The latest news updates on COVID-19 and CDC guidelines for myeloma patients and the moderately and severely immunocompromised. 

 

September 3, 2024

FDA-Approved and Authorized COVID-19 Vaccines for 2024-2025

On Tuesday, September 3, The U.S. Food and Drug Administration (FDA) released an announcement regarding the latest approved and authorized COVID-19 vaccines for 2024-2025.

On August 22, the FDA approved and authorized updated mRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna) “to better protect against currently circulating variants.”

In a separate news release, the FDA announced that it has granted emergency use authorization of the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) on August 30. 

According to the FDA news release, “specifically, FDA has authorized the following for emergency use:

• Moderna COVID-19 Vaccine (2024-2025 Formula) for individuals 6 months through 11 years of age
• Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) for individuals 12 years of age and older
• Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) for individuals 6 months through 11 years of age

The following COVID-19 vaccines are approved by FDA:

• Comirnaty (2024-2025 Formula)
• Spikevax (2024-2025 Formula)

Ingredients in COVID-19 vaccines authorized for emergency use are included in the Fact Sheets for Healthcare Providers and also the Fact Sheet for Recipients and Caregivers under the question "What are the ingredients in this vaccine?"

• Moderna COVID-19 Vaccine Fact Sheets  
• Novavax COVID-19 Vaccine, Adjuvanted Fact Sheets
• Pfizer-BioNTech COVID-19 Vaccine Fact Sheets

Ingredients in FDA-approved COVID-19 vaccines are included in the Prescribing Information for healthcare providers and in the Information for Recipients and Caregivers for vaccine recipients under the question, “What are the ingredients in this vaccine?” 

• Comirnaty (COVID-19 vaccine, mRNA) – see the package insert
• Spikevax (COVID-19 vaccine, mRNA) – see the package insert and patient package insert

 

Meanwhile, the CDC has updated its vaccination schedule pages for the approved 2024-2025 Pfizer-BioNTech and Moderna COVID-19 vaccines. Vaccination schedule and dosage for the updated Novavax COVID-19 vaccine are still unavailable, as of press time. Check back on the CDC website for updates.
 

August 19, 2024

CDC Says KP.3.1.1 is Current Predominant COVID-19 Variant in the U.S.

On Monday, August 19, the U.S. Centers for Disease and Prevention (CDC) reported that Omicron variant KP.3.1.1 “is now the predominant SARS-CoV-2 variant circulating in the United States” and has “overtaken its parent lineage KP.3 and previous KP.2 variants.”

The CDC also added that KP.3.1.1 “is the only major variant increasing in proportion nationally.”

According to CDC, KP.3.1.1 “is predicted to account for between 31 to 43 percent of COVID-19 clinical specimens” for the two-week period ending on August 17. Previously, for the two-week period ending on August 3, this variant accounted between 20 to 26 percent.

Markers of COVID-19 activity have indicated the spike in dominance of KP.3.1.1 which include test positivity, emergency department visits, and hospitalizations among adults aged 65 and older, and among children aged 2 years and younger.

The CDC is closely tracking variants of COVID-19 and still strongly recommends that all people ages 6 months and older get vaccinated to protect against severe illness.

However, the CDC points out that the SARS-CoV-2 virus continues to evolve, “with mutations in its genetic code accumulating over time. Some variants emerge and disappear, while others will emerge and continue to spread and may replace previous variants.”

Currently, the updated 2024-2025 COVID vaccine is still awaiting authorization from the U.S. Food and Drug Administration (FDA). Once approved, the CDC recommends getting the updated shot to fight against serious disease during the fall and winter months.

In the meantime, those who have never been vaccinated or are eligible for another dose (especially those aged 65 and above or who have weakened immune systems) are strongly advised to get vaccinated with the available 2023-2024 COVID-19 vaccine.

“People considering getting a 2023-2024 vaccine this year should talk with their healthcare provider to determine if this would delay their ability to get the updated 2024-2025 vaccine. For people ages 65 years and older and people with weakened immune systems, a several-month gap between vaccine doses may be recommended. CDC does not expect any major changes to this recommendation for the time between a 2023-2024 COVID-19 vaccine and a 2024-2025 COVID-19 vaccine but is awaiting guidance from the FDA. CDC has recommended the updated 2024–2025 COVID-19 vaccines, once authorized or approved by FDA, to protect against severe disease this fall and winter,” states the CDC.

