Health

Gel packs tied to ‘potentially compromised’ COVID-19 vaccines across states: officials

Gel packs used for maintaining COVID-19 vaccine temperatures during transport are again in question amid potentially ruined jabs.

As states clamor for more supply, shipments of the Moderna vaccine have arrived at sites at out-of-range temperatures, affecting 4,400 doses in Maine and another 11,900 doses in Michigan earlier this week.

Both instances involve the same distributor — McKesson — and Moderna and federal officials are working on a full analysis on implications for viability of the vaccines, according to Dr. Nirav Shah, director of the Maine Center for Disease Control (CDC).

BIDEN PLAN TO REOPEN SCHOOLS SUBJECT TO POTENTIAL CHANGES IN CORONAVIRUS PANDEMIC, OFFICIAL SAYS

NC National Guard Dec. 30 tweet: “#NCNG received the first allocation of the Moderna COVID-19 vaccine. Our medics will begin providing the voluntary vaccine shots to Guardsmen currently supporting our state’s #COVID19NC response efforts after completing the prescribe vaccine training in the coming week.”
(NC National Guard)

“This phenomenon of some doses arriving out of the temperature range happened not just in Maine, but also in some other states, for example, in Michigan,” Shah said at a virtual briefing Thursday.

Shipments come along with a temperature monitoring device to track temperatures during transport. Shah said the boxes arrived in Maine with a “red X” instead of a “green checkmark.”

McKesson previously told Fox News it learned of the issue on Monday, and pinned the problem among faulty gel packs used to keep the doses cold.

“We also identified the root cause of the issue – some of the gel packs used to maintain appropriate temperatures during shipping were found to be too cold – and have taken steps to prevent this from occurring in the future,” reads an emailed statement from McKesson.

Moderna’s vaccine is stable at minus 20 degrees Celsius, but cannot dip to storage temperatures lower than minus 40 degrees Celsius. Once refrigerated, it can last 30 days at 2 degrees Celsius to 8 degrees Celsius. Vials cannot be refrozen once thawed.

McKesson told the U.S. CDC and Operation Warp Speed that “gel packs were not left out to be thawed to appropriate temperature, but rather were just tossed into the boxes,” according to Shah. “So the operating hypothesis right now is that the temperature exceedance was on the low end, not on the high end,” but until an investigation is complete, officials won’t know for sure, he added.

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Replacement doses have already been shipped out to both states, but not without some delays in appointments.

None of the vaccines in question have been administered, Shah said, but instead are being held roped off in frozen storage until scientists greenlight the vaccines as safe and effective for use.

“Being too cold increases the chances that the vaccines that were delivered to Maine, those 4,400 doses can eventually be used,” Shah said. “That’s because vaccines of this sort are generally more stable in cold environments.”

Overall, Maine has administered more than 92,000 doses, and over 17,000 people in the state have already received their second dose.

FDA approves 1st long-acting HIV drug combo, monthly shots

U.S. regulators have approved the first long-acting drug combo for HIV, monthly shots that can replace the daily pills now used to control infection with the AIDS virus.

Thursday’s approval of the two-shot combo called Cabenuva is expected to make it easier for people to stay on track with their HIV medicines and to do so with more privacy. It’s a huge change from not long ago, when patients had to take multiple pills several times a day, carefully timed around meals.

“That will enhance quality of life” to need treatment just once a month, said Dr. Steven Deeks, an HIV specialist at the University of California, San Francisco, who has no ties to the drug’s makers. “People don’t want those daily reminders that they’re HIV infected.”

FAUCI SAYS WORKING UNDER BIDEN ADMINISTRATION ‘LIBERATING’

Cabenuva combines rilpivirine, sold as Edurant by Johnson & Johnson’s Janssen unit, and a new drug — cabotegravir, from ViiV Healthcare. They’re packaged together and given as separate shots once a month. Dosing every two months also is being tested.

The U.S. Food and Drug Administration approved Cabenuva for use in adults who have had their disease well controlled by conventional HIV medicines and who have not shown signs of viral resistance to the two drugs in Cabenuva.

The agency also approved a pill version of cabotegravir to be taken with rilpivarine for a month before switching to the shots to be sure the drugs are well tolerated.

