John Parkinson

The first over-the-counter at-home diagnostic test for coronavirus disease 2019 (COVID-19) was granted emergency use authorization (EUA) by the US Food and Drug Administration (FDA) yesterday. The EUA was for the Ellume COVID-19 Home Test.

FDA Commissioner Stephen M. Hahn, MD, called the EUA “a major milestone in diagnostic testing for COVID-19. By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes.”

 to Lucira Health for it’s at-home, self-administered COVID test which can be purchased with a prescription. Since the beginning of the pandemic, the agency has authorized more than 225 COVID-19 diagnostic tests, including more than 25 tests that allow for home collection of samples, which are then sent to a lab for testing.

“As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes,” Hahn said.

The test may prove especially useful during this second wave of COVID-19.

According to the COVID Tracking Project, yesterday was a record-breaking day in terms of people being hospitalized for COVID-19: 112,816 people were hospitalized for COVID yesterday, the most ever. The next four highest days for hospitalization? They are December 14, 13, 12, and 11—the four previous days.

According to Johns Hopkins University, there were 189,357 confirmed cases of COVID-19 yesterday while 3019 people died from the disease. That’s the third highest one-day death toll for the disease in the United States since the pandemic began.

Overall, in the United States there have been nearly 17 million confirmed cases of COVID-19. And, in the United States, over 300,000 people have died from the disease. In the world, there have been over 70 million confirmed cases of COVID-19. And, in the world, over 1.6 million people have died from the disease.

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This non-prescription test allows users to perform and get results themselves without a medical provider or laboratory needed.

Over-the-Counter, At-Home COVID Test Approved

AstraZeneca reported today its investigational COVID-19 vaccine, AZD1222, was 90% efficacious in 1 of their 2 dosing regimens. With this news, the company is planning to submit their data to regulatory bodies for conditional or early approval.

When the vaccine was given as a half dose, then a full dose 1 month apart, the vaccine had a 90% efficacy. The company also did a second dosing regimen giving participants 2 full doses one month apart, and that showed 62% efficacy. According to AstraZeneca, the combined analysis from both dosing regimens resulted in an average efficacy of 70%.

The data come from trials performed in the United Kingdom and Brazil. There were a total of 131 COVID-19 cases in the interim analysis. The pooled analysis included data from the COV002 Phase 2/3 trial in the UK and COV003 Phase 3 trial in Brazil. Over 23000 participants are being assessed.

An independent data safety monitoring board determined that the analysis met its primary endpoint showing protection from COVID-19 occurring 14 days or more after receiving 2 doses of the vaccine. They also report no serious safety events related to the vaccine.

“These findings show that we have an effective vaccine that will save many lives. Excitingly, we’ve found that one of our dosing regimens may be around 90% effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply,” said Andrew Pollard, PhD, chief investigator of the Oxford Vaccine Trial at Oxford, said.

The company is looking at a capacity of up to 3 billion doses of the vaccine in 2021 on a rolling basis, pending regulatory approval.

One of the differences between the AstraZeneca vaccine and the Pfizer vaccine is the storage conditions. The former vaccine can be stored, transported and handled at normal refrigerated conditions (2-8 degrees Celsius/36-46 degrees Fahrenheit) for at least 6 months and administered within existing healthcare settings. The Pfizer vaccine supply requires they stay at a temperature of -70 degrees Celsius.

Data show that AstraZeneca’s AZD1222 vaccine met its endpoint and the company is preparing regulatory submission for conditional or early approval.

AstraZeneca Investigational COVID-19 Vaccine Shown to be 90% Efficacious

The herd immunity approach championed by the Great Barrington Declaration would, if actually put into practice, prove disastrous for society as a whole and the healthcare system in particular. That’s the message in a memorandum that was written by 80 international researchers and published in 

 this week. That open letter, called the John Snow Memorandum, warns that a herd immunity approach to managing COVID-19 by allowing immunity to develop in low-risk populations while protecting the most vulnerable is “a dangerous fallacy unsupported by the scientific evidence.” That’s also a point made by Kevin Kavanagh, MD, a member of 

Kavanagh wrote that “for infection preventionists and frontline healthcare workers, the Great Barrington Declaration places their lives and livelihood at risk.”