Staying up to date with COVID-19 vaccines is crucial in protecting individuals from severe illness, hospitalization, and death from COVID-19.

‘Very High’ Wastewater Levels of Viral Activity Across the U.S.

A report from USA Today on August 19 stated that “the U.S. is experiencing its largest wave in COVID-19 cases since January.

“Data collected late last week by the CDC showed that 32 states have reported ‘very high’ levels of wastewater viral activity nationwide,” with “Western states having the most reported cases, followed by the South,” said USA Today.

Possible Symptoms of COVID-19

With the onset of FLiRT variants (KP.3, KP.3.1.1. and KP.2) since early spring, these variants have become “the fastest-growing omicron subvariants circulating in all U.S. regions.”
However, symptoms from the FLiRT variants have been “typically milder” as compared to past variants and may include “fever, coughing, exhaustion and loss of smell or taste,” according to Johns Hopkins University.

The CDC states that symptoms may range from mild to severe, which may occur between 2-14 days after exposure to the virus.

 

July 30, 2024

U.S. COVID-19 Cases on the Rise, Says CDC Wastewater Data

According to the latest wastewater data from the U.S. Centers for Disease and Prevention (CDC), “Nationally, the wastewater viral level activity for COVID-19 is currently HIGH,” with the West Coast having “the highest wastewater viral activity level.” 

On Monday, July 29, the Los Angeles Times reported that federal data is showing a surge in coronavirus levels in California’s wastewater that has not been seen in summertime since 2022—“indicating a wide and worsening spread of COVID.” 

The latest surge has been attributed to the spread of highly contagious FLiRT variants: “a collection of highly transmissible sibling strains that have out-muscled last winter’s dominant strain, JN.1,” said the L.A. Times.

On Friday, the CDC reported that coronavirus levels in wastewater have been “very high” in California for three consecutive weeks, adding that 37 states and the District of Columbia either have “high” or “very high” wastewater coronavirus levels.

The most recent 7-day period data (which ended in July 20) indicated a 93 percent peak in coronavirus levels in California wastewater from the summer of 2022.

“There are indications that this summer’s COVID-19 wave might have some staying power, with coronavirus levels in California wastewater being ‘high’ or ‘very high’ for 7 straight weeks,” further reported the L.A. Times.

According to Kaiser Permanente  Southern California Regional Chief of Infectious Disease  Dr. Elizabeth Hudson, there has been “a definite surge” seen in doctor’s office and clinics among those seeking outpatient treatment. However, hospitalization rates remain low.

Hudson is urging people with respiratory symptoms to take a COVID test: “ If you have cough-and-cold symptoms, at this point, living in Los Angeles, you should really think that they are COVID until proven otherwise.”

Overall, COVID deaths and hospitalizations remain lower compared to last summer’s, but the risk of infection is still highest among  individuals who are elderly and immunocompromised.

Infectious disease expert in UC San Francisco, Dr. Peter Chin-Hong suggests that individuals who are at higher risk and are not up to date with their COVID vaccine should get vaccinated sooner than later.

“It’s not showing any signs that it’s going down.” It’s a good idea for those who are older or immune-compromised to still get it right now. Because by now, I would have thought that COVID would be plateauing and going down, but it doesn’t seem that way — probably, because the rest of the country has caught up with states such as California,” said Dr. Ching-Hong.

For the latest information on COVID-19 vaccines for moderately to severely immunocompromised people, visit the CDC website. 
 
 

March 5, 2024

U.S. Government’s Free COVID-19 Test Program to be Suspended on March 8

On Tuesday, March 5, CNN reported that the U.S government will be suspending its FREE COVID-19 test program by Friday, March 8—an announcement made by the Administration for Strategic Preparedness and Response (ASPR), “an operating division of the U.S. Department of Health and Human Services.”

The program’s suspension came a few days after the CDC updated its recommendations via a streamlined Respiratory Virus Guidance on March 1. 

“The decision to suspend the program’s sixth run comes amid falling COVID-19 cases as the nation’s respiratory virus season winds down,” reported CNN.

However, ASPR also stated that “it reserves the right to reopen the testing program if needed.”