U.S. regulators have approved the first long-acting combo drug for HIV, monthly shots that can replace the daily pills that have been used for decades to control infection with the AIDS virus.
(ViiV Healthcare via AP))

ViiV said the shot combo would cost $5,940 for an initial, higher dose and $3,960 per month afterward. The company said that is “within the range” of what one-a-day pill combos cost now. How much a patient pays depends on insurance, income and other things.

Studies found that patients greatly preferred the shots.

“Even people who are taking one pill once a day just reported improvement in their quality of life to switch to an injection,” said Dr. Judith Currier, an HIV specialist at the University of California, Los Angeles. She consults for ViiV and wrote a commentary accompanying one study of the drug in the New England Journal of Medicine.

Deeks said long-acting shots also give hope of reaching groups that have a hard time sticking to treatment, including people with mental illness or substance abuse problems.

DAVE CHAPELLE TESTS POSITIVE FOR COVID-19

“There’s a great unmet need” that the shots may fill, he said.

Separately, ViiV plans to seek approval for cabotegravir for HIV prevention. Two recent studies found that cabotegravir shots every two months were better than daily Truvada pills for keeping uninfected people from catching the virus from an infected sex partner.

Fauci says working under Biden administration ‘liberating’

When fielding questions on the Biden administration’s plan to tackle the ongoing coronavirus pandemic, the nation’s top infectious expert said he feels free to “let the science speak” under the new administration — which he described as a “liberating feeling.”

Shortly before departing the podium during an appearance at a White House press briefing on Thursday afternoon, Dr. Anthony Fauci was asked by a reporter if he feels “less constrained” under the new administration.

Though hoping to avoid “going back over history,” Fauci said, “it was very clear that there were things that were said, be it regarding things like hydroxychloroquine and other things like that — that really was uncomfortable because they were not based on scientific fact,” he said, referring to former President Trump’s controversial comments on the malaria drug which he made not long after the pandemic began.

“I can tell you I take no pleasure at all in being in a situation of contradicting the president, so it was really something that you didn’t feel you could actually say something and there wouldn’t be any repercussions about it,” continued Fauci. “The idea that you can get up here and talk about what you know, what the evidence and science is, and know that’s it — let the science speak, it is somewhat of a liberating feeling.”

US VOWS TO AID WHO IN CORONAVIRUS RESPONSE: FAUCI

Fauci, the director of the National Institute of Allergy and Infectious Diseases and newly appointed chief medical adviser to Biden, added that his commitment to transparency is why he “got in trouble sometimes” when Trump was still in office.

“One of the things that was very clear as recently as about 15 minutes ago when I was with the president, is that one of the things we’re going to do is be completely transparent open and honest,” Fauci said during the briefing. “If things go wrong, not point fingers but correct them, and to make everything we do be based on science and evidence. That was literally a conversation I had 15 minutes ago with the president, and he has said that multiple times.”

Additionally, Fauci noted that the new administration would not be “starting from scratch” in terms of a coronavirus vaccine distribution effort. His comments contradict a CNN report that suggested otherwise.

“We’re certainly not starting from scratch because there is activity going on in the distribution. But if you look at the plan that the president has put forth about the things he is going to do — namely get community vaccine centers up, get pharmacies more involved … it’s taken what’s gone on, but amplifying it in a big way,” he said.

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The infectious disease expert also said that President Biden’s goal to vaccinate 100 million Americans in the administration’s first 100 days is “quite a reasonable goal.”

Reiterating past remarks, Fauci said if 85% of the country is vaccinated by the end of the summer, “we will be approaching a degree of normality” by the fall.

California woman says coronavirius infected entire family, killed her father: ‘This was a shock to all of us’

A California woman is pleading with others to remain diligent in protecting themselves and loved ones against the novel coronavirus after she and eight other members of her family contracted the disease, including her father, who was killed by it.

“My dad was healthy, he was active — he was an avid falconer, he had no underlying health issues,” Vanessa Avellaneda told local news outlet Fox 11 of her father, Jose Avellaneda, 58. “He ate [healthily], he was active, he was everything you look to be when you’re that age, and it affected him that it shouldn’t have, according to who is high risk and who is not.”

