Spain to Test Mixing COVID Vaccines After Restricting AZ Shot

MADRID (Reuters) – Spain will study the effects of mixing different coronavirus vaccines, government researchers said on Monday, responding to shifting guidelines on the safety of the AstraZeneca’s shot.

Along with several other European countries, Spain restricted vaccines produced by the Anglo-Swedish drug maker to people over 60 after regulators linked it to a rare form of brain blood clots, mostly in younger women.

“After decisions by various European public health authorities to suspend use of the AstraZeneca vaccine in under 60 year olds, we are setting out to urgently find scientific evidence to support decision making around possible alternatives,” Raquel Yotti, director of the Carlos III Health Institute, told a news conference.

The trial will draw on a sample of 600 people of all ages from across Spain, said Jesus Frias Iniesta, clinical research coordinator at Carlos III.

“The study’s objective is…to determine within 28 days whether a second dose of the Pfizer vaccine can be given to patients who have received the AstraZeneca vaccine,” he said.

A UK study on mixing vaccines was expanded last week to include shots made by Moderna and Novavax, while France and Germany are considering giving an alternative to under 60s who received a first dose of AstraZeneca.

Separately, Spain’s El Mundo newspaper reported the health ministry was considering delaying second doses for under 80 year olds to maximise the number of people who received at least one injection.

Patients would receive a second shot of vaccines produced by Pfizer and Moderna eight weeks after the first, El Mundo said. The European Medicines agency recommends a 28-day gap between Moderna shots and 21 days between Pfizer.

The proposal would signal a sharp departure from the current national strategy, which favours giving vulnerable age groups a full course of two shots as quickly as possible.

The Health Ministry was not immediately available for comment.

Several real-world studies have shown a first dose of the Pfizer-BioNTech vaccine provides a high level of protection.

Despite delays to the deployment of the one-shot Johnson & Johnson vaccine and supply disruptions at AstraZeneca, Spain still expects to have half its 47-million population fully inoculated by late July.

Data released on Friday showed 7% of the population had received a full course, while 19% had received at least one dose.

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COVID Vaccine Makers Have More Than Boosters in the Works

 

Vaccine boosters are part of the plan to protect against COVID-19 and emerging variants, but so are entirely new approaches to vaccination, including delivery routes that eliminate the need for injections, and easier storage to help ease vaccine supply shortages.

Next-generation COVID vaccines will have many different targets. Read what developers are investigating next.

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J&J Pause Magnifies Worry About COVID-19 Vaccine Hesitancy

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s  Coronavirus Resource Center.

The news today that states are being asked to pause administration of the Johnson & Johnson COVID-19 vaccine is bringing new fears of vaccine hesitancy that could push back the nation’s goal for herd immunity.

The Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) are reviewing data involving six reported US cases of a rare and severe kind of blood clot — cerebral venous sinus thrombosis — in people who got the J&J vaccine. All six cases were in women 18 to 48 years old, and symptoms occurred 6 to 13 days after their vaccination.

More than 6.8 million doses of the Johnson & Johnson vaccine have been administered in the United States.

William Schaffner, MD, an infectious disease expert at Vanderbilt University School of Medicine in Nashville, Tennessee, told Medscape Medical News that several messages are important to emphasize given the potential for more hesitancy.

“One is that our safety surveillance system is very comprehensive,” he said. “It is very sensitive and it works, and we’re being transparent about it.”

Another is that the number of cases being reviewed is literally 1 in a million.

“We’re talking about needles in haystacks here,” Schaffner said. “These blood-clotting events are an even smaller risk than the blood-clotting events associated with birth control pills.”

He said he has heard questions about why the potential complications weren’t  caught earlier and criticism that the complications are proof the trial was rushed.

“That’s not the case,” Schaffner explained. “When you have a trial of only 15,000 people — though that’s a huge trial — if you have a risk that is 1 in a million, it’s very unlikely to show up in the trial. You have to monitor what happens when you start using drugs or vaccines in the real world and you give it to literally millions of people.”

The CDC will convene its Advisory Committee on Immunization Practices (ACIP) on Wednesday to review the cases, and the FDA will also review them.

