Coronavirus Breaking News

The coronavirus disease COVID-19 is currently reaching pandemic levels in various countries.

Aug 15, 2022 • 10:41 am CDT
by Gerd Altmann

The UK's Medicines and Healthcare products Regulatory Agency (UKHSA) announced today that Moderna's updated version of the COVID-19 vaccine targeting two SARS-CoV-2 coronavirus variants had been approved for adult booster doses.

In each booster vaccine dose, 'Spikevax bivalent Original/Omicron,' half of the vaccine (25 micrograms) targets the original virus strain from 2020, and the other half (25 micrograms) targets Omicron.

The Medicines and Healthcare products Regulatory Agency's (MHRA) decision is based on data from a clinical trial that showed that a booster with the bivalent  Moderna vaccine triggers a strong immune response against both Omicron (BA.1) and the original 2020 strain.

In an exploratory analysis, the bivalent vaccine was also found to generate a good immune response against the Omicron sub-variants BA.4 and BA.5.

Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines, commented in a press release issued on August 15, 2022, "The Commission on Human Medicines and its COVID-19 Vaccines Expert Working Group has independently reviewed the data on safety, quality, and effectiveness and agrees with the MHRA's decision."

"The virus, SARS-CoV-2, continually evolves to evade the immunity provided by vaccines."

"This novel bivalent vaccine represents the next step in the development of vaccines to combat the virus, with its ability to lead to a broader immune response than the original vaccine."

Furthermore, the Joint Committee on Vaccination and Immunisation will advise on how this Moderna vaccine should be offered as part of the deployment program.

Note: The UK press release was manually translated and curated for mobile readership.

Aug 13, 2022 • 6:18 am CDT
U.S. CDC

The U.S. CDC recently announced it was streamlining its COVID-19 guidance to help people better understand their risk, how to protect themselves and others, what actions to take if exposed to COVID-19, and what actions to take if they are sick or test positive for the virus.

"We're in a stronger place today as a nation, with more tools—like vaccination, boosters, and treatments—to protect ourselves and our communities from severe illness from COVID-19," said Greta Massetti, Ph.D., MPH, MMWR author, in a media statement August 11, 2022.

"We also have a better understanding of how to protect people from being exposed to the virus, like wearing high-quality masks, testing, and improved ventilation."

"This guidance acknowledges that the pandemic is not over, but also helps us move to a point where COVID-19 no longer severely disrupts our daily lives."

In support of this update, the CDC continues to promote the importance of being up to date with vaccination to protect people against serious illness, hospitalization, and death.

The protection provided by the current vaccine against symptomatic infection and transmission is less than that against severe disease.

And COVID-19 vaccine protection diminishes over time, especially against the currently circulating variants.

For this reason, it is essential to stay up to date, especially as new vaccines become available, says the CDC.

On August 11, 2022, the WHO reported that in Israel, during the Omicron dominant period, the estimated vaccine effectiveness (VE) of BNT162b2 against symptomatic COVID19 was 18% (95% CI, −2 to 34) at 14 to 27 days after the first dose and 48% (95% CI, 29 to 63) at 7 to 21 days after the second dose.

Additional COVID-19 vaccine news is posted at CoronavirusToday.

Aug 9, 2022 • 3:12 pm CDT
by Gerd Altmann

Georgia-based Frontier Biotechnologies recently announced positive results from the Phase 1 clinical trial of its drug candidate, FB2001, in healthy adult volunteers.

FB2001 (Bofutrelvir) is a small molecule inhibitor of coronavirus main protease (Mpro).

A total of 120 participants received intravenous infusions of FB2001 at either single doses from 5 mg to 400 mg or multiple doses of 30 mg to 400 mg daily for five days.

The key findings from the study are as follows:

  • FB2001 was safe and well tolerated up to 400 mg per day
  • Without a pharmacokinetic enhancer, FB2001 exhibited plasma and lung drug concentrations above the in vitro antiviral EC50 value.
  • No significant difference was observed between the Chinese and American populations.

The current intravenous formulation of FB2001 is ideal for hospitalized patients with its rapid onset of action and is suited for patients with dysphagia or other problems with swallowing, says the company.

Working with clinical research organizations, regional regulatory agencies, and local clinical centers, Frontier Biotechnologies has started a pivotal Phase 2/3 study (BRIGHT trial) to enroll about 1,200 hospitalized patients in hundreds of clinical centers worldwide.