The Avellaneda family.
(Courtesy of XXX family via Fox 11)

In addition to her father and herself, Avellaneda said her husband, their four children, her mother and her cousin contracted the virus in November despite heeding many of the precautionary measures recommended by experts since the start of the pandemic.

“We got our groceries delivered, we didn’t go out, didn’t interact with people outside our home. So this was a shock to all of us, to say the least,” she told Fox 11.

CORONAVIRUS AND ‘DOUBLE MASKING’: ARE TWO FACE COVERINGS BETTER THAN ONE?

Jose Avellaneda in the hospital. (Courtesy of Avellaneda family via Fox 11)

The mom of four said she feels frustrated when she sees others not taking the pandemic seriously — especially after her family witnessed the devastating effects the virus can have first-hand.

“Seeing so many people online [asking], ‘Where can I eat dinner? Where can I get my nails done?’ This isn’t a time to be worrying about that. I just want everybody to take it seriously, this is not something I want anybody to feel,” she said.

Speaking of her father, Avellaneda remembered the 58-year-old was “always with a smile on his face.”

Jose Avellaneda with some of his family.
(Courtesy of Avellaneda family via Fox 11)

ALABAMA’S COVID-19 VACCINATION EFFORTS RANKED LAST IN US: CDC

“[He was] always willing to help anybody, actively involved in church, always there for our community,” she said.

“This has impacted us more than anybody can imagine, my dad being the sole provider for my mom and my cousin, this goes beyond politics, this is no longer politics, this is people’s health and their lives. Money can always be made just please adhere to the guidelines, it’s not worth losing a family member,” added Avellaneda.

Butternut squash products recalled over listeria contamination concerns

A variety of butternut squash products are facing a recall over concerns they are contaminated with listeria, according to a recall notice posted to the U.S. Food and Drug Administration (FDA) website this week.

In a recall notice shared on Tuesday, Lancaster Foods, LLC., said it is recalling several of its processed butternut squash products produced in several states, including North Carolina, Virginia, Washington, D.C., Maryland, Pennsylvania, New York, New Jersey, Connecticut, Rhode Island, Massachusetts, New Hampshire and Vermont.

“Out of an abundance of caution, Lancaster Foods has temporarily halted production of these items as the FDA and the company investigate the source of the issue,” reads the recall notice. “Consumers who have purchased units noted above are urged to return them to the place of purchase for a full refund.”

No illnesses have been reported to date, however.

SELECT PEPPERONI HOT POCKETS RECALLED OVER COMPLAINTS OF GLASS, PLASTIC IN PRODUCT

Listeriosis is a serious infection typically caused by eating food contaminated with Listeria monocytogenes, according to the Centers for Disease Control and Prevention (CDC).

Listeriosis can cause a variety of symptoms, and some groups — namely “young children, frail or elderly people, and others with weakened immune systems,” per the FDA — are at higher risk of severe illness.

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For pregnant women, symptoms of invasive listeria may present as fever or other flu-like symptoms, and can also cause miscarriage, stillbirth, premature delivery, or life-threatening infection of the newborn. In non-pregnant patients, symptoms often include headache, stiff neck, confusion, loss of balance and convulsions.

A full list of recalled products can be found here.

Coronavirus variants pose reinfection risk, scientists say

Those who recover from coronavirus infection have immunity for at least five to six months, per several early studies, and while re-infections to prior strains were rare, new mutated strains pose a risk of contracting the novel virus again, scientists say.

One researcher has even pinned a recent case surge in Manaus, Brazil, a northwestern city in the Amazon, to re-infections fueled by a variant strain called P.1, per NPR.

While research suggests the city already reached the herd immunity threshold, with over 70% of the population infected by last fall, the area’s health system is now collapsing amid an increase in infections and dwindling oxygen supplies.

US VOWS TO AID WHO IN CORONAVIRUS RESPONSE: FAUCI

The strain was recently made known, and scientists say it was circulating in Manaus in December. This strain shares several mutations with a variant initially detected in South Africa — which was said to “escape” neutralization power from antibodies in convalescent plasma treatment. A team of researchers tested convalescent plasma from coronavirus patients against the 501Y.V2 strain, and 48% of 44 samples “had no detectable neutralization activity,” study authors wrote. The paper upheld the risk of reinfection as well, writing: “These data highlight the prospect of reinfection with antigenically distinct variants and may foreshadow reduced efficacy of current spike-based vaccines.”

