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.
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.
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
COVID-19 Was ‘A Preventable Disaster,’ WHO-Ordered Report Says
The COVID-19 pandemic exposed dangerous failings on the national and international scale, according to an independent review ordered by the World Health Organization. The review found a range of problems, from a slow initial reaction to the coronavirus to “weak links at every point in the chain of preparedness and response.”
The coronavirus found a world vulnerable to the worst effects of a pandemic despite warnings from experts and a string of recent global health threats, from SARS and Ebola to Zika, the Independent Panel for Pandemic Preparedness and Response said.
COVID-19 was “a preventable disaster,” the panel said as it released its report.
Circumstances have not improved in the past year, the panel said, noting that “the system as it stands now is clearly unfit to prevent another novel and highly infectious pathogen, which could emerge at any time, from developing into a pandemic.”
Problems with the global response to the pandemic began early. The WHO waited too long to declare a public health emergency of international concern, the panel said, after the reporting of an initial cluster of cases in December 2019.
National governments also wasted precious time, the report said, calling February 2020 “a lost month” when countries could have been acting to contain the coronavirus and prevent the pandemic’s worst effects.
“Global political leadership was absent,” the independent experts said.
“The combination of poor strategic choices, unwillingness to tackle inequalities, and an uncoordinated system created a toxic cocktail which allowed the pandemic to turn into a catastrophic human crisis,” according to the panel.
COVID-19 has now claimed more than 3.3 million lives, obliterated trillions of dollars in production and worsened inequalities around the world.
Identifying a systemic issue, the report said the WHO lacks the power to investigate and act swiftly when confronted with potential outbreaks.
“Technical expert missions can be dispatched to individual countries only with their permission, and a system of preauthorization of missions has not been established,” the report said. “Often lengthy negotiations with governments for access by missions are required after an outbreak has been notified.”
The panel was convened in September, months after members of the World Health Assembly voted to require the WHO to order an independent review of the global response to the health crisis. The 13-member body is co-chaired by former New Zealand Prime Minister Helen Clark and former Liberian President Ellen Johnson Sirleaf.
“Our message is simple and clear: The current system failed to protect us from the COVID-19 pandemic,” Sirleaf said.
“The shelves of storage rooms in the U.N. and national capitals are full of reports and reviews of previous health crises,” she added. “Had their warnings been heeded, we would have avoided the catastrophe we are in today. This time must be different.”
Calling COVID-19 “a terrible wake-up call,” the panel issued a string of recommendations, including a request for high-income countries to provide at least 1 billion vaccine doses to middle-income countries and more than 2 billion doses by the middle of 2022.
The panel is also urging the formation of a Global Health Threats Council and a system for outbreak surveillance that is based on full transparency. And individual countries must also do more now, the report said, to prepare for the next crisis.
Federal Panel Recommends Coronavirus Vaccines For Adolescents Aged 12-15
An independent federal advisory committee on Wednesday recommended that the Pfizer-BioNTech coronavirus vaccine be administered to adolescents aged 12 to 15 — a move expected to be quickly approved by the Centers for Disease Control and Prevention.
Wednesday’s decision could open up a new front in the fight against COVID-19 after the Food and Drug Administration’s extension of its emergency use authorization for the Pfizer vaccine to cover adolescents. The vote was 14 in favor with one recusal.
Previously, coronavirus vaccines in the U.S. had only been approved for people age 16 and older. Pfizer is the first vaccine manufacturer to gain emergency use authorization for younger Americans after it demonstrated in a March clinical trial that its vaccine was 100% effective in preventing COVID-19 in study participants who were aged 12 to 15.
During a meeting lasting nearly four hours, the committee heard details of studies showing the vaccine prevented COVID-19 in more than 1,000 adolescents in the age range, while 16 cases occurred in those who got a placebo. There were no serious side effects reported.
Public health officials, including those from the CDC and the independent advisors on the committee, said the vaccine will further help control the pandemic in the U.S. and in other countries that typically follow the U.S. lead. Data presented by the CDC showed that about 20% of COVID-19 cases in the U.S. have been in children and adolescents 17 years of age and younger.
The American Academy of Pediatrics endorsed the move in a statement read during the meeting.
“This is truly an exciting development that allows us to protect a large population of children and help them regain their lives after a really rough year,” said AAP President Lee Savio Beers. “As a pediatrician and a parent, I have looked forward to getting my own children and patients vaccinated, and I am thrilled that those ages 12 and older can now be protected. The data continue to show that this vaccine is safe and effective. I urge all parents to call their pediatrician to learn more about how to get their children and teens vaccinated.”