"The phase 1 data were really promising", said Dr. Michael Hu, Chief Medical Officer of Frontier Biotechnologies, "and we are confident to carry out the pivotal trial to explore the utility of the drug in reducing the time to recovery in hospitalized patients due to COVID-19."

Frontier Biotechnologies is also developing a pulmonary formulation of FB2001 that could be used in out-patient settings for the treatment of mild Covid-19, as well as for post-exposure prophylaxis.

When inhaled directly into the respiratory tract and lungs, the tissue concentration of FB2001 is much higher than that in plasma; hence, the onset of action and viral clearance could potentially be faster than that of oral therapy. 

Note: This announcement was manually curated for mobile readership.

Aug 9, 2022 • 9:09 am CDT
by Bob from Pixabay

The Danish Health Authority (DHA) recently confirmed that 'many Danes have been vaccinated with COVID-19, and many have also been infected with the virus that causes COVID-19. 

Therefore, immunity in Denmark's population is very high.

 Against this background, the vaccination program against COVID-19 has been completed for the current season as of May 2022.

Furthermore, children and young people rarely become seriously ill from COVID-19 from the SARS-CoV-2 virus variant known as Omicron. 

Therefore, from July 2022, initial COVID-19 vaccinations are no longer possible for most people under the age of 18.

And effective September 1, 2022, most young people will not be able to get the 2nd COVID-19 vaccination, reported the DHA.

However, 'quite a few children with a particularly increased risk of a serious course will have the option of vaccination, after an individual assessment by a doctor.'

And the DHA confirmed plans to resume its COVID-19 vaccination program for target groups in the autumn and winter season 2022/23.

The DHA stated on July 4, 2022, that it intends to offer booster vaccinations to people aged 50 and over in the autumn.

There will also be an offer for particularly vulnerable people under 50, e.g., people with severely weakened immune systems who a doctor has assessed would benefit from vaccination.

Note: This announcement was translated and curated for mobile readership.

Aug 7, 2022 • 5:50 am CDT
by Gerd Altmann

The Financial Times reported yesterday Emer Cooke, head of the European Medicines Agency (EMA), said in an interview that reviewing 'available (COVID-19 vaccine) data was paramount and that her agency would stand firm.'

"Irrespective of what is happening, we have to have confidence in the vaccines that we authorize, and that is our primary responsibility as we have done with all the vaccines that have been presented to us."

"All this comparison between BA.1 and BA.4/BA.5 is something I think we're over-focusing on at the moment," Cooke added on August 6, 2022.

"Promises are not enough for me."

'We are working towards possible approvals of adapted vaccines in September,' said Cooke in July 2022.

Previously, the European Centre for Disease Prevention and Control and the EMA recommended that second booster doses of the current mRNA COVID-19 vaccines be considered for people between 60 and 79 years old and people with medical conditions putting them at high risk of severe disease.

Additionally, residents at long-term care homes are likely at risk of severe disease and should be considered for booster doses in line with national recommendations.

However, as of July 13, 2022, the EMA stated, 'At the moment, there is no clear evidence to support giving a second booster dose to people below 60 years of age who are not at higher risk of severe disease.'

'Neither is there clear evidence to support giving early second boosters to healthcare workers or those working in long-term care homes unless they are at high risk.'

Additional COVID-19 vaccine information is posted at CoronavirusToday.com/COVID19.

Note: This EMA information from FT.com was manually curated for mobile readership.

Aug 5, 2022 • 2:21 pm CDT
by Mabel Amber

The European Commission's Health Preparedness and Response Authority (HERA) recently signed a joint procurement Framework Contract with the company HIPRA HUMAN HEALTH to supply their protein COVID-19 vaccine.

This agreement will make the HIPRA vaccine rapidly available to the participating countries as soon as this vaccine has received a positive assessment by the European Medicines Agency.

There are 14 Member States and countries participating in this joint procurement, under which they can purchase up to 250 million doses.

Commissioner for Health and Food Safety, Stella Kyriakides, stated in a media statement on August 2, 2022, "The HIPRA vaccine adds yet another option to complement our broad vaccine portfolio for our Member States and citizens."