“ASPR has delivered over 1.8 billion free COVID-19 tests to the American people through COVIDTests.gov and direct distribution pathways and will continue distributing millions of tests per week to long-term care facilities, food banks, health centers, and schools,” an ASPR spokesperson told CNN.

According to ASPR, all orders placed before the deadline will still be fulfilled. You may place your final orders via USPS.com or through COVID.gov. 

“Each order includes (4) individual rapid antigen COVID-19 tests, including extended shelf life and updated expiration dates. Orders will ship FREE,” states USPS in its website.

“Residents who haven’t placed an order since then can now place two, which will provide eight tests in total, according to the US Postal Service. Each order includes four rapid antigen COVID-19 tests,” according to CNN.

 

March 1, 2024

CDC Updates and Streamlines Recommendations for Respiratory Virus Guidance

On Friday, March 1, the Centers for Disease Control and Prevention (CDC) released updated recommendations through a Respiratory Virus Guidance “for how people can protect themselves and their communities from respiratory viruses, including COVID-19.”

“The new guidance brings a unified approach to addressing risks from a range of common respiratory viral illnesses, such as COVID-19, flu, and RSV, which can cause significant health impacts and strain on hospitals and health care workers. CDC is making updates to the recommendations now because the U.S. is seeing far fewer hospitalizations and deaths associated with COVID-19 and because we have more tools than ever to combat flu, COVID, and RSV,” said CDC.

According to CDC Director Dr. Mandy Cohen, this announcement “reflects the progress we have made in protecting against severe illness from COVID-19. However, we still must use the commonsense solutions we know work to protect ourselves and others from serious illness from respiratory viruses—this includes vaccination, treatment, and staying home when we get sick.”

As part of the guidance, CDC provides active recommendations on core prevention steps and strategies:

• Staying up to date with vaccination to protect people against serious illness, hospitalization, and death. This includes flu, COVID-19, and RSV if eligible.
• Practicing good hygiene by covering coughs and sneezes, washing or sanitizing hands often, and cleaning frequently touched surfaces.
• Taking steps for cleaner air, such as bringing in more fresh outside air, purifying indoor air, or gathering outdoors.

The CDC also made updates to its isolation guidelines:

“When people get sick with a respiratory virus, the updated guidance recommends that they stay home and away from others. For people with COVID-19 and influenza, treatment is available and can lessen symptoms and lower the risk of severe illness. The recommendations suggest returning to normal activities when, for at least 24 hours, symptoms are improving overall, and if a fever was present, it has been gone without use of a fever-reducing medication.”

“Once people resume normal activities, they are encouraged to take additional prevention strategies for the next 5 days to curb disease spread, such as taking more steps for cleaner air, enhancing hygiene practices, wearing a well-fitting mask, keeping a distance from others, and/or getting tested for respiratory viruses. Enhanced precautions are especially important to protect those most at risk for severe illness, including those over 65 and people with weakened immune systems.”

The CDC’s updated guidance highlights how circumstances around COVID-19 have changed and that “while [COVID-19] remains a threat, it is far less likely to cause severe illness because of widespread immunity and improved tools to prevent and treat the disease. Importantly, states and countries that have already adjusted recommended isolation times have not seen increased hospitalizations or deaths related to COVID-19.”

By “adopting a unified approach to limiting disease spread,” the CDC streamlined its recommendations and made them “easier to follow and thus, more likely to be adopted. It does not rely on individuals to test for illness, a practice that data indicates is uneven.”

“The bottom line is that when people follow these actionable recommendations to avoid getting sick, and to protect themselves and others if they do get sick, it will help limit the spread of respiratory viruses, and that will mean fewer people who experience severe illness. That includes taking enhanced precautions that can help protect people who are at higher risk for getting seriously ill,” said National Center for Immunization and Respiratory Diseases Director Dr. Demetre Daskalakis.

Additionally, “the updated guidance also includes specific sections with additional considerations for people who are at higher risk of severe illness from respiratory viruses, including people who are immunocompromised, people with disabilities, people who are or were recently pregnant, young children, and older adults,” said CDC.

While the CDC has streamlined its recommendations, respiratory viruses “remain a public health threat.”

“The CDC will continue to focus efforts on ensuring the public has the information and tools to lower their risk or respiratory illness by protecting themselves, families, and communities.”