“We know that you can get reinfected even with the same version of the virus,” Ravi Gupta, virologist at the University of Cambridge, told NPR, though it is too early to say how often the reinfections may occur.

Last summer, Maria Van Kerkhove, WHO’s COVID-19 technical lead, addressed reinfection after the first documented case out of Hong Kong, saying: “It doesn’t mean that it’s happening, you know, a lot. We know that it’s possible. But it is something that we knew could be possible based on our experience with other human coronaviruses.”

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The case involved a man who was returning to Hong Kong after a trip to Spain when researchers from the University of Hong Kong said he tested positive for the virus during a screening at the airport, according to the Japan Times. Using genomic sequencing, the researchers were reportedly able to detect that the patient was infected by two different strains of the coronavirus.

Marcus Vinicius Lacerda, an infectious disease doctor at the Fundação de Medicina Tropical Doutor Heitor Vieira Dourado in Manaus, told NPR he believes reinfections are fueling the ongoing outbreak in the the Brazilian city.

However, researchers are working to confirm unknowns behind variant strains, such as their impact on efficacy of the recently approved vaccines, therapies and virus transmissibility.

The Associated Press contributed to this report.

Biden plan to reopen schools subject to potential changes in coronavirus pandemic, official says

One of President Biden’s goals for his first 100 days in office is to see to it that most schools are reopened for in-person learning, but after previewing one of the 10 coronavirus-related executive orders, the administration’s testing czar conceded the timeline may be adjusted as needed.

“The health and safety of students, educators, staff and families is paramount,” Carole Johnson, who was picked by Biden to lead the nationwide testing program, said during a call on Wednesday. “The administration will always be honest about the challenges we face, including addressing how and whether changes in the pandemic may impact the reopening of schools or the ability of schools to reopen.”

Biden is ordering the departments of Education and Health and Human Services to provide clear guidance for reopening schools and is enabling states to tap FEMA’s Disaster Relief Fund to help get the doors reopened. Administration officials have said that it will also require a better approach to vaccinations and an increase in testing, which has been a trouble point for the country since the outbreak began.

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“We do not have nearly enough testing capacity in this country,” Jeff Zients, the White House official charged with directing the nation’s COVID-19 repose, told the Associated Press. “We need the money in order to really ramp up testing, which is so important to reopen schools and businesses.”

Dr. Anthony Fauci, the nation’s leading infectious disease expert, has previously called for schools to remain open even as the coronavirus numbers spike.

“Our default position – there will always be exceptions … there is never one-size-fits-all – our default position should be to try to keep the schools open and get children who are not in school back in school as best as we possibly can,” Fauci said during a Harvard T.H. Chan School of Public Health forum in December.

He cited Centers for Disease Control and Prevention (CDC) data and studies that show the level of transmission in schools remains low, and that the real risk remains to be community spread.

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“When you take into consideration the safety and the health of the children as well as the teachers, in general, it looks like we can keep the children in school and get them back to school safely,” he said.

Fauci, similar to Zients, has also said that speeding the vaccination process would make it easier to keep schools open as the level of transmission in communities is lowered. However, vaccinating children has not yet begun, and there is not enough data to evaluate the safety and effectiveness in either of the currently approved jabs for younger students.

Under the Trump administration, states were tasked with coming up with their own distribution plans, which saw teachers included among essential workers but potentially placed in a lower tier in some regions rather than other. In New Jersey for instance, smoking was considered a chronic health condition which saw smokers become eligible for the vaccine ahead of teachers.

CLICK HERE FOR COMPLETE CORONAVIRUS COVERAGE

States are also reporting shortages in vaccine supply, which Biden’s new CDC director said will be addressed by working through manufacturing bottleneck issues and plans to invoke the Defense Production Act to ramp up supply.

The Associated Press contributed to this report.