Comments from the public during an open session included questions of whether the relatively low risk of serious COVID-19 complications in children justifies the use of the vaccine in this age group before more studies are performed. The study included more than 2,000 adolescents, but was criticized by some public commenters for not being of sufficient size. Commenters also expressed concern that the studies were not sufficient to demonstrate whether there are any long-term effects associated with this or other COVID-19 vaccines.
CDC and company officials stressed study findings that show that the vaccine is extremely safe in this age group, paralleling what has been seen in adults for several months now. More than 150 million people have received at least one dose of one of the vaccines with a very low rate of serious side effects.
The authorization and endorsement come in time for many adolescents to get vaccinated before participating in summer activities such as camping and group sports. Efforts to get as many adolescents vaccinated as possible before school restarts in August and September are already underway.
In the pediatric studies, the CDC and FDA evaluated the same two-dose regimen separated by three weeks that is used for people aged 16 and up.
While children and adolescents generally have milder symptoms if they contract COVID-19 compared to adults, they can nonetheless pass the disease on to others. That has parents worried about the prospect of schools fully re-opening in the fall.
“I think we should be in full school, full in-person school, in the fall,” CDC Director Dr. Rochelle Walensky said at a CNBC health summit on Tuesday.
Despite the Biden administration’s push to get enough Americans inoculated against COVID-19 to establish “herd immunity,” the pace of vaccinations in the U.S. has slowed in recent weeks, with many adults opting not to get the shots.
CDC data show that just over a third of Americans are fully vaccinated, with 46% having received at least one dose. While surveys have showed that only about 46% to 60% of parents said they planned to have their adolescent children immunized, opening up vaccinations for millions of adolescents would likely get the U.S. closer to the goal of herd immunity.
In March, both Pfizer and Moderna launched pediatric trials of their vaccines in children as young as 6 months old. Results are expected in the early fall. Neither company has applied to the FDA for emergency use authorization in children younger than 12.
Johnson & Johnson resumed shipments of its one-dose vaccine last month after U.S. federal regulators ended a 10-day pause in administering the doses while a potential link to a rare form of blood clot was examined.
The Moderna and Johnson & Johnson vaccines are currently only approved for for adults aged 18 and older.
Meanwhile, states had already begun sending the Pfizer vaccine to pediatricians in anticipation of Wednesday’s recommendation, according to The Associated Press.
DYAI’s C1 Technology May be Key in the Race to Vaccine-Induced Herd Immunity
Dyadic International Inc (NASDAQ: DYAI) is in an interesting position, being one of the very few names in the anti-Covid space that offer a new path that isn’t simply a reproduction or tie-in to the big pharma game right now.
DYAI has a new approach that isn’t new-age quote-unquote “science”, but a powerful new potential solution that holds the capacity to possibly become better able to deal with new variants and even possibly better able to drive cheap and efficient production capable of vaccinating the world compared to others such as: Astrazeneca (NASDAQ: AZN), Moderna Inc. (NASDAQ: MRNA), Novavax Inc. (NASDAQ: NVAX), Pfizer (NYSE: PFE), Johnson & Johnson (NYSE: NJ), and Biontech (NASDAQ: BNTX).
The company has now started to move toward collaborations that could produce the next major breakthrough in fighting Covid-19 over the long term, including vaccines that cover Covid-19 variants. In fact, DYAI believes it can produce trivalent and quadrivalent Covid-19 vaccines – ie a single vaccine that can cover three or even four variants of the virus simultaneously.
According to materials published by Dyadic International Inc (NASDAQ :DYAI), the C1 microorganism that forms the basis of its technology enables the development and large-scale manufacture of low-cost proteins and has the potential to be further developed into a safe and efficient expression system that may help speed up the development of biologic vaccines and drugs at commercial scales, while lowering production costs and improving performance at the same time.
There is still a lot of testing to be done. But the building blocks are potentially in place, and the company is moving forward with data-gathering activities that may produce game-changing results.
Dyadic’s Technology and Production Vectors
The technological breakthrough in play from DYAI has, most centrally, to do with vaccine production and the biological technology required to produce vaccines in large quantities.
Proteins associated with vaccine production are produced through a “vector”. The baculovirus–insect cell expression system is a commonly used vector and has been extensively utilized for the production of many recombinant proteins and commercial vaccines.
For example, for the production host of antigens for the Schmallenberg virus (SBV), we have comparative data. SBV antigens have been produced through both baculovirus–insect cell expression systems and through DYAI’s fungal system. As it turns out, the SBV antigen from C1 produced 300 times greater yields than the SBV antigen from baculovirus and was more stable.
