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

September 22, 2022

CDC Update: Strategy for Global Response to COVID-19 (2020-2023)

On Thursday, September 22, the U.S. Centers for Disease Control and Prevention (CDC) released its Strategy for Global Response to COVID-19 for 2020-2023.

According to the CDC, the strategy “provides an overarching framework for the U.S. Centers for Disease Control and Prevention’s global response to the coronavirus (COVID-19) pandemic. The CDC strategy aligns with the U.S. Government (USG) strategy and the U.S. National Security Strategic goals to protect the American people and ensure the U.S. health security by mitigating the spread of infectious disease threats abroad, ending the pandemic, and building resilience and readiness for future pandemics. The updated CDC strategy also aligns with the U.S. COVID-19 Global Response and Recovery Framework released in September 2022. The updated U.S. framework has five main objectives.”

U.S. Government (USG) Global COVID-19 Objectives (From CDC): 

  1. Accelerate widespread and equitable access to and delivery of safe and effective COVID-19 vaccinations.
  2. Reduce morbidity and mortality from COVID-19, mitigate transmission, and strengthen health systems, including to prevent, detect, and respond to pandemic threats.
  3. Address acute needs driven by COVID-19, mitigate household shocks, and build resilience.
  4. Bolster economies and other critical systems under stress due to COVID-19 to prevent backsliding and enable recovery.
  5. Strengthen the international health security architecture to prevent, detect, and respond to pandemic threats.

Goals

The goals of CDC’s strategy for global response to COVID-19 include:

  1. Reduce transmission of SARS-CoV-2 (the virus responsible for COVID-19) and impact of COVID-19 globally;
  2. Expand scientific knowledge of SARS-CoV-2 and strengthen global public health leadership; and
  3. Improve long-term health security in low- and middle-income countries.

 

To know more about the CDC Strategy for Global Response to COVID-19 (2020-2023), visit the CDC website
 

September 21, 2022

Amid Supply Issues, Numerous Batches of Moderna Updated COVID-19 Boosters Authorized for Release by FDA 

On Wednesday, September 21, the U.S. Food and Drug Administration authorized the release of “numerous batches” of the updated Moderna COVID-19 bivalent booster “amid reports of supply problems in some areas,” as reported by CNN.

On August 31, the FDA authorized the use of Pfizer/BioNTech and Moderna updated COVID-19 boosters with the U.S. Centers for Disease Control and Prevention (CDC) quickly signing off on its recommendation for administering said updated COVID-19 boosters a few days later. The updated COVID-19 boosters were made available as early as September 2. 

However, according to CNN, “pharmacy chains have reported trouble keeping Moderna’s shots in stock.” 

According to FDA spokesman Michael Felberbaum, during the time when the FDA authorized the updated boosters, one of Moderna’s facilities was “in the middle of an inspection.”

"FDA did not include this facility as an authorized manufacturing facility for the updated COVID-19 vaccine booster at that time,” said Felberbaum. 

“The government supply of the updated Moderna COVID-19 booster is currently limited, causing appointments for the product to vary across the country,” Walgreens told CNN on Tuesday, while adding that “the updated Pfizer COVID-19 booster remains available.”

Meanwhile, Rite-Aid has “received limited supply of the Moderna COVID-19 booster and expects to receive additional supply in the coming weeks,” but has “ sufficient supply of Pfizer updated boosters in all stores,” CNN further reported.  

According to Moderna, they are “still on track to deliver 70 million doses” by the end of this year and that they “are working closely with the U.S. government to deliver significant amounts of updated, bivalent booster doses.” The company “anticipates that these availability constraints will be resolved in the coming days,” said CNN. 
 

September 14, 2022

CDC Updates: COVID-19 Vaccines and Boosters for Moderately or Severely Immunocompromised Individuals 

On Wednesday, September 14, the U.S. Centers for Disease Control and Prevention (CDC)updated its guidelines on COVID-19 vaccines and boosters for people who are moderately or severely immunocompromised to include the following: 

  • If you are moderately or severely immunocompromised (have a weakened immune system), you are at increased risk of severe COVID-19 illness and death. Additionally, your immune response to COVID-19 vaccination may not be as strong as in people who are not immunocompromised.
  • As with vaccines for other diseases, you are protected best when you stay up to date with your COVID-19 vaccines.
  • CDC recommends everyone ages 12 years and older get an updated COVID-19 booster to help restore protection that has decreased since your last vaccine, and provides improved protection against newer variants. Updated boosters, also known as bivalent boosters, target the most recent Omicron subvariants, known as BA.4 and BA.5, in addition to the original SARS-CoV-2.
  • Use CDC’s COVID-19 booster tool to learn if and when you can get boosters to stay up to date with your COVID-19 vaccines. You may also be eligible for Evusheld, a medicine given by your healthcare provider every six months to help prevent you from getting COVID-19.
  • You can self-attest to your moderately or severely immunocompromised status, which means you do not need any documentation of your status in order to receive COVID-19 vaccine or booster doses, wherever they are offered.