Schaffner said he hopes and expects after a review that Johnson & Johnson vaccine administration can resume, perhaps with restrictions, as some European countries have placed on the AstraZeneca vaccine.

Johnson & Johnson vaccine is one of three vaccines approved for emergency use in the United States. The vaccines from Moderna and Pfizer-BioNTech use messenger RNA instead of adenovirus and no serious side effects have been reported in the tens of millions in the US who have received those shots.

Johnson said in a statement, “The health authorities advise that people who have received our COVID-19 vaccine and develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their healthcare provider.”

Tim Schacker, MD, vice dean for research and an infectious disease physician with the University of Minnesota Medical School in Minneapolis, told Medscape Medical News that the Johnson & Johnson news today is another barrier to achieving herd immunity, a goal for which “we already had a long way to go.”

A national survey finds that to be the case as well.

Last week, Surgo Ventures released the results of its second survey on enthusiasm for receiving a COVID-19 vaccine and found that acceptance is generally high, with 59% of the population now saying they have already been vaccinated or want to be as soon as they can get one.

That was up from 40% in Surgo’s first survey, conducted in early January.

However, the survey authors said in a press release that respondents’ answers to when they would get a shot — “as soon as it’s available,” “in three months,” “in a year,” etc. — combined with current vaccination rates suggest that doses could start to outpace demand by the end of this month, which is earlier than expected. And that’s long before the nation reaches the 70%-90% threshold needed for herd immunity.

Benefit Outweighs Risk

Schacker applauded the decision to halt administration of the J&J vaccine.

“I think the FDA and the CDC did exactly the right thing by pausing for a day or two to look at the data and make an assessment,” he said.

He said it’s also important to remember that all medications come with risks.

“With people on Lipitor (atorvastatin), the risk of muscle necrosis, known as rhabdomyolysis — which people can die from — is 1 in 100,000, 10 times greater than the blood clot risk talked about with J&J. I don’t mean to trivialize it,” Schacker said. “I’m just saying we’re all on medications that have risks.”

He said he also hopes the reviews in the next couple of days will clear the Johnson & Johnson vaccine for use because it has advantages over the others: it doesn’t have the same requirements for refrigeration; it’s one dose;  and it’s a key to vaccinating those in hard-to-reach populations.

“The benefits of any of the COVID vaccines, I think, outweigh the risks,” he said.

Schaffner and Schacker declared no relevant financial relationships.

Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick

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EU Seeks New Contract With Pfizer/BioNTech for Up to 1.8 Bln Vaccines From 2022: EU Source

BRUSSELS (Reuters) – The European Commission is seeking EU governments’ approval to launch talks with Pfizer and BioNTech for the purchase of up to 1.8 billion doses of their COVID-19 vaccines to be delivered in 2022 and 2023, an EU official told Reuters.

Earlier on Friday, German daily Die Welt reported that the Commission was shortly to sign contracts to buy up to 1.8 billion doses, but did not say with which company.

The EU official, who asked not to be named because the matter is confidential, said the EU executive had already decided to approach Pfizer-BioNTech and that EU governments backed the plan, though there was not yet a definitive approval.

A Commission spokesman confirmed plans to buy the additional doses, of which half would be optional.

He also confirmed that the EU executive had already identified one supplier, a manufacturer of mRNA vaccines, but declined to comment on which company would be approached to negotiate the contract.

“If provided the opportunity Pfizer and BioNTech are prepared to supply Europe with hundreds of millions of doses of COVID vaccines in 2022 and 2023 produced in our manufacturing facilities in Europe,” a Pfizer spokesman said.

The two companies have the capacity to produce more than 3 billion doses of vaccine in 2022, he added.

Pfizer-BioNTech and Moderna are already supplying the EU with mRNA vaccines and German biotech firm CureVac is seeking EU approval for its mRNA shot.

The vaccines would be delivered under monthly timetables and with clauses obliging the supplier to deliver, the EU official said.

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South Korea Pays Price for Reliance on COVAX, Scrambles for Vaccines

SEOUL (Reuters) – South Korean authorities are facing a backlash for relying on global vaccine-sharing scheme COVAX for a bulk of its COVID-19 shots as shipment delays threaten to slow the country’s inoculation programme.

