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FDA OKs mixing COVID vaccines; backs Moderna, J&J boosters

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U.S. regulators on Wednesday signed off on extending COVID-19 boosters to Americans who got the Moderna or Johnson & Johnson vaccine and said anyone eligible for an extra dose can get a brand different from the one they received initially.

The Food and Drug Administration’s decisions mark a big step toward expanding the U.S. booster campaign, which began with extra doses of the Pfizer vaccine last month. But before more people roll up their sleeves, the Centers for Disease Control and Prevention will consult an expert panel Thursday before finalizing official recommendations for who should get boosters and when.

The latest moves would expand by tens of millions the number of Americans eligible for boosters and formally allow “mixing and matching” of shots — making it simpler to get another dose, especially for people who had a side effect from one brand but still want the proven protection of vaccination.

Specifically, the FDA authorized a third Moderna shot for seniors and others at high risk from COVID-19 because of their health problems, jobs or living conditions — six months after their last shot. One big change: Moderna’s booster will be half the dose that’s used for the first two shots, based on company data showing that was plenty to rev up immunity again.

For J&J’s single-shot vaccine, the FDA said all U.S. recipients, no matter their age, could get a second dose at least two months following their initial vaccination.

The FDA rulings differ because the vaccines are made differently, with different dosing schedules — and the J&J vaccine has consistently shown a lower level of effectiveness than either of the two-shot Moderna and Pfizer vaccines.

As for mixing and matching, the FDA said it’s OK to use any brand for the booster regardless of which vaccination people got first. The interchangeability of the shots is expected to speed the booster campaign, particularly in nursing homes and other institutional settings where residents have received different shots over time.

FDA officials said they wanted to make the booster guidance as flexible as possible, given that many people don’t remember which brand of vaccine they received.

“Being able to interchange these vaccines is a good thing — it’s like what we do with flu vaccines,” FDA’s Dr. Peter Marks told reporters Wednesday evening. “Most people don’t know what brand of flu vaccine they received.”

Still, he added that many people will decide to get a booster from the same company as their initial vaccination.

The agency’s mix-and-match decision was based on preliminary results from a government study of different booster combinations that showed an extra dose of any type revs up levels of virus-fighting antibodies. That study also showed recipients of the single-dose J&J vaccination had a far bigger response if they got a full-strength Moderna booster or a Pfizer booster rather than a second J&J shot. The study didn’t test the half-dose Moderna booster.

Health authorities stress that the priority still is getting first shots to about 65 million eligible Americans who remain unvaccinated. But the booster campaign is meant to shore up protection against the virus amid signs that vaccine effectiveness is waning against mild infections, even though all three brands continue to protect against hospitalization and death.

“Today the currently available data suggest waning immunity in some populations of fully vaccinated people,” said FDA’s acting commissioner Dr. Janet Woodcock. “The availability of these authorized boosters is important for continued protection against COVID-19 disease.”

The Moderna booster decision essentially matches FDA’s ruling that high-risk groups are eligible for the Pfizer vaccine, which is made with the same technology.

FDA recommended that everyone who’d gotten the single-shot J&J vaccine get a booster since it has consistently shown lower protection than its two-shot rivals. And several independent FDA advisers who backed the booster decision suggested J&J’s vaccine should have originally been designed to require two doses.

Experts continue to debate the rationale of the booster campaign. Some warn that the U.S. government hasn’t clearly articulated the goals of boosters given that the shots continue to head off the worst effects of COVID-19, and wonder if the aim is to tamp down on virus spread by curbing, at least temporarily, milder infections.

FDA regulators said they would move quickly to expand boosters to lower age groups, such as people in their 40s and 50s, if warranted.

“We are watching this very closely and will take action as appropriate to make sure that the maximum protection is provided to the population,” said Marks, the FDA’s top vaccine official.