September 8, 2022

CDC Updates: COVID-19 Vaccines and Boosters

On Thursday, September 8, the U.S. Centers for Disease Control and Prevention (CDC)updated its guidelines on COVID-19 vaccines and boosters to include the following: 
        

CDC recommends everyone stay up to date with COVID-19 vaccination, including all primary series doses and boosters for their age group:

  • People ages 6 months through 4 years should get all COVID-19 primary series doses.
  • People ages 5 years and older should get all primary series doses, and the booster dose recommended for them by CDC, if eligible.
  • People ages 5 years to 11 years are currently recommended to get the original (monovalent) booster.
  • People ages 12 years and older are recommended to receive one updated Pfizer or Moderna (bivalent) booster. This includes people who have received all primary series doses and people who have previously received one or more original (monovalent) boosters. At this time, people aged 12 years to 17 years can only receive the updated Pfizer bivalent booster.
  • Getting a COVID-19 vaccine after you recover from COVID-19 infection provides added protection against COVID-19.
  • People who are moderately or severely immunocompromised have different recommendations for COVID-19 vaccines, including boosters.
  • COVID-19 vaccine and booster recommendations may be updated as CDC continues to monitor the latest data.

 

September 2, 2022

CDC Updates: COVID-19 Vaccines and Boosters

On Friday, September 2, the U.S. Centers for Disease Control and Prevention (CDC) updated its guidelines on COVID-19 vaccines and boosters to include the following: 

  • CDC recommends everyone stay up to date with COVID-19 vaccination, including all primary series doses and boosters for their age group:

           - Ages 6 months through 4 years should get all COVID-19 primary series doses,

           - Ages 5 years and older should get all primary series doses, and updated COVID-19 boosters if eligible.

  • Getting a COVID-19 vaccine after you recover from COVID-19 infection provides added protection against COVID-19.
  • People who are moderately or severely immunocompromised have different recommendations for COVID-19 vaccines, including boosters.
  • For people ages 12 years and older, the only authorized mRNA booster is the updated (bivalent) booster. People ages 12 years and older can no longer get the original (monovalent) mRNA booster
  • COVID-19 vaccine and booster recommendations may be updated as CDC continues to monitor the latest data.

For people who are moderately or severely compromised, the CDC has issued the following updated recommendations:

  • If you are moderately or severely immunocompromised (have a weakened immune system), you are at increased risk of severe COVID-19 illness and death. Additionally, your immune response to COVID-19 vaccination may not be as strong as in people who are not immunocompromised.
  • As with vaccines for other diseases, you are protected best when you stay up to date with your COVID-19 vaccines as described below.
  • CDC recommends everyone ages 12 years and older get an updated COVID-19 booster to help restore protection that has decreased since your last vaccine, and provides improved protection against newer variants. Updated boosters, also known as bivalent boosters, target the most recent Omicron subvariants, known as BA.4 and BA.5, in addition to the original SARS-CoV-2.
  • Use CDC’s COVID-19 booster tool to learn if and when you can get boosters to stay up to date with your COVID-19 vaccines. You may also be eligible for Evusheld, a medicine given by your healthcare provider every six months to help prevent you from getting COVID-19.
  • You can self-attest to your moderately or severely immunocompromised status, which means you do not need any documentation of your status in order to receive COVID-19 vaccine or booster doses, wherever they are offered.

For specific guidelines on vaccines and boosters for individuals who are moderately or severely immunocompromised and for each age group, please refer to our FAQ page. 

 

September 1, 2022

CDC Signs Off on Updated COVID-19 mRNA Boosters: Doses May Be Available as Early as September 2 

On Thursday evening, September 1, U.S. Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky signed off on the CDC’s recommendation to administer the updated Moderna and Pfizer-BioNTech Bivalent COVID-19 vaccines to Americans this fall, as reported by CNN. 
  

Voting 13-1 earlier in the day, the CDC’s Advisory Committee on Immunization Practices pushed through with its recommendation for the updated mRNA boosters following the FDA’s authorization for their emergency use on Wednesday, August 31.  

The sign-off by the CDC means that the boosters could be made available as early as Friday (September 2), as stated by pharmaceutical manufacturers who began shipping the new doses after the FDA issued emergency use authorization (EUA) for the updated boosters, CNN further reports. 

In a statement, CDC Director Walensky said that “the updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant. They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants. This recommendation followed a comprehensive scientific evaluation and robust scientific discussion. If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive it.”

The CDC also stated that it “expects to recommend updated COVID-19 boosters for other pediatric groups” in the coming weeks. 