Once praised by the World Health Organization for its decision to procure vaccines through the global scheme, South Korea is now facing criticism at home as the government scrambles to meet the supply shortfall.

South Korea, Indonesia, the Philippines and Vietnam are among countries to be hit by shipment delays to vaccines they have been promised following export curbs by manufacturer India.

In February, South Korea slashed its first quarter vaccination target from 1.3 million people to just 750,000 due to adjustments in the supply timetable of the 2.6 million doses of AstraZeneca’s coronavirus vaccine from COVAX.

The latest COVAX shipment disruption announced earlier this week – that it would only receive 432,000 doses instead of 690,000 and delivery would be delayed to around the third week of April – is the second time that South Korea’s vaccine rollout has been hit by delayed supply from the scheme.

“The government should no longer cause public anxiety with the vaccines,” Lee Yong-ho, an independent lawmaker who sits on parliament’s health and welfare committee, said.

“It should either impose export curbs on the locally produced vaccines until the supply uncertainties are resolved, or come up with a special vaccine procurement strategy and bring the originally contracted quantity as planned.”

South Korean health authorities said they were not considering restricting exports of locally produced vaccines, but instead, holding talks with vaccine makers and distributors to advance delivery timelines.

The efforts appear to be bearing fruit with the government announcing on Thursday that delivery of the 432,000 doses of the AstraZeneca vaccines from COVAX would be brought forward to Saturday from the third week of April.

“(We) have accelerated administrative process and were able to bring forward the schedule from what COVAX had initially informed us,” the Korea Disease Control and Prevention Agency said.

The fluctuating shipment schedules have raised concerns about the country’s aim to immunise 12 million people by June, reaching herd immunity by November, but government officials have assured the goal is achievable.

“This is a very achievable target as we have factored supply schedule and our inoculation capability into the calculation,” Prime Minister Chung Sye-kyun told a news conference on Thursday.

Assuming no further delays, South Korea is scheduled to receive 13.7 million doses in the second quarter — 6 million from Pfizer Inc, 7 million from AstraZeneca and 729,000 from COVAX.

Oh Se-hoon, opposition candidate for Seoul’s mayoral by-election, attacked the government this week for its slow vaccine rollout, which he said was the world’s 105th to kick off.

The slow rollout was partly due to the country’s early strategy to focus more on containing the virus through aggressive testing and contact tracing than striking bilateral vaccine deals.

While most wealthy nations had shunned joint purchases through COVAX, raising concerns over vaccine inequity, South Korea committed to procure vaccines from the scheme which earned praise from the WHO.

“The Republic of Korea despite being a high-income country that could easily afford to buy vaccines through bilateral deals has waited its turn for vaccines through COVAX,” WHO Director-General Tedros Adhanom Ghebreyesus said on March 22.

Mike Ryan, WHO’s top emergency expert, also lauded South Korea’s overall efforts to contain the COVID-19 disease.

He said the country not only developed a very successful surveillance and testing regime but exported those tests around the world, kept the disease under control in a very significant way, and have numbers of disease that are “the envy of the world.”

South Korea reported 551 new cases on Wednesday, bringing the country’s total infections to 103,639, with 1,735 deaths.

Despite international plaudits, some like lawmaker Lee said the slow rollout raises doubts about the government’s plan to reach herd immunity this year.

“With just 1.5% of the total 52 million population vaccinated, it is questionable with current supply when we will ever reach the herd immunity.”

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Feds Still Expecting Updated Data on AstraZeneca COVID Vaccine

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

March 24, 2021 — White House officials said at a briefing Wednesday they are still anticipating updated vaccine data from AstraZeneca, after federal officials called Tuesday’s release of interim phase 3 data from the company “outdated information.”

“Right now, AstraZeneca is getting back with the Data and Safety Monitoring Board and will likely come out with an updated statement,” said Anthony Fauci, MD, a top COVID-19 official and chief of the National Institute of Allergy and Infectious Diseases, the agency that complained to the pharmaceutical company that their current information was “incomplete.”

