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FDA authorizes Moderna’s COVID-19 vaccine for emergency use

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for Moderna’s COVID-19 vaccine, as expected after an independent panel commissioned by the administration recommended its approval earlier this week. This is the second vaccine now authorized for use in the U.S. under EUA, after the Pfizer -BioNTech vaccine was approved last week.

Moderna’s vaccine could begin being administered to Americans by “Monday or Tuesday” next week, according to Dr. Anthony Fauci speaking to NBC’s Today show in a new interview. That’s in keeping with the timelines between the Pfizer EUA and the first patients actually receiving the vaccine last week.

Like Pfizer’s vaccine, Moderna’s is an mRNA therapy. That means that it contains no actual virus — just genetic instructions that tell a person’s body to create a specific protein. That protein is more or less identical to the one that SARS-CoV-2, the virus which causes COVID-19, uses to attach to a host’s cells and replicate. Moderna’s vaccine causes a person to create just the protein, which on its own is harmless, and then their natural defenses via their immune system react to that and develop a method for fighting it off. That defense system is “remembered” by the body, while the vaccine itself naturally dissolves after a brief time, leaving a person with immunity but nothing else.

The Oxford-AstraZeneca vaccine, which has yet to be approved for use in the U.S., uses a weakened and modified common cold virus that doesn’t spread in humans to create the spike protein in recipients, resulting in the body generating its own immune response. That’s a much more tried-and-tested method for creating a vaccine, but both Moderna and Pfizer’s mRNA therapies have shown to be very effective in preliminary data from their large Phase 3 clinical trials.

FDA grants emergency use authorization for Pfizer’s COVID-19 vaccine, distribution to begin within days

The U.S. Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) for the COVID-19 vaccine developed by Pfizer and its partner BioNTech, the New York Times first reported on Friday night, and later supported by The Wall Street Journal. This EUA follows a recommendation by an independent panel of experts commissioned by the FDA to review Pfizer’s application and provide a recommendation, which the panel unanimously supported earlier this week.

Following this authorization, shipment of the vaccine are expected to begin immediately, with 2.9 million doses in the initial shipment order. Patients in the category of highly vulnerable individuals, which include healthcare workers and senior citizens in long-term care facilities, are expected to begin receiving doses within just a few days not was the EUA is granted.

This approval isn’t a full certification by the U.S. therapeutics regulator, but it is an emergency measure that still requires a comprehensive review of the available information supplied by Pfizer based on its Phase 3 clinical trial, which covered a group of 44,000 volunteer participants. Pfizer found that its vaccine, which is an mRNA-based treatment, was 95% effective in its final analysis of the data resulting form the trial to date – and also found that safety data indicated no significant safety issues in patients who received the vaccine.

On top of the initial 2.9 million dose order, the U.S. intends to distribute around 25 million doses by the end of 2020, which could result in far fewer people actually vaccinated since the Pfizer course requires two innoculations for maximum efficacy. Most American shouldn’t expect the vaccine to be available until at least late Q1 or Q2 2021, given the pace of Pfizer’s production and the U.S. order volume.

Still, this is a promising first step, and a monumental achievement in terms of vaccine development turnaround time, since it’s been roughly eight months since work began on the Pfizer vaccine candidate. Moderna has also submitted an EUA for its vaccine candidate, which is also an mRNA treatment (which provides instructions to a person’s cells to produce effective countermeasures to the virus). That could follow shortly, meaning two vaccines might be available under EUA within the U.S. before the end of the year.

A new FDA-authorized COVID-19 test doesn’t need a lab and can produce results in just 5 minutes

There’s a new COVID-19 test from healthcare technology maker Abbott that looks to be the fastest yet in terms of producing results, and that can do so on the spot right at point-of-care, without requiring a round trip to a lab. This test for the novel coronavirus causing the current global pandemic has received emergency clearance for use by the U.S. Food and Drug Administration, and will begin production next week, with output of 50,000 per day possible starting next week.

The new Abbott ID NOW COVID-19 test uses the Abbott ID NOW diagnostics platform, which is essentially a lab-in-a-box that is roughly the size of a small kitchen appliance. It’s size, and the fact that it can produce either a positive result in just five minutes, or a negative one in under 15, mean that it could be a very useful means to extend coronavirus testing beyond its current availability to more places including clinics and doctor’s offices, and cut down on wait times both in terms of getting tested and receiving a diagnosis.