"An increase in vaccination and boosting is essential over the coming months."

"We are working tirelessly to make sure there are vaccines available for all."

"This is our European Health Union in action – preparing ahead and being ready to act."

The joint procurement contract with HIPRA complements an already broad portfolio of vaccines secured through the EU Vaccines Strategy, including the contracts already signed with AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, BioNTech-Pfizer, Moderna, Novavax and Valneva.

Some 4.2 billion COVID-19 doses have been secured under the EU Vaccines Strategy. 

Note: This press announcement was manually curated for mobile readership.

Aug 3, 2022 • 9:13 am CDT
by Darko Stojanovic

California-based Twist Bioscience Corporation received expanded Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the SARS-CoV-2 Next-Generation Sequencing (NGS) Assay on August 2, 2022, for the qualitative detection, identification, and differentiation of SARS-CoV-2 lineages and identification of specific genomic mutations.

This expanded FDA authorization builds on the initial EUA issued in March 2021 for qualitatively detecting the SARS-CoV-2 virus.

With the expanded authorization, the reporting of the identified and differentiated SARS-CoV-2 genetic mutations and viral lineages (e.g., Delta, Omicron) to clinicians is now authorized.

The authorization also allows for the reporting of individual mutations in patient samples.

"We developed this assay in the early days of the pandemic and, while useful for detecting the presence or absence of the virus, the true value lies in receiving a comprehensive sequencing report with all identified mutations that are now available under the expanded EUA," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience, in a press release.

"We believe this assay will continue to be critical to monitor the sequence evolution of SARS-CoV-2 and is another example of our commitment to provide tools to fight the pandemic, even when it becomes endemic."

New mutations in the SARS-CoV-2 virus continue to accumulate and circulate the world, creating genetic variants of concern that may alter transmissibility or vaccine efficacy.

'The virus will continue to evolve, and we expect this capture-based assay to serve as an important new tool for viral identification, sequencing, and surveillance.'

'With this expanded EUA, we anticipate that these data will, for the first time, now enable the appropriate treatment of COVID-19,' stated the company.

Note: This press release was manually curated for mobile readers.

Aug 1, 2022 • 11:40 am CDT
Image by Tumisu

France-based Valneva SE today confirmed the signing of the amendment to its Advance Purchase Agreement (APA) with the European Commission (EC). Under this amendment, the EC Member States’ purchases of VLA2001, Valneva’s inactivated whole-virus COVID-19 vaccine, consist of 1.25 million doses in 2022.

VLA2001 is the only whole virus, inactivated, adjuvanted COVID-19 vaccine that has received marketing authorization in Europe.

The APA includes an option to purchase an equivalent quantity later this year for delivery in 2022.

Valneva stated in a media release on August 1, 2022, it expects to deliver the first vaccine doses to participating Germany, Austria, Denmark, Finland, and Bulgaria in the coming weeks.

In Europe, the European Medicines Agency has authorized six COVID-19 vaccines and is reviewing four other vaccines.

Regarding overall vaccinations, the European Centre for Disease Prevention and Control reported on July 21, 2022, that about 73% of adult Europeans had completed their primary vaccination course, while about 5.1% have been fully 'boosted' with a fourth dose.

Note: Valneva's press statement was manually curated for mobile readership.

Jul 27, 2022 • 5:56 pm CDT
from Pixabay

North Carolina-based  Brii Biosciences Limited announced today new live virus data confirming the amubarvimab/romlusevimab combination, a long-acting COVID-19 monoclonal antibody (mAb) therapy, retains neutralizing activity against the Omicron BA.4/5 and BA.2.12.1 SARS-CoV-2 subvariants.

Data from the live virus neutralization assay performed at a University of Maryland lab was certified by the U.S. NIH and NIAID and predicted that total serum concentrations of the amubarvimab/romlusevimab combination would remain greater than 170 times the level required for greater than 90% neutralization (Neut99: 0.94 μg/mL) against the live virus, 14 days post-dose. 

"As the COVID-19 pandemic continues to surge with evolving variants, these data further validate the durability and longevity of our long-acting amubarvimab/romlusevimab combination treatment and reinforce its position as a leading investigational monoclonal antibody therapy with the potential to retain activity against the most dominating strains that are circulating worldwide," commented David Margolis, M.D., MPH, Vice President and Head of Infectious Diseases Therapy Area at Brii Bio, in a press release issued on July 27, 2022.