In August, the Biden administration announced plans for an across-the-board booster campaign aimed at all U.S. adults, but outside experts have repeatedly argued against such a sweeping effort.

On Thursday an influential panel convened by the CDC is expected to offer more specifics on who should get boosters and when. Their recommendations are subject to approval by the CDC director.

The vast majority of the nearly 190 million Americans who are fully vaccinated against COVID-19 have received the Pfizer or Moderna options, while about 15 million have received the J&J vaccine.


WASHINGTON (AP)

MedTech

Why BioTech is important

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Biotechnology has many advantages including helping improve food quality, quantity, and processing, as well as also has having functions in manufacturing, where simple cells and proteins can be manipulated to produce chemicals.

The source of biotechnology comes from the fact that technology aims to create tools to empower humans, aiming to change humans themselves to better fit them to the world. Also, Biotechnology is the application of advances made in the biological sciences, especially involving the science of genetics and its application.

Its implications in health and medicine gives the importance of Biotechnology, by having scientists being able through genetic engineering, which is the controlled alteration of genetic material, to create new medicines, including interferon for cancer patients, synthetic human growth hormone and synthetic insulin, among others.

As such, the significance of biotechnology is shown by having scientists use the tools of biotechnology to manipulate cells with increasing control, from precision editing of DNA to synthesizing entire genomes from their basic chemical building blocks. These cells could go on to become bomb-sniffing plants, miracle cancer drugs, or ‘de-extinct’ wooly mammoths, and biotechnology may be a crucial ally in the fight against climate change according to the Future of Life Institute.

“The impact of biotech is huge on people’s lives, having the majority of the food we eat coming from engineered plants, which are modified – either via modern technology or by more traditional artificial selection – to grow without pesticides, to require fewer nutrients, or to withstand the rapidly changing climate,” the institute added.

“Manufacturers have substituted petroleum-based ingredients with biomaterials in many consumer goods, such as plastics, cosmetics, and fuels. Your laundry detergent? It almost certainly contains biotechnology. So do nearly all of your cotton clothes,” it noted.

Even so, biotech is present in our detailed lives, helping us in every way possible, such as the assistance to prenatal screening and home pregnancy test, in addition to immunizations and antibiotics, which improved life expectancy. Also, biotechnology is the main reason for many drugs that heal diseases such as cancer and heart disease.

On the other hand, biotechnology has its own disadvantages and consequences for the fact that microbes are tiny and difficult to detect, however the dangers are enormous. Further, engineered cells could divide on their own and spread in the wild, with the possibility of far-reaching consequences.

The unintended consequences of benign research or the purposeful manipulation of biology to cause harm, are factors that prove that biotechnology can be harmful.

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iSTAR gains European approval for implant for glaucoma surgery

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While glaucoma is the leading cause of irreversible blindness affecting around 100 million people worldwide, iSTAR Medical, a Belgium-based medtech company pioneering novel minimally-invasive implants for glaucoma surgery (MIGS), announced Wednesday, that its breakthrough MIGS device, MINIject™, has been approved in Europe for open-angle glaucoma patients.

As such, MINIject enables more patients to be effectively treated with MIGS because of its powerful and sustained performance combined with an excellent safety profile.

In addition, it represents the most promising and fastest-growing glaucoma therapy, due to its enhanced safety profile compared to traditional surgery. Studies by iSTAR Medical across four trials in over 150 patients, show that MINIject demonstrates a balance of powerful and sustained intra-ocular pressure (IOP) reduction with a positive safety profile.

“With today’s European approval, MINIject becomes the only commercially available MIGS device targeting the supraciliary space as a natural outflow pathway for IOP reduction,” Michel Vanbrabant, CEO of iSTAR Medical, said.

“This is a major milestone for iSTAR Medical and our mission to bring truly next-generation MIGS devices to the glaucoma community,” he noted. “I want to thank our team, our investors, and our medical partners for their continued belief in a safer and better way to manage glaucoma by targeting the supraciliary space, with an implant powered by our proprietary STAR material,” the CEO added.