According to CNN, “the updated boosters have instructions that tell our cells to make antibodies against two strains of the virus that causes COVID-19: the original strain and the BA.4 and BA.5 omicron subvariants, which share the same spike.”

Individuals who have completed all primary doses in their vaccine series are eligible to receive the updated boosters. The CDC Advisory Committee recommends that the updated mRNA boosters “be given at least two months after the last dose of any COVID-19 vaccine and up to three months after an infection,” CNN noted, adding that “the new formulations do not replace shots for the primary series.”
 

August 31, 2022

FDA Issues Emergency Use Authorization (EUA) of Updated Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines as Boosters


On Wednesday, August 31, the U.S. Food and Drug Administration (FDA) authorized the emergency use of the updated Moderna and Pfizer-BioNTech Bivalent COVID-19 vaccines for use as booster doses. 

The FDA authorized “bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. The bivalent vaccines, which we will also refer to as ‘updated boosters,’ contain two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strains of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2,” states the FDA press release.
 
The Pfizer BioNTech COVID-19 Vaccine, Bivalent, has been authorized for use as a single booster dose in individuals ages 12 and older while the Moderna COVID-19 Vaccine, Bivalent has been authorized for use as a single booster dose in individuals ages 18 and older. 
 
According to a report from CNN, “this is the first time updated COVID-19 vaccines have received emergency use authorization (EUA) in the United States.” 
 
CNN further reported that the updated Moderna and Pfizer-BioNTech booster shots can only be administered after an official recommendation is received from the U.S. Centers for Disease Control and Prevention (CDC). The CDC’s vaccine advisory group is scheduled to vote on Thursday, September 1, “on whether to support recommending the boosters for use.”
 
After a decision is made, CDC Director Rochelle P. Walensky will need to sign off on the recommendation. 
 
Once a CDC recommendation is in place, these updated boosters can be administered to both the elderly (who may have received a booster a few months ago) and to younger individuals who have been ineligible for an additional booster shot during the most recent wave of cases, CNN further notes.

Along with this latest EUA, the FDA made this important announcement:

“With today’s authorization, the FDA has also revised the EUA of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to remove the use of the monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines for booster administration for individuals 18 years of age and older and 12 years of age and older, respectively. These monovalent vaccines continue to be authorized for use for administration of a primary series for individuals 6 months of age and older as described in the letters of authorization. At this time, the Pfizer-BioNTech COVID-19 Vaccine remains authorized for administration of a single booster dose for individuals 5 through 11 years of age at least five months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine.” 

Additional information from the FDA

  • The authorized bivalent COVID-19 vaccines, or updated boosters, include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant. 
  • The BA.4 and BA.5 lineages of the omicron variant are currently causing most cases of COVID-19 in the U.S. and are predicted to circulate this fall and winter. In June, the agency’s Vaccines and Related Biological Products Advisory Committee voted overwhelmingly to include an omicron component in COVID-19 booster vaccines.
  • For each bivalent COVID-19 vaccine, the FDA based its decision on the totality of available evidence, including extensive safety and effectiveness data for each of the monovalent mRNA COVID-19 vaccines, safety and immunogenicity data obtained from a clinical study of a bivalent COVID-19 vaccine that contained mRNA from omicron variant BA.1 lineage that is similar to each of the vaccines being authorized, and nonclinical data obtained using a bivalent COVID-19 vaccine that contained mRNA of the original strain and mRNA in common between the BA.4 and BA.5 lineages of the omicron variant.
  • Based on the data supporting each of these authorizations, the bivalent COVID-19 vaccines are expected to provide increased protection against the currently circulating omicron variant. Individuals who receive a bivalent COVID-19 vaccine may experience side effects commonly reported by individuals who receive authorized or approved monovalent mRNA COVID-19 vaccines.
  • With today’s authorization, the monovalent mRNA COVID-19 vaccines are NOT authorized as booster doses for individuals 12 years of age and older.
  • The agency will work quickly to evaluate future data and submissions to support authorization of bivalent COVID-19 boosters for additional age groups as we receive them.

 
Who is eligible to receive a single booster dose and when:

  • Individuals 18 years of age and older are eligible for a single booster dose of the Moderna COVID-19 Vaccine, Bivalent if it has been at least two months since they have completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. 
  • Individuals 12 years of age and older are eligible for a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent if it has been at least two months since they have completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

For additional information, please visit the FDA’s website. 
 

August 19, 2022

FDA Issues Emergency Use Authorization (EUA) of Novavax COVID-19 Vaccine for Individuals Ages 12-17

On Friday, August 19, the U.S. Food and Drug Administration (FDA) authorized the emergency use of the Novavax COVID-19 vaccine for individuals ages 12-17 via a letter of authorization, which was later announced by Novavax. 