"We're at a critical moment in the pandemic in which the new Omicron subvariants are more contagious, resulting in a sustained urgency for safe and effective treatment options."

"We look forward to continuing our discussions with global regulatory bodies as we work to advance this innovative combination therapy for COVID-19 patients in need around the world."

On December 8, 2021, the National Medical Products Administration of China approved this mAbs.

Currently, the U.S. FDA continues its evaluations.

Additional mAbs news is posted at this link.

Note: This announcement was manually curated for mobile readership.

Jul 27, 2022 • 1:46 pm CDT
from Pixabay

Florida-based Veru Inc. today announced that the European Medicines Agency's (EMA) Emergency Task Force (ETF) had informed the Company that it has initiated the review of sabizabulin for the treatment of hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome (ARDS).

Sabizabulin is an oral, novel microtubule disruptor with dual antiviral and anti-inflammatory activity in preclinical models.

On July 27, 2022, the Company stated, "The review will look at all available data, including data from a study involving hospitalized patients with moderate-to-severe COVID-19 who are at high risk of ARDS and death.

"The results of this phase 3 study would indicate that sabizabulin treatment reduces the number of deaths in these patients compared with placebo."

The NEJM published this study on July 6, 2022: Oral Sabizabulin for High-Risk, Hospitalized Adults with Covid-19: Interim Analysis.

Sabizabulin treatment resulted in a 24.9% absolute reduction in deaths compared with placebo in hospitalized patients with moderate to severe Covid-19 at high risk for ARDS and death, with a lower incidence of adverse and serious adverse events compared with placebo. 

Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru, commented in a press release, "This new emergency regulatory pathway may allow the availability of sabizabulin to EU member states before sabizabulin is approved by EMA."

"Separately, we were also informed yesterday that the sabizabulin product is eligible for submission (Article 18) of an application for a centralized marketing authorization."

"COVID-19 infections are sharply rising in Europe. Unfortunately, the death rate in hospitalized patients with moderate to severe COVID-19 at risk for ARDS remains unacceptably high with the current standard of c"re," added Dr. Stein"r.

"By reducing deaths in hospitalized COVID-19 patients, sabizabulin has great potential to play a critical role in the battle against COVID-19 in the"EU."

Additional COVID-19 treatment news is posted at CoronavirusToday.com/Antivirals.

Note: Ths Company's announcement was manually curated for mobile readers.

Jul 21, 2022 • 7:49 am CDT
by Bruno

A new Correspondence published in peer-review The New England Journal of Medicine examined the neutralizing ability of U.S. FDA-approved monoclonal antibodies, individually and in combination, against recent SARS-CoV-2 Omicron variants.

As of July 20, 2022, this data indicates that bebtelovimab is effective against BA.2.12.1, BA.4, and BA.5.

However, in clinical use, these variants may be less susceptible to combination therapy with casirivimab and imdevimab and with Evusheld (tixagevimab and cilgavimab).

In addition, sotrovimab may not provide effective treatment against BA.2.12.1, BA.4, or BA.5.

'Our findings show that the selection of monoclonal antibodies to treat patients infected with omicron variants should be carefully considered.'

'The main limitation of our study is the lack of clinical data on the efficacy of these monoclonal antibodies (mAbs),' concluded these researchers.

Non-industry grants supported this research, and the research team did not disclose conflicts of interest.

On July 1, 2022, the FDA stated, 'Nonclinical data and pharmacokinetic modeling suggest that activity against the currently circulating SARS-CoV-2 variants and subvariants may be retained for six months at drug concentrations achieved following an Evusheld dose of 300 mg of tixagevimab and 300 mg cilgavimab.'

Since September 24, 2021, the U.S. government has distributed about 5.9 million mAbs.

 Anti-SARS-CoV-2 monoclonal antibody breaking news is posted at CoronavirusToday.com/Antibodies.

Note: This information was condensed and curated for mobile readers.

Jul 21, 2022 • 7:15 am CDT
from Pixabay

A recent analysis of reports from more than 35,000 women offers a comprehensive assessment of menstrual changes experienced by pre- and post-menopausal females in the first two weeks after receiving the COVID-19 vaccine.