Alabama to remove COVID-19 vaccine from providers who don’t administer jab in ‘timely way’: officials

Just days after Alabama’s COVID-19 vaccination efforts were ranked last in the U.S., health officials in the state announced a new policy in an effort to speed the rollout: if providers don’t use the doses made available to them as quickly as possible, the already-limited supply will be removed and sent elsewhere in the state where they can be administered “in a timely way.”

“In response to concerns that some providers are failing to administer their allotments of vaccine on a timely basis, [Alabama Department of Public Health] will begin removing vaccine supplies from providers who are not administering vaccine in a timely way,” officials with the Alabama Department of Public Health (ADPH) said in a news release on Wednesday.

“Unused vaccine will be redirected to other providers who will administer vaccine faster. ADPH is surveying all providers in the state to ensure that all administered doses have been properly reported to us, and to determine whether there is any available vaccine that needs to be redistributed elsewhere.”

Currently, county health departments are required to administer “all inventory of vaccine each week until no vaccine remains,” ADPH officials said.

CORONAVIRUS AND ‘DOUBLE MASKING’: ARE TWO FACE COVERINGS BETTER THAN ONE?

“With an understanding that some smaller rural counties may not be able to give vaccine at that volume, ADPH is partnering with community providers to rapidly get vaccine out to the public,” they said. To assist with such efforts across counties, ADPH employees “have been redirected from their existing duties.”

Currently, the Centers for Disease Control and Prevention (CDC) vaccine tracker shows that Alabama has fallen behind the rest of the country in terms of vaccination efforts, averaging just over 2,800 shots per every 100,000 residents as of Wednesday.

The state, which on Monday opened up appointments for residents 75 and older and first responders in addition to health care workers, has administered some 139,200 of the 483,275 doses distributed, federal estimates also show.

There is a discrepancy between state and federal estimates, however.

The ADPH data dashboard currently shows that more than 200,000 doses have been administered to date.

Alabama health officials said in the news release that the department is working with the federal health agency to “resolve data issues.”

ALABAMA’S COVID-19 VACCINATION EFFORTS RANKED LAST IN US: CDC

“Contrary to some reports, the number of unused doses from previous allocations does not affect the quantity of doses that the [CDC] authorizes for Alabama. ADPH is working with CDC to resolve data issues to ensure that Alabama receives credit for every dose administered in the state,” the release reads.

“No vaccine doses in Alabama have been discarded, and allocations are population-based so there is no advantage for residents of larger counties over smaller ones,” they added.

In a statement, Dr. Scott Harris, the state’s health officer, attempted to clarify the “misunderstandings” regarding vaccine efforts in Alabama.

“Every person who receives a COVID-19 shot is deserving of one and will receive it, as we are determined to make sure that no vaccine is sitting unused on the shelf. We are making every effort to get shots into arms as quickly as possible,” he said. “The biggest obstacle to vaccination is still the limited vaccine supply. We are attempting to manage expectations because the timeline for receipt of vaccine has not changed and we cannot give people a resource we don’t have yet.”

CLICK HERE FOR COMPLETE CORONAVIRUS COVERAGE

The state’s new policy to speed vaccination efforts follows similar threats made in New York by the state’s Gov. Andrew Cuomo. The governor on Monday said that hospitals that have administered their allocated doses quickly will receive more, while those who have been slow to use up their doses will not be allocated additional ones.

“For the lower performing facilities, we are going to give them less, if any, of the new allocation. They’ll all have enough to do their staff, but we want to make sure that the faster facilities — the higher-performing facilities — get more of the new allocation because we want it out the door,” Cuomo said. “We don’t want it sitting on the shelf. So those that can vaccinate faster will get more of the new allocation.”

Fox News’ Alexandria Hein contributed to this report.

US vows to aid WHO in coronavirus response: Fauci

A pledge from America’s top infectious disease expert that the United States would maintain ties with the World Health Organization (WHO) was met with gratitude by the head of the United Nations’ health agency.

Dr. Anthony Fauci, who is the new U.S. head of delegation to the WHO Executive Board under the Biden administration, made the remarks during a virtual meeting on Thursday. His comments came one year after the country confirmed its first COVID-19 case in Washington state and a day following the inauguration of President Joe Biden.