The CDC clarified that “this updated guidance is intended for community settings. There are no changes to respiratory virus guidance for healthcare settings.”

 

January 26, 2024

How to Avail of Free COVID-19 Treatments 

On Monday, January 8, AARP updated its article, “Are COVID-19 Treatments Still Free?” to provide helpful information on how to cover drug costs for COVID-19, now that the federal government is “no longer footing the bill for everyone.”

Universal access ended to free COVID-19 treatments expired on November 1, 2023 “when the medications transitioned from a public to a private market,” according to AARP.

To cover the cost of these treatments (including Paxlovid), people had to rely on “some combination of private insurance, public insurance, and assistance programs run by drugmakers,” AARP further added.

The good news is those who are eligible can still avail of FREE COVID-19 treatments through the following:

Medicare, Medicaid & Other Government Healthcare Programs: Paxlovid

For those with Medicare and Medicaid, Paxlovid will continue to be free this year through a government patient assistance program currently being operated by Pfizer.
 
If you have a prescription for Paxlovid and are on Medicare or Medicaid, you can enroll in the assistance program at paxlovid.iassist.com or by calling 1 (877) 219-7225. Patients, caregivers, health care providers, or pharmacists at the point of care can enroll in the program, which typically takes only about five minutes.

“The enrollment form will ask for the basics — name, date of birth, address, phone number and so on. You will also need to enter prescriber information and confirm your insurance status, so if someone else is doing the enrollment for you, be sure they have this information. After enrolling, the patient will receive an electronic voucher that can be exchanged for a free course of Paxlovid at participating pharmacies,” said AARP.

Those enrolled in the program will be covered through December 31, 2024, and “will be able to receive more than one prescribed treatment course of Paxlovid throughout 2024.”

According to Pfizer, there are approximately 55,000 pharmacies (including CVS, Walgreens, Walmart, Kroger, Costco, and more) participating in this government-supported patience assistance program with more expected to join. 

Medicare Part D

Additionally, those with Medicare Part D “can choose to use their prescription drug plans to acquire oral antiviral COVID-19 treatments,” with out-of-pocket costs varying by plan. 
 
The Centers for Medicare & Medicaid Services (CMS) is encouraging Part D sponsors “to conduct an expedited review of oral antivirals for COVID-19 released commercially on the market and add at least one oral antiviral for COVID-19 that meets the definition of a Part D drug to their formulary on a preferred or $0 cost-sharing tier, as available in the plan benefit structure.” 
 
If you are a Part D enrollee and are having trouble obtaining Paxlovid coverage, the U.S. Department of Health and Human Services (HHS) advises you to contact their plan or to call 1-800-MEDICARE for assistance.

 
Indian Health Service, Department of Veteran Affairs, and Department of Defense

According to HHS, if you are getting healthcare through the Indian Health Service, Department of Veteran Affairs, or the Department of Defense, you are eligible “to access a free supply of Paxlovid stockpiled by the federal government.”

 

Other COVID-19 Antiviral Treatments & Assistance Programs

Veklury via Medicare Part B 

Veklury (remdesivir) is a COVID-19 antiviral treatment that is only administered through an IV in a medical facility. It is covered by Medicare Part B. For those with commercial insurance, coverage and out-of-pocket costs for Veklury will vary by plan.
 

Lagevrio and the Merck Patient Assistance Program

Lagevrio is another COVID-19 antiviral treatment that is currently available under an FDA Emergency Use Authorization (EUA). Lagevrio is a treatment option for those who are unable to take Paxlovid or Veklury (remdesivir).
 
However, according to Lagevrio drugmaker Merck, there is currently no government program in place for this COVID-19 antiviral treatment. 
 
Merck is offering a patient assistance program for “eligible patients who, without assistance, could not otherwise afford the product.”  Eligibility determination for the program takes about 10-20 minutes. For more information, visit merckhelps.com or call 1 (800)727-5400.

For Those with Private Insurance

Those covered by private insurance may incur out-of-pocket costs for COVID-19 antiviral treatments. 
 
Paxlovid and Lagevrio are “subject to the regular cost-sharing policies of your health plan,” says KFF Senior Vice President and Director of the Global Health & HIV Policy Program Jennifer Kates.
 
According to HHS, “federal law does not require commercial plans to cover all possible COVID-19 treatments or put any limits on patient cost-sharing for any commercial plans if the treatments are covered.”
 
