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COVID-19 Home Collection Antibody Test Gets Emergency Use Authorization

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The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System (Symbiotica, Inc), the first antibody test authorized for use with home collected dried blood spot samples.

The Symbiotica COVID-19 Self-Collected Antibody Test System is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The EUA allows for fingerstick dried blood samples to be self-collected at home by an individual 18 years of age and older or collected by an adult from an individual 5 years of age and older. The collected samples are then sent to a Symbiotica, Inc laboratory for analysis. The test is available only by prescription.

“The authorization of the first prescription use, home collection antibody test will play an important role in helping health care professionals identify individuals who have developed an adaptive immune response from a recent or prior COVID-19 infection,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. 


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The Agency cautioned that the Symbiotica COVID-19 Self-Collected Antibody Test System should not be used to diagnose or exclude acute SARS-CoV-2 infection. It is unknown at this time if the presence of antibodies confers immunity and how long antibodies persist after an infection.

Reference

Coronavirus (COVID-19) update: FDA issues Emergency Use Authorization for the Symbiotica COVID-19 Self-Collected Antibody Test System. [press release]. Silver Spring, MD: US Food and Drug Administration; April 6, 2021. 

This article originally appeared on MPR

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Source: https://www.medicalbag.com/home/medicine/covid-19-home-collection-antibody-test-gets-emergency-use-authorization/

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FDA OKs Pfizer COVID-19 Vaccine For 12-15 Age Group

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A doctor prepares to administer a vaccine injection at New York-Presbyterian Lawrence Hospital in Bronxville, N.Y., in January. The Food and Drug Administration has approved emergency use authorization of the Pfizer/BioNTech vaccine for patients ages 12 to 15. Kevin Hagen/AP hide caption

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Kevin Hagen/AP

The Food and Drug Administration said Monday that children 12 to 15 years old are now eligible to receive a key COVID-19 vaccine as the agency expanded its emergency use authorization for the Pfizer/BioNTech vaccine.

Dr. Janet Woodcock, the acting FDA commissioner, said the expansion “brings us closer to returning to a sense of normalcy.”

“Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations,” Woodcock said.

Until now, the Pfizer vaccine had been authorized only for people age 16 and older. Pfizer asked the FDA to broaden its emergency use authorization for the vaccine after announcing in late March that clinical trials found “100% efficacy and robust antibody responses” in study participants who were 12 to 15.

The FDA first granted Pfizer’s request for an emergency use authorization for its COVID-19 vaccine in December. It got federal approval to include children as young as 12 in its vaccine trial in October.

All three makers of U.S.-authorized vaccines — Pfizer, Moderna and Johnson & Johnson — are studying the safety and effectiveness of their vaccines in children, including as young as 6 months.

Johnson & Johnson said last week that its vaccine “will initially be tested in a small number of adolescents, which will be expanded to a larger group in a step-wise approach, if initial data shows an acceptable safety profile.”

Those expanded trials started last month when J&J vaccine shots were given to teens from 16 to 17. If all goes well, the trial will include kids as young as 12, the company said.

Moderna said in mid-April that its vaccine study in adolescents is now fully enrolled, with around 3,000 people ages 12 to 17 slated to receive doses. A second phase of the study will follow, including children who are from 6 months to 11 years old.

Pfizer said it won’t be ready to ask the FDA for new emergency use authorization expansions for kids younger than 12 until September. One such request would cover children from 2 to 5 years old; a second would apply to ages 5 to 11. A third request, aimed at protecting infants and toddlers, isn’t expected until the fourth quarter of this year.

Pfizer and BioNTech said they have the capacity to manufacture up to 2.5 billion vaccine doses in 2021, and to produce at least 3 billion doses in 2022.

In another move that could boost COVID-19 vaccine availability, Pfizer recently asked the FDA to approve a change that would allow its vaccine to be stored at common refrigerator temperatures of 2 to 8 degrees Celsius (roughly 36 to 46 degrees Fahrenheit) for up to four weeks. The company said it submitted data about the vaccine’s stability at those temperatures on April 30.