Professor Dr. Burkhard Dick, head of the Department of Ophthalmology at University Eye Hospital Bochum, Germany, and one of the MINIject STAR-II trial investigators, treated the first patient with MINIject after European approval.

 Moreover, MINIject is being investigated in iSTAR Medical’s pivotal STAR-V study, which was approved by the United States Food and Drug Administration (FDA) in July 2021, the results of which will be instrumental to gain commercial access for MINIject in the U.S. market.

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EU regulator authorizes Pfizer’s COVID vaccine for kids 5-11

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The European Union’s drug regulator on Thursday authorized Pfizer’s coronavirus vaccine for use on children from 5 to 11 years old, clearing the way for shots to be administered to millions of elementary school pupils amid a new wave of infections sweeping across the continent.

It is the first time the European Medicines Agency has cleared a COVID-19 vaccine for use in young children.

The agency said it “recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged 5 to 11.”

After evaluating a study of the vaccine in more than 2,000 children, the EMA estimated that the vaccine was about 90% effective in preventing symptomatic COVID-19 in young children and said the most common side effects were pain at the injection site, headaches, muscle pain and chills. The agency said the two-dose regimen should be given to children three weeks apart.

At least one country facing spiking infections didn’t wait for the EMA approval. Authorities in the Austrian capital, Vienna, already have begun vaccinating the 5 to 11 age group. Europe is currently at the epicenter of the pandemic and the World Health Organization has warned the continent could see deaths top 2 million by the spring unless urgent measures are taken.

The EMA green light for the vaccine developed by Pfizer and German company BioNTech has to be rubber-stamped by the EU’s executive branch, the European Commission, before health authorities in member states can begin administering shots.

Earlier this week, Germany’s health minister Jens Spahn said shipping of vaccines for younger children in the EU would begin on Dec. 20.

The United States signed off on Pfizer’s kids-sized shots earlier this month, followed by other countries including Canada.

Pfizer tested a dose that is a third of the amount given to adults for elementary school-age children. Even with the smaller shot, children who are 5 to 11 years old developed coronavirus-fighting antibody levels just as strong as teenagers and young adults getting the regular-strength shots, Dr. Bill Gruber, a Pfizer senior vice president, told The Associated Press in September.

But the studies done on Pfizer’s vaccine in children haven’t been big enough to detect any rare side effects from the second dose, like the chest and heart inflammation that has been seen in mostly male older teens and young adults.

American officials noted that COVID-19 has caused more deaths in children in the 5 to 11 age group than some other diseases, such as chickenpox, did before children were routinely vaccinated.

Earlier this month, the EMA said it began evaluating the use of Moderna Inc.’s COVID-19 vaccine for children ages 6 to 11; it estimated that a decision would be made within two months.

Although children mostly only get mild symptoms of COVID-19, some public health experts believe immunizing them should be a priority to reduce the virus’ continued spread, which could theoretically lead to the emergence of a dangerous new variant.

Researchers disagree on how much kids have influenced the course of the pandemic. Early research suggested they didn’t contribute much to viral spread. But some experts say children played a significant role this year spreading contagious variants such as alpha and delta.

In a statement this week, WHO said that because children and teens tend to have milder COVID-19 disease than adults, “it is less urgent to vaccinate them than older people, those with chronic health conditions and health workers.”

It has appealed to rich countries to stop immunizing children and asked them to donate their doses immediately to poor countries who have yet to give a first vaccine dose to their health workers and vulnerable populations.

Still, WHO acknowledged that there are benefits to vaccinating children and adolescents that go beyond the immediate health benefits.

“Vaccination that decreases COVID transmission in this age group may reduce transmission from children and adolescents to older adults, and may help reduce the need for mitigation measures in schools,” WHO said.


THE HAGUE, Netherlands (AP)

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