Currently, Paxlovid costs $1,390 for a five-day treatment course, as priced by Pfizer. 
 
If your private insurance does not cover Paxlovid or if the out-of-pocket cost is too high, you may be eligible for assistance through Pfizer’s copay program. 
 
The enrollment process is similar to Pfizer’s government-backed patient assistance program. Patients who enroll in this copay program may more than one prescribed treatment course of Paxlovid throughout 2024.
 
Visit paxlovid.iassist.com or call 1(877)219-7225 to enroll in the copay program. 
 
In an October announcement, the HHS stated that it expects commercial coverage for Lagevrio as well. Currently, Lagevrio is priced at $950 for a treatment course.
 

If You Are Uninsured or Underinsured

According to an October 2023 HHS news release, Paxlovid will remain free for people with no health insurance until 2028. Beginning 2025 until 2028, Paxlovid will be free for those who are underinsured. 
 
However, you will need to enroll in the patient assistance program to avail of this benefit. For more information, visit paxlovid.iassist.com or call 1(877)219-7225.
 
Merck’s patient assistance program can also help eligible individuals who are unable to afford the full cost of Lagevrio. For more information, visit merckhelps.com or call 1(800) 727-5400.
 

 

October 3, 2023

FDA Authorizes Updated Novavax COVID-19 Vaccine for Emergency Use on People Ages 12 and Older

On Tuesday, October 3, the U.S. Food and Drug Administration (FDA) authorized the updated 2023-2024 Novavax COVID-19 Vaccine, Adjuvanted for emergency use (EUA)  on individuals 12 years or older.

“The Novavax COVID-19 Vaccine, Adjuvanted, a monovalent vaccine, has been updated to include the spike protein from the SARS-CoV-2 Omicron variant lineage XBB.1.5 (2023-2024 formula). The Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent) is no longer authorized for use in the United States,” states the FDA press release. 

According to the FDA, the updated Novavax COVID-19 vaccine is authorized for emergency use on people ages 12 and older as follows:

1. Individuals previously vaccinated with any COVID-19 vaccine: one dose of Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) is administered at least 2 months after receipt of the last previous dose of an original monovalent (Original) or bivalent (Original and Omicron BA.4/BA.5) COVID-19 vaccine.
2. Individuals not previously vaccinated with any COVID-19 vaccine: two doses of Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) are administered three weeks apart.
3. Immunocompromised individuals: an additional dose of Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) may be administered at least 2 months following the last dose of a COVID-19 vaccine (2023-2024 Formula).  
4. Additional doses of Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances. The timing of the additional doses may be based on the individual’s clinical circumstances.

 
For more information, read the FDA press release.
 

September 14, 2023

What You Need to Know about the RSV and Flu Shots This Fall

On Thursday, September 14, the New York Times reported on the FDA and CDC approval of updated COVID-19 vaccines, as well as vaccination schedules alongside respiratory syncytial virus (RSV) and flu shots. 

According to NY Times, “the coronavirus, the flu, and RSV are all likely to send thousands of Americans to the hospital this year, but exactly when, and how severe the toll will be, is unknown. That’s in part because the restrictions in place during the pandemic altered the seasonal patterns of the viruses.”

“RSV is the least familiar of the three viruses, but increasingly it is recognized as a major respiratory threat, particularly to older adults, immunocompromised people and young children,” NY Times further reported.

RSV Vaccines Available in the U.S. 

Currently, there are two RSV vaccines available in the U.S. for adults ages 60 and older—Abrysvo (Pfizer) and Arexvy (GSK). However, “they are not universally recommended; patients may choose to get them in consultation with their doctors,” said NY Times.

The two vaccines are also not yet approved for those aged younger than 60 years.

The CDC has made a recommendation for Beyfortus, a monoclonal antibody shot against RSV for infants less than 8 months old as well as for infants 8-19 months old who are at risk for severe illness.

The FDA previously approved Abrysvo in August, for use in pregnant women who are at the last weeks of their pregnancy to help “prevent severe respiratory illness in infants up to 6 months.”

“Even those with no pre-existing conditions can become quite sick with all three of these viruses,” said Dr. Helen Chu, a physician and immunologist at the University of Washington. 

Flu Vaccine

Experts advise that anyone aged 6 months and older should at least get flu and COVID-19 shots this fall. 