Andy Slavitt, senior White House adviser for COVID-19 response, added: “Our takeaway is the importance of transparency and trust…. I would urge us not to focus on the process of the last couple days, but instead to focus on what really matters, which is what happens when these applications for these candidates are submitted to the FDA.”

AstraZeneca has said it plans to submit data to the US Food and Drug Administration next month in pursuit of an emergency use authorization for its vaccine.

Officials at the briefing also announced that President Joe Biden will authorize the government to spend $81 billion to help schools get back to in-person learning — a step toward his stated goal of reopening schools within the first 100 days of his presidency.

“Today, at the Department of Education’s National Safe School Reopening Summit, President Biden will announce $81 billion in American Rescue Plan funds will be made available to all 50 states, DC, and Puerto Rico to support their efforts to safely return to in-person instruction as expeditiously as possible this spring and meet the needs of all students,” said Slavitt.

The recent coronavirus relief bill that Biden signed into law earmarks $122 billion for K-12 schools. The $81 billion announced Wednesday will be available right away.

Slavitt also reported that 70% of Americans ages 65 and older have now received at least one vaccine dose — up from 8% at the beginning of February.

“In the 62 days since taking office, we’ve more than tripled vaccine output from 8.6 million doses to 27 million doses per week,” he said. “We intend to keep up this progress until all Americans are vaccinated.”

Fauci also outlined data published Tuesday in The New England Journal of Medicine highlighting how well COVID-19 vaccines work in the real world, which mirrors findings from clinical trials. One study, published Tuesday, found that just four out of 8121 fully vaccinated employees at the University of Texas Southwestern Medical Center in Dallas were infected with the virus.

Another study found that seven out of 14,990 workers at UC San Diego Health and the David Geffen School of Medicine at the University of California, Los Angeles, produced positive COVID-19 tests after receiving a second dose of vaccine from either Pfizer or Moderna.

“Every day, we get closer and closer to that extraordinary degree of effectiveness, which we’re seeing at the community level,” Fauci said. “And at the end of the day, that’s what it is that’s going to end this pandemic in this country.”

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Don’t Stop Osteoporosis Meds for COVID-19 Vaccines, Say Experts

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

COVID-19 vaccines are safe and effective for patients taking osteoporosis medications, according to joint guidance from six endocrine and osteoporosis societies and foundations.

They noted, though, that some timing modifications with certain medications should be considered to help distinguish between adverse events from the medication versus the vaccine.

The American Society for Bone and Mineral Research “is an international organization, so we brought together our sister societies that have a vested interested in bone health. Vaccination is happening worldwide, and we wanted to present a united front and united recommendations about how to handle osteoporosis medications appropriately during vaccination,” said Suzanne Jan De Beur, MD, who is president of ASBMR and an associate professor of medicine at Johns Hopkins University, Baltimore.

There has been quite a lot of concern from the community about vaccine and medications, from both physicians and patients wondering whether treatments and vaccines should occur in a certain order, and whether there should be a time gap between the two, said Jan De Beur. “There was a dearth of information about the best practices for osteoporosis treatment management during vaccination, and we didn’t want people missing their opportunity for a vaccine, and we also didn’t want them unnecessarily delaying their osteoporosis treatment.”

There is no evidence that osteoporosis therapies affect the risk or severity of COVID-19 disease, nor do they appear to change the disease course. Osteoporosis itself does not appear associated with increased risk of infection or severe outcomes, so patients with osteoporosis do not need to be prioritized for vaccination based on that condition alone.

There is no evidence that osteoporosis therapies affect the safety or efficacy of vaccination, but given that vaccine availability is currently inconsistent, patients may need to make temporary changes to their osteoporosis regimens to ensure they can receive vaccine when it is available, such as ensuring a delay between medication and vaccination injections.

A key reason for a delay between injectable or infusion medications and a vaccine is to distinguish between adverse events that could occur, so that an adverse reaction to vaccine isn’t mistaken for an adverse reaction to a drug. Nevertheless, the real world is messy. Jan De Beur noted a recent patient who arrived at her clinic for an injectable treatment who had just received a COVID-19 vaccination that morning. “We decided to put the injection in the other arm, rather than reschedule the person and put them through the risk of coming back. We could distinguish between injection-site reactions, at least,” she said.

