, was a co-author of one of three editorials published Thursday in the Journal of the American Medical Association (JAMA) that discussed a strategy to help the US face a “new normal” when it comes to Covid-19. 

“We’re entering year three of this pandemic and we’re becoming increasingly convinced that this virus -- the SARS-CoV-2 virus that causes Covid -- is going to be with us for a very, very long time,” Bright said, when asked what "the new normal" would look like. It would be similar to what was seen with influenza after the 1918 and 2009 H1N1 pandemics, he added.

He said the world has learned to live with influenza as a result of the tools we have to control it and "that's what we anticipate is going to happen with SARS-CoV-2."

“So our new normal will look like a future where we have SARS-CoV-2 but it’s not a panic, it’s not a crisis, it’s not devastating our public health infrastructure and our economy the way we see it today," he added.

Bright said that the US has “amazingly sharp tools” and if they are used appropriately, as is laid out in the JAMA articles, then the coronavirus can be controlled in the same way as influenza. 

Asked what the Biden administration needs to do on vaccines, Bright said “we’re continuing to use a vaccine that is over two years old, and the virus has continually changed.” 

“We need to harness the full power of those tools that we used to make the Johnson & Johnson and the Pfizer, Moderna vaccines, we need to sharpen those tools against the virus as it changes,” he said. “Right now, we’re seeing one arm of our immunity become weakened because the virus has changed. If we update our vaccines to match the Omicron variant, not only can we reestablish both arms of powerful immunity, but we can also be better prepared for the next change of the virus.”

He continued: “That’s what we do with influenza and that’s what we should be doing with SARS-CoV-2."

Bright also said that the reason this hasn’t happened is largely because people are learning as they go. 

“I don’t think many people anticipated the virus would change as rapidly and as much as it has,” he said. “So it’s a new virus, and we’re learning about it, but it has shown us that capability now, when it changed from the original strain to Alpha to Beta to Delta and now Omicron, so now we need to, with humility, respect this virus, understand its capability and use what we know about vaccines and stop the virus.” 

When asked if the Biden administration response has been insufficient, Bright said its sole focus has been on making sure that people get vaccinated, which he said was a really important goal.

“I do think that they have been overwhelmed and they’ve been caught off guard by the virus as it changes,” he said. “I think there’s a lot for the administration to try to tackle in handling a pandemic, and they need to acknowledge that there are other things that need to happen in parallel. They need to broaden their approach, use all the tools that we have together, and together we can stop this virus.” 

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