Published in the journal Science Advances on July 15, 2022, the study found that 42% of women with regular menstrual cycles bled more heavily than usual, while 44% reported no change after vaccination.

Among respondents, 66% of post-menopausal women reported breakthrough bleeding.

These researchers found that increased/breakthrough bleeding was significantly associated with age, systemic vaccine side effects (fever and/or fatigue), history of pregnancy or birth, and ethnicity.

Generally, changes to menstrual bleeding are not uncommon or dangerous, yet attention to these experiences is necessary to build trust in medicine, stated these researchers.

“Menstruating and formerly menstruating women began sharing that they experienced unexpected bleeding after being administered a COVID-19 vaccine in early 2021,” wrote the scientists who led the study.

Because vaccine trials typically do not ask about menstrual cycles or bleeding, this side effect was largely ignored or dismissed.

“We focused our analysis on those who regularly menstruate and those who do not currently menstruate but have in the past,” commented Kathryn Clancy, a professor of anthropology at the University of Illinois Urbana-Champaign, in a related press release.

“The latter group included post-menopausal individuals and those on hormonal therapies that suppress menstruation, for whom bleeding is especially surprising.”

Because the study relied on self-reported experiences logged more than 14 days after vaccination, it cannot establish causality or be seen as predictive of people in the general population.

But it can point to potential associations between a person’s reproductive history, hormonal status, demographics, and changes in menstruation following COVID-19 vaccination.

For example, the analysis revealed that respondents who had experienced a pregnancy were most likely to report heavier bleeding after vaccination, with a slight increase among those who had not given birth.

Most non-menstruating premenopausal respondents on hormonal treatment experienced breakthrough bleeding after receiving the vaccine.

More than 70% of respondents using long-acting reversible contraception and 38.5% of those undergoing gender-affirming hormone treatments reported this side effect.

“Unexpected breakthrough bleeding is one of the early signs of some cancers in post-menopausal people and in those who use gender-affirming hormones, so experiencing it can make people worry and require expensive and invasive cancer-screening procedures,” said Katharine Lee, an anthropology professor at Tulane University.

“Menstruation is a normal process that responds to all kinds of immune and energetic stressors. People notice changes to their bleeding patterns, yet we don’t tend to talk about it publicly.”

The Beckman Institute, the CSBS, and the Interdisciplinary Health Sciences Institute at Illinois supported this research, as did the National Institutes of Health, the Foundation for Barnes-Jewish Hospital, and the Siteman Cancer Center in St. Louis, MO.

Note: This study and press release were manually curated for mobile readers.

Jul 20, 2022 • 12:32 pm CDT
Image by Tumisu

France-based Valneva SE today announces that the European Commission (EC) has approved an amendment to the Advance Purchase Agreement (APA) for its inactivated whole-virus COVID-19 vaccine, VLA2001.

Under this amendment, the Member States' purchases will consist of 1.25 million doses of VLA2001 in 2022, with the option to purchase an equivalent quantity for delivery in late 2022.

The first vaccine doses are expected to be delivered to participating EU Member States (Germany, Austria, Denmark, Finland, and Bulgaria) in the coming weeks.

Thomas Lingelbach, CEO of Valneva, commented in a press release issued on July 20, 2022, "We welcome the fact that the EC has decided not to terminate the APA, although we feel the order volume does not reflect the interest we see from European citizens."

"Despite this, we have decided to enter into this amendment to make our vaccine available to the Europeans who have been waiting for it."

"While the pandemic had been declining, the latest COVID-19 wave in Europe underlines the need for alternative vaccines."

About "15% of European adults are not yet vaccinated, and we continue to receive messages from Europeans who are awaiting a more traditional vaccine technology."

"Recent market studies conducted in several EU member states suggest that making our inactivated vaccine available in Europe could increase vaccine uptake and have a meaningful impact on public health."

VLA2001 is the only whole virus, inactivated, adjuvanted COVID-19 vaccine, which has received marketing authorization in Europe for primary vaccinations in people from 18 to 50 years of age.

It is produced on Valneva's established Vero-cell platform, leveraging the manufacturing technology for Valneva's licensed Japanese encephalitis vaccine, IXIARO®

The vaccine was also granted conditional marketing authorization in the United Kingdom and emergency use authorization in the United Arab Emirates and the Kingdom of Bahrain.