No changes should be made to general bone health therapies, such as calcium and vitamin D supplementation, weight-bearing exercises, and maintenance of a balanced diet.

The guidance includes some recommendations for specific osteoporosis medications.

  • Oral bisphosphonates: Alendronate, risedronate, and ibandronate should be continued.

  • Intravenous bisphosphonates: a 7-day interval (4-day minimum) is recommended between intravenous bisphosphonate (zoledronic acid and ibandronate) infusion and COVID-19 vaccination in order to distinguish potential autoimmune or inflammatory reactions that could be attributable to either intravenous bisphosphonate or the vaccine.

  • Denosumab: There should be a 4- to 7-day delay between denosumab infusion and COVID-19 vaccination to account for injection-site reactions. Another option is to have denosumab injected into the contralateral arm or another site like the abdomen or upper thigh, if spacing the injections is not possible. In any case, denosumab injections should be performed within 7 months of the previous dose.

  • Teriparatide and abaloparatide should be continued.

  • Romosozumab: There should be a 4- to 7-day delay between a romosozumab injection and COVID-19 vaccine, or romosozumab can be injected in the abdomen (with the exception of a 2-inch area around the naval) or thigh if spacing is not possible.

  • Raloxifene should be continued in patients receiving COVID-19 vaccination.

Guidance signatories include ASBMR, the American Association of Clinical Endocrinology, the Endocrine Society, the European Calcified Tissue Society, the National Osteoporosis Foundation, and the International Osteoporosis Foundation.

Jan De Beur has no relevant financial disclosures.

This article originally appeared on MDedge.com, part of the Medscape Professional Network.

 

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Rich, Developing Nations Wrangle Over COVID Vaccine Patents

GENEVA (Reuters) – Richer members of the World Trade Organization (WTO) blocked a push by over 80 developing countries on Wednesday to waive patent rights in an effort to boost production of COVID-19 vaccines for poor nations.

South Africa and India renewed their bid to waive rules of the WTO’s Trade-Related Aspects of Intellectual Property (TRIPS) agreement, a move that could allow generic or other manufacturers to make more vaccines.

South Africa argued the current TRIPS system does not work, pointing to the failure to secure life-saving medicines during the HIV/AIDS pandemic that had cost at least 11 million African lives.

Medecins Sans Frontieres in October put together a letter signed by over 375 civil society organisations supporting the waiver.

The South Africa and India proposal was backed by dozens of largely developing countries at the WTO, but opposed by Western countries, including Britain, Switzerland, EU nations and the United States, which have large domestic pharmaceutical industries.

India is a major manufacturer of generics, although many of the largest generic companies are based in Western and developed countries, including Viatris, Sandoz and Teva.

Western nations argue protecting intellectual property rights encouraged research and innovation and that suspending those rights would not result in a sudden surge of vaccine supply.

In its eighth discussion on the topic since it was first raised in October, the WTO’s TRIPS Council spent three hours debating, but failed to agree. Proposals need backing by a consensus of the WTO’s 164 members to pass.

They did at least agree to discuss the matter twice again in April before the next scheduled TRIPS Council meeting on June 8-9.

Ngozi Okonjo-Iweala, who became WTO director-general on March 1, called the intensifying TRIPS discussions “vitally important,” but said governments and businesses needed to act now to increase production, especially in emerging markets.

She said in a speech on Tuesday that manufacturers should come together with bodies such as the World Health Organization and vaccines alliance GAVI, whose board she used to chair, and business associations to look into options.

“We must make sure that in the end we deliver so that the millions of people who are waiting for us with bated breath know that we are working on concrete solutions,” the former Nigerian finance and foreign minister said.

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Guilt, Envy, Distrust: Vaccine Rollout Breeds Mixed Emotions

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

This image shows part of an Instagram post by Jeff Klein holding his COVID-19 vaccination card. The 44-year-old musician notes he was given a shot as a volunteer at a mass vaccination hub.