In general, Pfizer’s vaccine must be stored at ultra-cold temperatures of around -70 degrees Celsius (-94 degrees Fahrenheit). The company loosened that requirement a bit in February, however, saying the shots, which use messenger RNA, could safely be kept at typical home freezer temperatures, -25 to -15 degrees Celsius (-13 to 5 degrees Fahrenheit), for up to two weeks.

The COVID-19 vaccine’s success has brought billions of dollars to Pfizer. In the first quarter of 2021 alone, the vaccine added $3.5 billion in global revenue, Pfizer Chairman and CEO Albert Bourla told investors in a conference call last week. Over the entire year, Pfizer could bring in around $26 billion based on the vaccine, Bourla said.

The company and BioNTech, its development and revenue-sharing partner, have shipped some 430 million doses to 91 countries and territories, Bourla said last week.

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Source: https://www.npr.org/sections/coronavirus-live-updates/2021/05/10/993591902/hold-fda-oks-pfizer-covid-19-vaccine-for-12-15-age-group

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China To Set Up ‘Line Of Separation’ On Mount Everest, Citing Nepal COVID-19 Outbreak

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China will set up a “line of separation” at Mount Everest’s summit, as Nepal struggles to control a COVID-19 outbreak. In this photograph, on May 2, 2021 mountaineers trek along the Khumbu glacier near Everest base camp in the Mount Everest region of Solukhumbu district, some 140 km northeast of Nepal’s capital Kathmandu. Prakash Mathema/AFP via Getty Images hide caption

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Prakash Mathema/AFP via Getty Images

China will set up a “line of separation” on one side of Mount Everest’s peak, saying the measure is needed to keep Nepal’s COVID-19 outbreak from crossing the border, according to state media.

The plan is part of China’s “zero contact strategy” to keep climbers from the Chinese and Nepalese sides of Everest from mixing if they reach the summit on the same day, said Nyima Tsering, head of the Tibetan Sports Bureau, according to the state-run Xinhua news outlet.

Everest straddles the border between Nepal and the Tibetan region of China — where the world’s highest mountain is known as Mount Qomolangma. The separation line will be erected by guides who are climbing alongside rope-fixing teams who are readying paths for the looming season.

Officials say the line will cordon off the northern side of the peak, starting from one of the highest Tibetan camps at 8,300 meters (about 27,230 feet), from which mountaineers leave to reach the summit.

China has barred foreigners from visiting Everest since last year, due to the pandemic. But for the 2021 mountaineering season, Chinese nationals have been granted 21 expedition permits for the north side of the mountain, Xinhua reports.

News of China’s plan comes after a coronavirus outbreak made headlines at Nepal’s Everest Base Camp, which is situated at 17,598 feet. Some climbers were evacuated to the capital, Kathmandu, for further tests and treatment for COVID-19. Last week, Nepalese officials reportedly confirmed around 17 cases, but anecdotal reports have put the number much higher, with more than 30 mountaineers said to be infected.

In addition to the separation line at the summit, the China Tibet Mountaineering Association has set up a checkpoint 300 meters from the base camp where climbers adjust to the high altitude’s low oxygen levels, Xinhua said.

Nepal’s health ministry has reported more than 403,000 COVID-19 cases, including more than 9,100 new infections on Monday. Nearly 3,900 Nepalese have died from the disease. There are currently more than 93,000 actives cases in Nepal, whose population tops 28 million people.

The rush of new COVID-19 cases has put Nepal’s public health system on the brink of disaster, according to Human Rights Watch.

“Large volumes of oxygen equipment and other medical supplies are urgently needed to avert a Covid-19 catastrophe in the country,” said Meenakshi Ganguly, HRW’s South Asia director.

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Source: https://www.npr.org/sections/coronavirus-live-updates/2021/05/10/995558121/china-to-set-up-line-of-separation-on-mount-everest-citing-nepal-covid-19-outbre

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COVID-19 Vaccines for 12-15-Year-Olds: Considerations for Vaccine Roll-Out

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With the Federal Drug Administration (FDA) on the cusp of authorizing a COVID-19 vaccine for those ages 12-15, the first group of children will become eligible in what will be an important next phase of the U.S. vaccination effort. While children are less likely to experience severe COVID-19 disease compared to adults, a small subset may develop serious illness leading to hospitalization and even death; the risk of severe disease is higher among Black and Hispanic adolescents compared to their White counterparts. In addition, since children can transmit to others, vaccinating children under age 16 will be important for achieving sufficient levels of population immunity to curb the pandemic. This is particularly the case given that the U.S. seems to have reached a COVID-19 vaccine “tipping point” among adults – that is, the point at which supply outstrips demand, making it that much harder to increase vaccine coverage. Vaccinating children may also further facilitate reopening of schools, which, in turn, will enhance the ability for parents to return to the workplace.