Unlike the rapid tests that have been used in other countries, and that received a new type of authorization under an FDA guideline that doesn’t confirm the accuracy fo the results, this rapid testing solution uses the molecular testing method, which works with saliva and mucus samples swabbed from a patient. This means that it works by identifying a portion of the virus’ DNA in a patient, which means it’s much better at detecting the actual presence of the virus during infection, whereas other tests that search the blood for antibodies that are used in point-of-care settings can only detect antibodies, which might be present in recovered patients who don’t actively have the virus.

The good news for availability of this test is that ID NOW, the hardware from Abbott that it runs on, already “holds the largest molecular point-of-care footprint in the U.S.,” and is “widely available” across doctor’s offices, urgent care clinics, emergency rooms and other medical facilities.

In total, Abbott now says that it believes it will produce 5 million tests in April, split between these new rapid tests and the lab tests that it received emergency use authorization for by the FDA on March 18.

Testing has been one of the early problems faced by the U.S. in terms of getting a handle on the coronavirus pandemic: The country has lagged behind other nations globally in terms of per capita tests conducted, which experts say has hampered its ability to properly track and trace the spread of the virus and its resulting respiratory disease. Patients have reported having to go to extreme lengths to receive a test, and endure long waits for results, even in cases where exposure was likely and their symptoms match the COVID-19 profile.

YC startup Felix wants to replace antibiotics with programmable viruses

Right now the world is at war. But this is no ordinary war. It’s a fight with an organism so small we can only detect it through use of a microscope — and if we don’t stop it, it could kill millions of us in the next several decades. No, I’m not talking about COVID-19, though that organism is the one on everyone’s mind right now. I’m talking about antibiotic-resistant bacteria.

You see, more than 700,000 people died globally from bacterial infections last year — 35,000 of them in the U.S. If we do nothing, that number could grow to 10 million annually by 2050, according to a United Nations report.

The problem? Antibiotic overuse at the doctor’s office or in livestock and farming practices. We used a lot of drugs over time to kill off all the bad bacteria — but it only killed off most, not all, of the bad bacteria. And, as the famous line from Jeff Goldblum in Jurassic Park goes, “life finds a way.”

Enter Felix, a biotech startup in the latest Y Combinator batch that thinks it has a novel approach to keeping bacterial infections at bay – viruses.

Phage killing bacteria in a petri dish

It seems weird in a time of widespread concern over the corona virus to be looking at any virus in a good light but as co-founder Robert McBride explains it, Felix’s key technology allows him to target his virus to specific sites on bacteria. This not only kills off the bad bacteria but can also halt its ability to evolve and once more become resistant.

But the idea to use a virus to kill off bacteria is not necessarily new. Bacteriophages, or viruses that can “infect” bacteria, were first discovered by an English researcher in 1915 and commercialized phage therapy began in the U.S. in the 1940’s through Eli Lilly and Company. Right about then antibiotics came along and Western scientists just never seemed to explore the therapy further.

However, with too few new solutions being offered and the standard drug model not working effectively to combat the situation, McBride believes his company can put phage therapy back at the forefront.

Already Felix has tested its solution on an initial group of 10 people to demonstrate its approach.

Felix researcher helping cystic fibrosis patient Ella Balasa through phage therapy

“We can develop therapies in less time and for less money than traditional antibiotics because we are targeting orphan indications and we already know our therapy can work in humans,” McBride told TechCrunch . “We argue that our approach, which re-sensitizes bacteria to traditional antibiotics could be a first line therapy.”

Felix plans to deploy its treatment for bacterial infections in those suffering from cystic fibrosis first as these patients tend to require a near constant stream of antibiotics to combat lung infections.

The next step will be to conduct a small clinical trial involving 30 people, then, as the scientific research and development model tends to go, a larger human trial before seeking FDA approval. But McBride hopes his viral solution will prove itself out in time to help the coming onslaught of antibiotic resistance.

“We know the antibiotic resistant challenge is large now and is only going to get worse,” McBride said. “We have an elegant technological solution to this challenge and we know our treatment can work. We want to contribute to a future in which these infections do not kill more than 10 million people a year, a future we can get excited about.”

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