“I am honored to announce that the United States will remain a member of the World Health Organization,” Fauci said. “Yesterday, President Biden signed the letters retracting the previous administration’s announcement to withdraw from the organization.”

Fauci, speaking on behalf of the Biden administration, said the U.S. deeply values its relationship with the WHO, and will “look to strengthen [it] going forward.”

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, attends a Coronavirus Task Force news conference at the White House in Washington, D.C., U.S., on Friday, April 10, 2020. The United States’ pledge to maintain ties with the WHO, by Dr. Anthony Fauci following the inauguration of President Biden Wednesday, was met with deep gratitude by the head of the United Nations’ health agency.
(Kevin Dietsch/UPI/Bloomberg via Getty Images)

BIDEN TO REENGAGE WITH WHO AFTER TRUMP CUT TIES OVER COVID AND CHINA

Last July, the Trump administration submitted a notice of withdrawal from the WHO to the United Nations secretary-general, a senior administration official previously told Fox News, after Trump for weeks had blasted the WHO’s handling of the coronavirus pandemic and what he called its pro-China bias. The U.S. had been the top contributor to the agency, to the tune of approximately $450 million a year.

The official removal was set to go into effect July 2021 — a move now reversed by the Biden administration.

The Biden administration also plans to join COVAX, an initiative aimed at providing equitable access to COVID-19 vaccines in developing countries

“Given that a considerable amount of effort will be required by all of us moving forward, the United States stands ready to work in partnership and solidarity to support the international COVID-19 response, mitigate its impact on the world, strengthen our institutions, advance epidemic preparedness for the future and improve the health and wellbeing of all people throughout the world,” Fauci continued.

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The WHO Director-General Tedros Adhanom Ghebreyesus thanked Fauci for his support backing the agency over decades, and for Fauci’s leadership in the United States’ fight against the novel coronavirus.

“This is a good day for WHO and a good day for global health,” Tedros said. “The role of the United States, its global role is very very crucial,” the WHO chief continued, sending his thanks to President Biden and Vice President Kamala Harris.

“We look forward to continuing this partnership as I know all member states do…We have a lot of work to do and lessons to learn to end the pandemic and to meet the long list of global health challenges we face but the world will be able to meet them with you,” Tedros said.

Fox News’ Morgan Philips and Adam Shaw contributed to this report.

Moderna vaccine batch that caused 10 allergic reactions cleared for use

A batch of 330,000 doses of the Moderna COVID-19 vaccine that caused allergic reactions in at least 10 people has been cleared for continued use after health officials say they found “no scientific basis to continue the pause.”

California‘s Department of Public Health told providers to pause the distribution of the vaccine on Sunday evening, after some patients in San Diego reported after-effects of the vaccine including throat tightening and high blood pressure, indicative of a rare allergic reaction.

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“These findings should continue to give Californians confidence that vaccines are safe and effective, and that the systems put in place to ensure vaccine safety are rigorous and science-based,” California State Epidemiologist Dr. Erica Pan said.

Health officials said Wednesday that providers that halted the vaccinations could “immediately resume.”

Doses from the lot originally on hold were dispersed among Tulare, Mariposa, Merced, and Kings counties. In Merced, 150 vaccines have already been administered, while 200 people in Kings County had already administered shots before the pause went into effect.

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The release of the Moderna doses comes as California officials struggle to meet the challenge of vaccinating all those awaiting them, including millions of people 65 and older who recently were made eligible to receive the shot, after health care workers and people in nursing care homes.

At its peak, California receives about 400,000 to 500,000 doses a week but the rollout to administer the vaccine to patients has been slow and could take about four to five months for those 65 and older, Pan said during a state vaccine advisory committee meeting, according to the Sacramento Bee.

Large counties have been opening up more mass vaccination sites as they struggle with unprecedented demand. Officials are pinning hopes on President Biden’s promise to ramp up vaccination resources to get as many people vaccinated as soon as possible.

With the all-clear for Moderna’s vaccine, San Francisco will be able to use 8,000 doses it had put on hold and no longer expects to run out of vaccine on Thursday as previously feared, the San Francisco Chronicle reported. Health officials had received fewer than 2,000 additional doses this week for city hospitals and community clinics.

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The Associated Press contributed to this report.

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