NEW YORK (AP) — Before posting a selfie with her COVID-19 vaccination card on Twitter, Aditi Juneja debated whether to include an explanation for why she was eligible for a shot.

“The first draft of the tweet had an explanation,” says Juneja, a 30-year-old lawyer in New York City.

After some thought, she decided to leave out out that her body mass index is considered obese, putting her at higher risk of serious illness if infected. A friend who disclosed the same reason on social media was greeted with hateful comments, and Juneja wanted to avoid that.

The rollout of COVID-19 vaccines in the U.S. is offering hope that the pandemic that has upended life around the world will finally draw to an end. But as distribution widens in the U.S., varying eligibility rules and unequal access to the coveted doses are also breeding guilt, envy and judgment among those who’ve had their doses — particularly the seemingly young and healthy — and the millions still anxiously awaiting their turn.

Adding to the second-guessing about who should be getting shots is the scattershot feel of the rollout, and the sense that some might be gaming the system. Faced with a patchwork of confusing scheduling systems, many who aren’t as technically savvy or socially connected have been left waiting even as new swaths of people become eligible.

The envy and moral judgments about whether others deserve to be prioritized are understandable and could reflect anxieties about being able to get vaccines for ourselves or our loved ones, says Nancy Berlinger, a bioethicist with the Hastings Center.

“There’s the fear of missing out, or fear of missing out on behalf of your parents,” she says.

Stereotypes about what illness looks are also feeding into doubts about people’s eligibility, even though the reason a person got a shot won’t always be obvious. In other cases, Berlinger says judgments could reflect entrenched biases about smoking and obesity, compared with conditions that society might deem more “virtuous,” such as cancer.

Yet even though a mass vaccination campaign is bound to have imperfections, Berlinger noted the goal is to prioritize people based on medical evidence on who’s most at risk if infected.

Nevertheless, the uneven rollout and varying rules across the country have some questioning decisions by local officials.

In New Jersey, 58-year-old software developer Mike Lyncheski was surprised when he learned in January that smokers of any age were eligible, since he knew older people at the time who were still waiting for shots.

“It didn’t seem like there was medical rationale for it,” says Lyncheski, who isn’t yet eligible for the vaccines. He also noted there’s no way to confirm that people are smokers, leaving the door open for cheating.

The suspicions are being fueled by reports of line jumpers or those stretching the definitions for eligibility. In New York, a Soul Cycle instructor got vaccinated after teachers became eligible in January, the Daily Beast reported, and later apologized for her “terrible error” in judgment. In Florida, two women wore bonnets and glasses to disguise themselves as elderly in hopes of scoring shots. Hospital board members, trustees and donors have also gotten shots early on, raising complaints about unfair access.

It’s why some feel obligated to explain why they were able to get the vaccine. In an Instagram post, Jeff Klein held up his vaccination card and noted he was given a shot as a volunteer at a mass vaccination hub.

“I definitely mentioned it on purpose, because I didn’t want people to get the wrong idea,” says Klein, a 44-year-old musician in Austin, Texas.

As she waited for a shot in Jacksonville, Florida, 33-year-old Amanda Billy said it could be frustrating seeing people her age in other states posting about getting vaccinated. She understood that state rollouts vary, but felt anxious because she has a medical condition that makes COVID-19 “very real and scary.”

“I’m just happy for them that they got it. But also, I want it,” she said in an interview before getting her first shot.

Others are finding they are opening themselves up to criticism when sharing news that they got a shot. Public figures in particular might become targets of second-guessing by strangers.

In New York, local TV news co-host Jamie Stelter posted a photo of herself after getting the first shot earlier this month. Many replies were positive, but others noted that she didn’t look old enough or that she must “have connections.”

Afterward, Stelter’s co-host Pat Kiernan weighed in and tweeted that the “you don’t look that sick to me” commentary she received was “evidence of the hell that COVID has placed us in.”

For Juneja, the decision to get a shot after becoming eligible wasn’t easy, given the struggles she knew others were having securing appointments because of technology, language or other barriers. But she realized it wouldn’t help for her to refrain from getting vaccinated.