Everyone aged 6 months and older should get an annual flu vaccine—it is especially important for adults ages 65 and older, children under 5 years and for those who are moderately or severely immunocompromised.

When to Get the Vaccines

To build immunity against pathogens, it’s advised to get the shots as early as possible. However, the timing for getting each will depend on your particular circumstances. 

If possible, it would be most prudent to time the shots, in order to get maximum protection out of them. COVID-19 shots are already available, so get the shot at the soonest possible time. Flu shots are advised around October as the flu season typically peaks around December. 

However, you may also get the shots at one time, if you are unable to make multiple trips to the vaccination clinic or pharmacy.

As NY Times reported, “getting the COVID and flu shots all at once does not significantly affect the protection or produce worse side effects compared with getting either one alone, according to a recent study by Israeli scientists.”
 

 

June 12, 2023

WHO/Europe Launches COVID-19 Transition Plan as International Public Health Emergency Ends

On Monday, June 12, the World Health Organization (WHO)/Europe announced that it will launch and implement its transition plan for COVID-19: “13 strategic shifts in its approach to managing COVID-19 across the 5 core subsystems of WHO’s work in emergencies.”
 
This, as the Public Health Emergency of International Concern (PHEIC) for COVID-19 comes to an end. 
 
“While the international public health emergency may have ended, the pandemic certainly has not. And as our Region seeks to emerge from this crisis, it is also faced with new health threats, at a time when our health systems face increasing workforce and other challenges,” said WHO/Europe Regional Director Dr. Hans Henri P. Kluge.
 
“Using the momentum built since 2020, now is the time to invest and sustain the gains made during the pandemic response and apply the lessons of this pandemic and other health emergencies. This is the way to increase the resilience of our health systems against future shocks,” he continued. 
 
According to the news release, the new transition plan will “provide a framework to leverage innovations and lessons from COVID-19 and other recent emergencies into the development of the next regional 5-year action to strengthen health emergency preparedness, response, and resilience in the WHO European Region, 2024-2029—what WHO Europe is calling Preparedness 2.0.”
 
WHO Regional Emergency Director for Europe Dr. Gerald Rockenschaub describes this as “a move towards a new paradigm that aims to give the Region the required capabilities and networks to rapidly detect, verify, and notify new and evolving health threats, and to effectively respond to emergencies caused by any hazard, grounded in the principles of solidarity, transparency, and accountability.”
 
WHO’s proposed global health architecture for Health Emergency Preparedness, Response and Resilience (HEPR) consists of five core components:

• collaborative surveillance, including sustaining and building laboratory capacity and using digital tools to collect and analyze COVID-19 data;
• community protection across the emergency cycle to enable and empower communities to take informed decisions to uptake measures that protect their health in emergencies;
• clinical care, ranging from training frontline health workers and strengthening the foundations for safe, scalable, and high-quality care to ensuring sustained investment in health services and emergency care systems;
• countermeasures, such as learning from and sustaining the COVID-19 vaccination roll-out as part of wider immunization efforts; and
• coordination, from hazard-specific COVID-19 and influenza pandemic response plans to integrated respiratory virus pandemic planning. 

To meet the objectives of the transition plan, Member States “need to strategically and sustainably invest in pandemic preparedness while maintaining vigilance through dual-track readiness that can respond to new health threats and ensuring the continuation and resilience of essential health services.” 

“The end of the global COVID-19 emergency is not an occasion to pack up and move on. It is a call to action to use this time wisely, to not waste the progress or the lessons of the past 3 years, but to sustain and learn from them in order to help create a better prepared and resilient European Region in the future,” warned WHO/Europe Senior Emergency Officer Dr. Catherine Smallwood.

To know more about WHO/Europe’s COVID-19 transition plan, read the full news release.
 

May 25, 2023

FDA Approves Paxlovid for Treatment of Adults at High-Risk of Progressing to Severe COVID-19

On Thursday, May 25, the U.S. Food and Drug Administration (FDA) approved the use of oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) to treat mild-to-moderate COVID-19 in adults who may be at high-risk of progressing to severe COVID-19, including hospitalization and death. 

“Paxlovid is the fourth drug—and first oral antiviral pill-approved by the FDA to treat COVID-19 in adults,” states the FDA press release.