The authors of the John Snow Memorandum come from a variety of medical specialties including public health, epidemiology, medicine, pediatrics, sociology, virology, infectious disease, health systems, psychology, psychiatry, health policy, and mathematical modeling.

In the memorandum, the authors speak of success in some countries who have employed COVID-19 containment strategies.

“Japan, Vietnam, and New Zealand, to name a few countries, have shown that robust public health responses can control transmission, allowing life to return to near-normal, and there are many such success stories,” the authors wrote in the memorandum.

They also advocated for the continued approach to minimize risk of transmission. “The evidence is very clear: controlling community spread of COVID-19 is the best way to protect our societies and economies until safe and effective vaccines and therapeutics arrive within the coming months. We cannot afford distractions that undermine an effective response; it is essential that we act urgently based on the evidence.”

The memorandum authors did acknowledge that ongoing restrictions have understandably led to widespread demoralization and diminishing trust among the public, and that in the face of a second wave of infection there is renewed interest in natural herd immunity approaches.

However, they say any pandemic management strategy relying upon immunity from natural infections for COVID-19 is flawed.

, spoke to one of the declaration’s authors, Martin Kulldorff, PhD, Professor of Medicine at Harvard Medical School & Brigham and Women’s Hospital. He spoke on a number of topics including the age-targeted approach to dealing with COVID-19. To view that interview and learn more about the declaration, click 

A letter signed by 80 researchers says the concept put forth by the Great Barrington Declaration is “a dangerous fallacy.”

Experts Forcefully Push Back on Barrington Declaration

The US government announced this morning it is going to buy the Pfizer and BioNTech 

The U.S. government will pay the companies $1.95 billion upon the receipt of the first 100 million doses, following US Food and Drug Administration (FDA) authorization or approval. The U.S. government also can acquire up to an additional 500 million doses.

“Expanding Operation Warp Speed’s diverse portfolio by adding a vaccine from Pfizer and BioNTech increases the odds that we will have a safe, effective vaccine as soon as the end of this year,” HHS Secretary Alex Azar said. “Depending on success in clinical trials, today’s agreement will enable the delivery of approximately 100 million doses of this vaccine to the American people.”

 status of the companies’ 2 COVID-19 vaccines. The BNT162b1 and BNT162b1 are the investigational vaccines given the go-ahead and is a joint research venture between the biopharmaceutical companies.

“We made the early decision to begin clinical work and large-scale manufacturing at our own risk to ensure that product would be available immediately if our clinical trials prove successful and an Emergency Use Authorization is granted,” Pfizer Chairman and CEO Albert Bourla said.

“We are honored to be a part of this effort to provide Americans access to protection from this deadly virus.”

 follows the UK’s decision to buy the two companies’ vaccine earlier this week.

The development shows just how fast the process of finding a COVID-19 vaccine is moving under the government’s Project Lightspeed vaccine approval program. Officials of the 2 companies said last week that they planned to take the FDA’s approval and run with it.

“The FDA’s decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2,” Peter Honig, senior vice president, Global Regulatory Affairs, Pfizer, said last week. “We look forward to continue working closely with the FDA throughout the clinical development of this program, Project Lightspeed, to evaluate the safety and efficacy of these vaccine candidates.”

Project Lightspeed is based on BioNTech’s proprietary mRNA-based technology platforms and supported by Pfizer’s global vaccine development capabilities. The vaccine candidates are undergoing clinical studies and are not currently approved for distribution anywhere in the world.

“We are pleased to have received Fast Track designation from the FDA for two of our vaccine candidates and look forward to working closely with the FDA, along with our partner Pfizer, to expedite the clinical development path forward,” Chief Medical Officer Özlem Türeci at BioNTech reiterated.

As this is breaking news, stay tuned for future developments.

The U.S. government will pay Pfizer and BioNTech $1.95 billion upon the receipt of the first 100 million doses, following US Food and Drug Administration (FDA) authorization or approval. The U.S. government also can acquire up to an additional 500 million doses.


John Parkinson

Articles

Over-the-Counter, At-Home COVID Test Approved

AstraZeneca Investigational COVID-19 Vaccine Shown to be 90% Efficacious

Experts Forcefully Push Back on Barrington Declaration

US Government Buying 100 Million Doses of COVID-19 Vaccine