We examined the size and composition of adolescents ages 12 to 15 across the country using 2019 American Community Survey data to help inform vaccination efforts to reach this population. We find:

  • There are almost 17 million adolescents, ages 12-15, in the United States. Adolescents account for 5.3% of the U.S. population and 26.6% of the U.S. population under the age of 16. The share of adolescents varies by state. It ranges from a low of 3.4% in DC to 6.6% in Utah.
  • Nearly half of adolescents ages 12-15 are people of color, including one in four who are Hispanic, 13.4% who are Black, and 4.8% who are Asian (Figure 1). Certain states have more diverse adolescent populations. For example, over six in ten (61.4%) adolescents ages 12-15 in DC are Black, and over three in ten adolescents are Black in several other southern states, including Mississippi (41.7%), Louisiana (36.8%), Georgia (32.5%), Maryland (31.4%), and South Carolina (30.8%). States in the West and South include higher shares of Hispanic teens. For example, at least half of teens in New Mexico (62.2%), California (52.4%), and Texas (50.1%) are Hispanic.
  • More than a third (36.2%) of adolescents live in a family with incomes below 200% of the Federal Poverty Level (FPL), including 15.4% below poverty and 20.8% between 100-200% FPL (Figure 2). An additional 30.2% live between 200-400% FPL and 33.6% are above 400% FPL. This income distribution varies significantly by state. For example, the share of adolescents living in a low-income family (below 200% FPL) ranges from a low of 21.3% in Hawaii to a high of 49.2% in Mississippi. In 12 states, including Mississippi, the share of adolescents living below 200% FPL is greater than 40%; 10 of these states are in the South. In 5 states, more than 20% of adolescents live below the poverty level, 4 of which are in the South.

Implications

If the FDA authorizes and the Centers for Disease Control and Prevention (CDC) recommends COVID-19 vaccination for 12-15-year-olds, it will represent an important first step in reaching children more generally in the U.S. and increasing population immunity, but progress will hinge on outreach efforts and equitable and expeditious distribution strategies.

Reaching adolescents will likely take time, outreach, and effective communication to inform pediatricians, parents and adolescents about the vaccines as well as strategies to reduce barriers to access. Parents in particular will play a critical role in the success of these efforts, as our latest survey finds that 41% of parents of children ages 12-15 say they will definitely not get their children vaccinated or will only do so if required by school. These attitudes may shift once a vaccine is approved for teens and they begin receiving it, as it has for adults. Prioritizing equity and reducing access barriers that disproportionately affect people of color and those who are low income will be particularly important for reaching adolescents given the diversity of this population and that Black and Hispanic people have faced gaps in vaccinations so far.

The administration has indicated that, in addition to existing COVID-19 vaccine distribution channels, vaccines would be given directly to pediatricians to vaccinate their patients. Data from prior to the pandemic show that the large majority (96%) of children had a regular source of health care. However, analysis since the onset of the pandemic found declines in use of regular and preventive care among children, including declines in vaccination rates. This likely reflects parents delaying care due to concerns about potential exposure to coronavirus or due to cost if they experienced negative financial impacts from the pandemic. Because the vaccine is available for free regardless of insurance status, cost should not be a barrier to getting the vaccine. However, outreach to parents to explain that the vaccine is free will be important. Schools may also play an important role, including in serving as vaccine sites for children and their families.

Success in reaching this cohort will have important implications overall, for both future efforts to vaccinate those at even at younger ages and for the overall effort to vaccinate as many people in the U.S as possible.