Note: The company's press release was manually curated for mobile readers.

Jul 6, 2022 • 3:13 pm CDT
U.S. NIH

 The peer-review journal Brain published the findings of a new study that focused on the underlying mechanisms by which the SARS-CoV-2 virus leads to acute and long-term neurological manifestations.

This National Institutes of Health study announced on July 5, 2022, describes the immune response triggered by COVID-19 infection that damages the brain's blood vessels and may lead to short- and long-term neurological symptoms.

In this brain autopsy study, these researchers characterized the vascular pathology, neuroinflammatory changes, and cellular and humoral immune responses by immunohistochemistry.

All study participants were found to have multifocal vascular damage as determined by leakage of serum proteins into the brain parenchyma.

'Injury to the microvasculature by immune complexes with complement activation is the key central event that results in the breakdown of the blood-brain barrier, microthromboses, perivascular inflammation, and neuronal injury.'

"Patients often develop neurological complications with COVID-19, but the underlying pathophysiological process is not well understood," commented Avindra Nath, M.D., clinical director at NINDS and the senior author of the study in an NIH press release.

"We had previously shown blood vessel damage and inflammation in patients' brains at autopsy, but we didn't understand the cause of the damage."

"I think in this paper, we've gained important insight into the cascade of events."

This was accompanied by widespread endothelial cell activation.

Platelet aggregates and microthrombi adhered to the endothelial cells along vascular lumina.

Immune complexes activating the classical complement pathway were found on the endothelial cells and platelets.

Perivascular infiltrates consisted of predominantly macrophages and some CD8+ T cells.

Only rare CD4+ T cells and CD20+ B cells were present.

Astrogliosis was also prominent in the perivascular regions, and microglial nodules were predominant in the hindbrain, which was associated with focal neuronal loss and neuronophagia.

Antibody-mediated cytotoxicity directed against the endothelial cells is the most likely event leading to vascular leakage, platelet aggregation, neuroinflammation, and neuronal injury.

Therapeutic modalities directed against immune complexes should be considered.

The study builds on their previous research, which found evidence of brain damage caused by thinning and leaky blood vessels.

However, they suspected the damage may have been due to the body's natural inflammatory response to the coronavirus.

Importantly, these studies suggest that therapeutic approaches targeted against the development of immune complexes should be considered.

Note: This NIH announcement was manually edited for mobile readership.

Jul 6, 2022 • 2:32 pm CDT
U.S. FDA

The U.S. Food and Drug Administration (FDA) announced today it revised the oral COVID-19 treatment Paxlovid™ previous authorization to empower state-licensed pharmacists to prescribe the pill to eligible patients, subject to defined limitations.

The FDA authorizes Paxlovid to treat mild-to-moderate COVID-19 in most adults and pediatric patients.

Patrizia Cavazzoni, M.D., director for the FDA's Center for Drug Evaluation and Research, commented in a media statement issued on July 6, 2022, "Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19."

Paxlovid may not be an appropriate therapeutic option based on the current Fact Sheet for Healthcare Providers or due to potential drug interactions for which recommended monitoring would not be feasible.

Patients who have tested positive for COVID-19 and are seeking to determine their eligibility for receiving Paxlovid at locations where prescribing by state-licensed pharmacists is available should bring the following information to ensure that the state-licensed pharmacist has sufficient information to determine their eligibility to receive Paxlovid:

  • Electronic or printed health records less than 12 months old, including the most recent reports of laboratory blood work for the state-licensed pharmacist to review for kidney or liver problems. State-licensed pharmacists could also receive this information through a consult with the patient's health care provider.
  • A list of all medications they are taking, including over-the-counter medicines, so that the state-licensed pharmacist can screen for drugs with potentially serious interactions with Paxlovid.

Under the limitations outlined in the authorization, the state-licensed pharmacist should refer patients for clinical evaluation with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs if any of the following apply:

  • Sufficient information is not available to assess renal and hepatic function.
  • Sufficient information is not available to assess for a potential drug interaction.
  • Modification of other medications is needed due to a potential drug interaction.

Since December 2021, the U.S. government has distributed about 3,963,802 Paxlovid treatments in the USA.

Additional COVID-19 treatment news is posted at CoronavirusToday.

Note: The FDA announcement was manually curated for mobile readership.