COVID-19 Update: Adagio Gunning for EUA and mRNA Boosters Recommended

COVID-19 Vaccine_Darrian Traynor/Getty Images

Darrian Traynor/Getty Images

Although it looks — keep your fingers crossed — that we’re on the downside of the COVID-19 pandemic in the United States, biopharma companies are still working on developing better treatments and preventions. Public health experts are keeping a close eye on the now-dominant Omicron subvariant BA.2 and ways of mitigating the spread of the virus. For those and more COVID-19 stories, continue reading.

Adagio's Monoclonal Antibody Ready for EUA 

Adagio Therapeutics announced that its Phase II/III trials evaluating adintrevimab as pre-and post-exposure prophylaxis (EVADE) and treatment (STAMP) for COVID-19 hit the primary endpoints. Adintevimab is a potent, broadly neutralizing antibody against SARS-CoV-2. Administered intramuscularly, it had a similar safety profile to a placebo. The company expects to submit an Emergency Use Authorization to the U.S. Food and Drug Administration soon.

Michael Ison, M.D., professor of Medicine in the Division of Infectious Diseases and of Surgery in the Division of Organ Transplantation, Northwestern University Feinberg School of Medicine, said, “The compelling data generated on adintrevimab in both of Adagio’s clinical trials represent an important step toward further addressing the continuation of the COVID-19 pandemic. I am particularly encouraged by the consistent treatment effect observed across all three clinical settings and patient subpopulations, and the favorable safety profile, with just a single dose and convenient IM delivery for all patients. The risk reduction in the post-exposure prophylaxis setting regardless of serostatus translates to real-world use when clinicians might not know the vaccination or prior infection status of their patients. In the STAMP trial, adintrevimab showed prevention of hospitalization and death in the face of the ‘highest-risk’ variant (Delta) to date.”

The study was conducted ahead of the Omicron surge.

CDC Recommends mRNA Booster if You Received J&J COVID-19 Vaccination

The U.S. Centers for Disease Control and Prevention recommend that the 17 million Americans given the single-shot Johnson & Johnson COVID-19 vaccine consider getting a booster with one of the mRNA vaccines from Pfizer-BioNTech or Moderna. They should also consider a second mRNA booster for the best protection. The recommendation is based on an analysis of data of so-called “mix and match” vaccines and boosters during the four months of the Omicron surge. The data found that even the J&J shot with a booster of J&J or one of the mRNA vaccines wasn’t as effective as three shots of the mRNA vaccines in preventing ER visits or hospitalizations.

Omicron Sister Variant (BA.2) Now Dominant Strain in the U.S.

As expected, the Omicron subvariant BA.2 is now the dominant strain in the U.S., according to the CDC. Believed to be anywhere from 30% to 50% more infectious than the original Omicron variant, BA.1, it does not appear to cause more severe disease. And so far, at least, it is not associated with significant increases in hospitalizations or deaths. It was reported to make up more than 70% of COVID-19 cases in New York. Overall, cases in the U.S. appear to be dropping, and per CDC’s calculations, more than 91% of the U.S. falls into a low-risk category.

In a related story, the CDC conducted a survey of blood donor samples in December and then updated the data in February, finding that about 95% of people in the U.S. 16 years and older have identifiable SARS-CoV-2 antibodies. This indicates that most people have been exposed to COVID-19 or received vaccinations at least in the blood donor population. About 77% of the U.S. population has received at least one COVID-19 vaccine.

CDC Calculator: When Should You Quarantine?

The CDC released an online calculator to assist people in deciding if they should isolate or quarantine after being diagnosed with COVID-19 or being exposed. After answering a few questions, the calculator will make recommendations on whether you should isolate, quarantine, get tested and how long you should take precautions such as masking. The program differentiates between isolating and quarantine, with isolation for mild or no symptoms, but testing positive. Quarantine is for close contact with a COVID-19-positive person but without testing positive.

Fauci: Be Prepared for More Surges and Restrictions

Although current trends generally look positive, public health experts and epidemiologists note how unpredictable COVID-19 has been. As a result, Dr. Anthony Fauci, White House chief medical adviser and director of the National Institute of Allergy and Infectious Diseases, told BBC’s “Sunday Morning,” that people in the U.S. “need to be prepared for the possibility” of more restrictions if another surge occurs. He added, “I don’t want to use the word ‘lockdowns.’ That has a charged element to it. But I believe that we must keep our eye on the pattern of what we’re seeing with infections.”

New COVID-19 Focus: Indoor Air Quality

Numerous research studies determined that poor indoor ventilation helped spread the virus during the pandemic. The Biden administration is taking that into account now, urging businesses, homeowners and schools to improve air quality.

“The most common way COVID-19 is transmitted from one person to another is through tiny airborne particles of the virus hanging in indoor air for minutes or hours after an infected person has been there,” Dr. Alondra Nelson, head of the White House Office of Science and Technology Policy, wrote in a blog last week. “While there are various strategies for avoiding breathing that air — from remote work to masking — we can and should talk more about how to make indoor environments safer by filtering or cleaning air.”

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