The oral antiviral is still currently being distributed by the U.S. Department of Health and Human Services (HHS) and “will continue to be available to ensure continued access for adults, as well as treatment of eligible children ages 12-18 who are not covered by [Thursday’s] approval. Paxlovid is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis for prevention of COVID-19,” notes the FDA. 

“Today’s (May 25)approval demonstrates that Paxlovid has met the agency’s rigorous standards for safety and effectiveness, and that it remains an important treatment option for people at high risk for progression to severe COVID-19, including those with prior immunity. The FDA remains committed to working with sponsors to facilitate the development of new prevention and treatment options for COVID-19,” said FDA Center for Drug Evaluation and Research Director Patrizia Cavazzoni, MD. 

According to a press release from Pfizer: “Approval is based on the totality of scientific evidence submitted, including efficacy data from the Phase 2/3 EPIC-HR study showing an 86 percent reduction in risk of COVID-19-related hospitalization or death from any cause in patients who took Paxlovid within five days of symptom onset. Paxlovid remains available to eligible patients via prescription at no charge*” (*Other administrative fees may apply).

To learn more about Paxlovid, read the Fact Sheet for Patients, Parents, and Caregivers or the Fact Sheet for Health Providers from the FDA.
 

 

January 26, 2023

Evusheld No Longer Authorized for Emergency Use in the U.S. Until Further Notice, Says FDA

On Thursday, January 26, The U.S. Food and Drug Administration (FDA) announced through a press release that Evusheld (tixagevimab co-packaged with cilgavimab) is no longer currently authorized for emergency use (EUA) in the U.S., until further notice.

“The U.S. Food and Drug Administration today revised the Emergency Use Authorization (EUA) for Evusheld (tixagevimab co-packaged with cilgavimab) to limit its use to when the combined frequency of non-susceptible SARS-CoV-2 variants nationally is less than or equal to 90%. Based on this revision, Evusheld is not currently authorized for use in the U.S. until further notice by the Agency,” states the press release.

On January 6, the FDA released important information regarding the risk of COVID-19 because certain variants are not neutralized by Evusheld. The FDA was “closely monitoring the emergence of the XBB.1.5 subvariant, a SARS-CoV-2 Omicron variant that is currently estimated to account for 28 percent of circulating variants in the U.S.”

“Because of its similarity to variants that are not neutralized by Evusheld (e.g., XBB), FDA does not anticipate that Evusheld will neutralize XBB.1.5. This means that Evusheld may not provide protection against developing COVID-19 for individuals who received Evusheld and are later exposed to XBB.1.5,” stated the FDA.

Meanwhile, the most recent CDC Nowcast data revealed  that “these variants are projected to be responsible for more than 90 percent of current infections in the U.S. This means that Evusheld is not expected to provide protection against developing COVID-19 if exposed to those variants.”

The FDA’s action in limiting the use of Evusheld will “prevent exposing patients to possible side effects of Evusheld such as allergic reactions, which can be potentially serious, at a time when fewer than 10 percent of circulating variants in the U.S. causing infection are susceptible to the product.”

Evusheld is a laboratory-made monoclonal antibody that “mimics the immune system’s ability to fight off harmful pathogens such as viruses, like SARS-CoV-2.” However, viruses can mutate over time, thus Evusheld can no longer work against certain variants. This prompted the FDA to make changes to its authorization. 

The FDA advises that patients who become infected with SARS-CoV-2 and develop symptoms seek medical attention and start treatment for COVID-19 as needed. Currently, there are several treatments that are authorized or approved—Paxlovid, Veklury (remdesivir) and Lagevrio (molnupiravir)—to treat certain patients with mild-to-moderate COVID-19 who are at high risk for severe disease, including hospitalization or death. Healthcare providers are advised to assess whether treatments are right for their patients. 

However, the U.S. government still recommends that facilities and providers with Evusheld “retain all product in the event that SARS-CoV-2 variants which are neutralized by Evusheld become more prevalent in the U.S. in the future. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Healthcare Providers and the Letter of Authorization.”

“FDA will continue to work with ASPR, the CDC, and the National Institutes of Health on surveillance of variants that may impact the use of the therapies authorized for emergency use. We will provide further updates and consider additional action as new information becomes available. Any updates will be made available on the FDA’s website.”