Additionally, the C1 SBV antigen was shown to be safe and very effective (Full Protection) in protecting cattle and mice from the SBV.
DYAI believes its system could represent a breakthrough on a potentially significant scale as a biopharmaceutical gene expression platform. The key differentiating factor is that the DYAI system is based on the fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila), named C1.
The C1 microorganism is technically a fungal body, which differentiates its platform from other major vaccine programs.
Based on its SBV results, additional fully funded animal trials are continuing in 2021 with C1 expressed antigens for SBV and RVFV and to generate additional safety and efficacy data. The company is also beginning to test its platform as a system for generating results in the battle against Covid-19.
Why it Matters
According to Bloomberg, enough doses have now been administered to fully vaccinate 8.6% of the global population—but the distribution has been lopsided. Countries and regions with the highest incomes are getting vaccinated about 25 times faster than those with the lowest.
But new and potentially deadly variants can emerge anywhere and still end up taking over the world.
New variants are popping up almost weekly, it seems. Eventually, one will emerge that falls outside the efficacy range of our currently approved vaccines. The more people on the planet that remain unvaccinated, the faster such a threat will become a manifest reality.
In other words, either we find a faster, cheaper means of reaching vaccine-induced herd immunity, or we may be headed back into a new chapter in an ongoing pandemic crisis.
If DYAI’s CI-based platform is able to prove itself as a solution that can produce more vaccine doses at a lower cost without sacrificing efficacy, then it could represent an important breakthrough that changes the course toward a less vulnerable path.DISCLAIMER: EDM Media LLC (EDM), is a third-party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. EDM is NOT affiliated in any manner with any company mentioned herein. EDM and its affiliated companies are a news dissemination solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses, and may NOT sell, offer to sell or offer to buy any security. EDM’s market updates, news alerts, and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release. EDM is not liable for any investment decisions by its readers or subscribers. Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. For current services performed EDM has been compensated six thousand dollars for news coverage of the current press releases issued by Dyadic International Inc (NASDAQ: DYAI) by a third party.
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South Carolina Governor Bans Mask Mandates
South Carolina Gov. Henry McMaster issued a coronavirus mandate Tuesday preventing schools and local governments from creating mask mandates. His order also bans the use of so-called “vaccine passports” in the state.
Under the 15 page executive order, parents — not public school officials or school districts — will decide whether their student wears a mask in class.
“We have known for months that our schools are some of the safest places when it comes to COVID-19,” said McMaster in a statement. “With every adult in our state having the opportunity to receive a vaccine, it goes against all logic to continue to force our children – especially our youngest children – to wear masks against their parents’ wishes.”
McMaster ordered the South Carolina Department of Health and Environmental Control, in consultation with state’s Department of Education, to develop and distribute a standardized form parents and legal guardians may sign to opt their child out of mask requirements.
County or other local governments in South Carolina are also explicitly prohibited from relying on earlier public health orders or using a state of emergency to require masks.
“Everybody knows what we need to do to stay safe – including wearing a mask if you’re at risk of exposing others – but we must move past the time of governments dictating when and where South Carolinians are required to wear a mask,” McMaster said. “Maintaining the status quo ignores all of the great progress we’ve made.”
Tuesday’s executive order also explicitly prevents “any local government, state agency, state employee, or any political subdivision of the state” from requiring residents to provide proof of their vaccination status.
Vaccine passports have been pitched as a way to allow people to show proof of immunization from COVID-19 to gain access to certain events, businesses, or to travel.
McMaster called such a requirement “un-American to its core.”
Cases of COVID-19 in South Carolina have trended downward, like much of the rest of the country, according to state data. As of Tuesday afternoon, the state was reporting a 4.1% positivity rate and 95 probable cases of the virus. McMaster’s executive order also states 43% of eligible adults in South Carolina received at least one dose of a COVID-19 vaccine so far.
Despite the downward trend in confirmed cases, public health official have cautioned against reopening and ditching face coverings too soon.
National trends show the patients being hospitalized with COVID-19 now are overwhelmingly young and middle-aged adults.
Masks have repeatedly been shown to prevent the spread of COVID-19, and the Centers for Disease Control and Prevention still recommends people wear them, even if they’ve been vaccinated.
South Carolina joins Florida in loosening its coronavirus restrictions. Last week, Florida Gov. Ron DeSantis invalidated county and city rules requiring face masks, or imposing social distancing guidelines.
New York, New Jersey, and Connecticut all announced in the coming weeks that they, too will end most COVID-19 restrictions.
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