“It’s not like with other types of things where I could give my spot to someone else who I think is more in need,” she says. “We are sort of all in this situation where we can only really decide for ourselves.”

Candice Choi, a reporter on The Associated Press’ Health & Science team, has been covering the pandemic and vaccine rollout in the United States.

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New Adjuvant Boosts SARS-CoV-2 Protection in Mice

NEW YORK (Reuters Health) – A novel adjuvant that delivered a SARS-CoV-2 vaccine directly to the lymph nodes in mice might be an effective option for humans, researchers suggest.

“Our new vaccine adjuvant, Amphiphile (AMP)-CpG is exciting because it can ‘hitchhike’ on albumin from the site of injection and ride into lymph nodes where new T cell and B cell responses begin,” Dr. Christopher Haqq of Elicio Therapeutics in Cambridge, Massachusetts, which funded the study and employs all the authors. “Having a way to target new variants through T cells could make a huge difference in the pandemic.”

“Our (study) showed that AMP-CpG with the SARS-CoV-2 receptor binding domain generated 25-fold higher numbers of T cells compared to standard vaccine adjuvants,” he noted. “We found T cells not only in the peripheral blood, but also in lung tissue, and even in the respiratory fluid that would be the first site to be infected if a patient developed COVID-19 pneumonia.”

As reported in Science Advances, Dr. Haqq and colleagues evaluated an AMP-CpG adjuvant made of diacyl lipid-modified cytosine-guanine (CpG) admixed with the SARS-CoV-2 Spike-2 receptor binding domain protein as a candidate vaccine (ELI-005) in mice.

As Dr. Haqq indicated, the adjuvant efficiently delivered CpG to lymph nodes, where innate and adaptive immune responses are generated. Mice immunized with a vaccine containing the new adjuvant had an antigen-specific T-cell response that was more than 25-fold greater than that of mice given the same vaccine with alum; importantly, as Dr. Haqq noted, the T cells also traveled to the lungs.

In another experiment, the team tested a vaccine containing AMP-CpG admixed with the SARS-CoV-2 spike receptor (Spike RBD) at varying doses (1, 5, and 10 micrograms). Even the 1-microgram antigen admixed with AMP-CpG yielded a significantly higher T cell response than CpG-only or alum mixed with a 10-microgram antigen dose.

Further, the antibody responses favored TH1 isotypes (IgG2c and IgG3), and neutralized SARS-CoV-2 with titers 265-fold higher than antibodies naturally present in convalescent patient COVID-19 responses; T cell and antibody responses were maintained even with the 10-fold dose reduction in Spike antigen.

“We also tested a group of aged mice that have impaired immune responses to model elderly humans like those…in nursing home populations,” Dr. Haqq said. “Despite the decline in the immune system that occurs with aging, we saw potent responses similar to young mice.”

The authors conclude that the adjuvant “merit(s) clinical translation to SARS-CoV-2 and other protein subunit vaccines.”

Dr. Haqq added, “AMP-CpG is not only part of our SARS-CoV-2 vaccine candidate, it is also the key adjuvant in our company’s lead oncology product candidate, ELI-002, which targets mutant forms of KRAS, found in many solid tumors. We’ve just received FDA clearance to begin our cancer trial, so we’ll soon have patient data.”

Infectious diseases specialist Dr. Carl Fichtenbaum, Associate Chairman of Medicine for Translational Research and Professor of Clinical Medicine at the University of Cincinnati College of Medicine, commented by email to Reuters Health. “It sounds promising, but very early days and lots more to learn before this becomes the optimal solution.”

“We need to understand where the optimal site of protection is in the body,” he said. “Is it at the surface where the infection first starts? Is it in the immune system network, like lymph nodes? Do we need a combination of both?”

“It’s interesting,” he said, “but we need a lot more research to know if this produces higher levels of protection for infections like SARS-CoV-2, and we will need human studies to see if what is proven in animals studies works in humans.”

The study was funded by Elicio Therapeutics and all all authors are employees of the company.

SOURCE: https://bit.ly/30eTxXu Science Advances, online February 5, 2021.

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