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Source: https://www.kff.org/policy-watch/covid-19-vaccines-for-12-15-year-olds-considerations-for-vaccine-roll-out/

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Celebrities Push For Vaccine Equity At ‘Vax Live’ Benefit Concert

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Jennifer Lopez and her mother Guadalupe Rodríguez perform onstage during Global Citizen’s “Vax Live: The Concert To Reunite The World,” at SoFi Stadium in Inglewood, Calif. Kevin Winter/Getty Images for Global Citizen VAX LIVE hide caption

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Kevin Winter/Getty Images for Global Citizen VAX LIVE

A benefit concert leveraged major star power in a Saturday broadcast to address the latest obstacles to resolving the pandemic: vaccine inequity and vaccine hesitancy.

During Global Citizen’s “Vax Live: The Concert to Reunite the World,” politicians, celebrities and musicians pleaded with the public to get vaccinated and discouraged world leaders from stockpiling vaccine supplies, as the world faces stark gaps in access to COVID-19 vaccines.

The event — pre-taped at SoFi Stadium in Inglewood, Calif., before an in-person audience of 27,000 fully vaccinated health care and essential workers — painted a picture of what a post-pandemic world could look like if all were immunized against the coronavirus.

At the top of the show, in her first of two performances of the night, pop star Jennifer Lopez embraced her mother on stage during a rendition of “Sweet Caroline.”

“We’ve been away from our loved ones for too long, but we’re back,” Lopez said. “While it’s getting better for us, there are people all over the world — especially in Africa, India and in the Latin world — who still need our help and our vaccines.”

Hugh Evans, CEO of the anti-poverty organization Global Citizen that put on the event, said that mother-daughter moment was “the power of the vaccine at work.”

“They were both fully vaccinated and, therefore, you can hug your friends and family again,” he told NPR. “It’s those powerful things that we were working towards.”

Ahead of the broadcast, Global Citizen said its campaign had raised $302 million and secured over 26 million COVID-19 vaccine doses.

The money will go toward vaccine delivery, testing and personal protective equipment, as part of the COVAX initiative. The effort, led by the World Health Organization, Gavi and other partners, aims to evenly distribute vaccines and supplies around the world.

Evans said all of the vaccine doses pledged will be delivered to low-income countries by the end of this year per an agreement with Gavi, the Vaccine Alliance.

Prince Harry, who co-chaired the event with his wife Megan Markle, took the stage to thank frontline workers.

“We cannot rest or truly recover until there is fair distribution to every corner of the world,” said the Duke of Sussex. “The virus does not respect borders and access to the vaccine cannot be determined by geography.”

“We must look beyond ourselves with empathy and compassion for those we know, and those we don’t.”

While the U.S. and other wealthy countries have more doses than people who want them, the poorest ones have gotten less than 1% of the global supply.

India is facing a severe second wave and just 2% of its population is fully vaccinated. And two dozen countries, mostly in Africa, are using less than a third of their vaccines due to distrust over perceived risks and a lack of international support to help cover vaccine delivery.

The event also saw video messages from Pope Francis, President Joe Biden and first lady Jill Biden and Vice President Kamala Harris.

His Holiness called for “a spirit of justice that mobilizes us to ensure true universal access to vaccines” and “a spirit of communion that allows us to generate a different economic model that is inclusive, just and sustainable.”

The president and first lady encouraged people to get vaccinated: “We can’t let up now,” President Biden said. “The vaccines are safe, I promise you, they’re safe. They work.”

In a snappy narrated clip, Oprah Winfrey unpacked the science of vaccines and rollout logistics with the help of public health experts.

Meghan Markle spoke about how women worldwide, especially women of color, “have seen a generation of economic gain wiped out,” due to the pandemic, with millions facing extreme poverty.

Selena Gomez, who hosted the concert special, sent an urgent plea to viewers.

“If you’re on the fence about getting vaccinated, if you don’t think you need it to protect yourself, I’m not going to lecture you. I’m going to beg you. Please get vaccinated — for your family, your neighbors, and every single person you come in contact with,” the singer said.

Also appearing on stage were Chrissy Teigen, David Letterman, Ben Affleck, Jimmy Kimmel, Sean Penn and Olivia Munn.

Musical acts included the Foo Fighters — with a surprise guest AC/DC’s Brian Johnson — along with Eddie Vedder, J Balvin and H.E.R.

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Source: https://www.npr.org/2021/05/08/995112377/celebrities-push-for-vaccine-equity-at-vax-live-benefit-concert

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