The FDA's letter of authorization, addressed to Novavax, Inc., stated the following:

"On August 19, 2022, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the July 13, 2022, letter in its entirety with revisions incorporated to authorize the use of Novavax COVID-19 Vaccine, Adjuvanted for individuals 12 through 17 years of age. 

The Novavax COVID‐19 Vaccine, Adjuvanted is authorized for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. The vaccine contains a recombinant spike (rS) protein, and saponin-based adjuvant, Matrix-M. The Novavax COVID-19 Vaccine, Adjuvanted is an investigational vaccine not licensed for any indication. 

For the August 19, 2022 authorization for individuals 12 years through 17 years of age, FDA reviewed safety and effectiveness data from the adolescent primary series expansion of Study 1, an ongoing phase 3 trial described above. In the primary series expansion, 2,232 individuals 12 to 17 years of age received at least one dose of the Novavax COVID-19 Vaccine, Adjuvanted (n=1,487) or saline placebo (n=745). Of participants who received two doses of the Novavax COVID-19 Vaccine, Adjuvanted in the pre-crossover period (n=1,468), 86% had a follow-up duration of at least 2 months (median = 71 days) after Dose 2. Of participants who received two doses of the Novavax COVID-19 Vaccine, Adjuvanted in the post-crossover period (n=638), 43% had a follow-up duration of at least 1 month (median = 30 days) after the last dose.

FDA’s review considered the safety and effectiveness data as they relate to the request for EUA and did not identify specific safety concerns that would preclude issuance of an EUA. Effectiveness in adolescents 12 years through 17 years of age is based on a comparison of SARS-CoV-2 neutralizing antibody titers 14 days after dose 2 in a subset of individuals in that age group to SARS-CoV-2 neutralizing antibody titers 14 days after dose 2 in a subset of adults 18 years through 25 years of age from the main adult study. Noninferior immune responses in the subset of adolescents compared to the subset of adults, as assessed by geometric mean titers and seroconversion rates were demonstrated. FDA’s analysis of available descriptive efficacy data from 1,799 participants 12 years through 17 years of age without evidence of SARS-CoV-2 infection through 6 days after the second dose and who had a median follow-up of 67 days after Dose 2 during the pre-crossover period shows that the vaccine was 78.29% effective (95% confidence interval 37.55, 92.45) in preventing PCR-confirmed symptomatic mild, moderate, or severe COVID-19 occurring at least 7 days after Dose 2. In this analysis, no cases of moderate or severe COVID-19 were reported in participants who had received the Novavax COVID-19 Vaccine, Adjuvanted or placebo. Based on these data, FDA concluded that it is reasonable to believe that the Novavax COVID‐19 Vaccine, Adjuvanted may be effective in individuals 12 through 17 years of age. Additionally, FDA determined it is reasonable to conclude, based on the totality of the scientific evidence available, that the known and potential benefits of the Novavax COVID‐19 Vaccine, Adjuvanted outweigh its known and potential risks for the prevention of COVID-19 in individuals 12 through 17 years of age."

"Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of the Novavax COVID‐19 Vaccine, Adjuvanted for the prevention of COVID-19 as described in the Scope of Authorization section of this letter (Section II) and subject to the terms of this authorization," states the letter further, signed by FDA Director of Center for Biologics Evaluation and Research Peter Marks,MD, Ph.D.

Novavax President & CEO Stanley C. Erick is hoping that more vaccine options will "help increase vaccination rates, particularly as we prepare for ongoing surges of COVID-19 with the start of fall and the back-to-school season," he said in a statement to CNBC News. 

 

August 11, 2022

CDC Streamlines COVID-19 Guidance for the Public’s Better Protection and Easier Understanding of Risks 

On Thursday, August 11, the Center for Disease Control and Prevention (CDC) streamlined its COVID-19 guidance for the public to better understand exposure risks, to know how to protect themselves and others, as well as what actions to take if they test positive or get sick with COVID-19. The updates also cover interim clinical considerations for use of COVID-19 vaccines currently approved or authorized in the U.S.

Among the new CDC guidelines are updates on exposure risksfactors that raise the risk of getting very sick from COVID-19what to do if you're exposed to COVID-19, and isolation and precautions for people with COVID-19.

“COVID-19 continues to circulate globally, however, with so many tools available to us for reducing COVID-19 severity, there is significantly less risk of severe illness, hospitalization and death compared to earlier in the pandemic,” states the CDC in its press release. 

“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. 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,” said Greta Massetti, PhD, MPH and MMWR author.

To support its streamlining efforts, the CDC will:

  • Continue to promote the importance of being up to date with vaccination to protect people against serious illness, hospitalization, and death. Protection provided by the current vaccine against symptomatic infection and transmission is less than that against severe disease and diminishes over time, especially against the currently circulating variants. For this reason, it is important to stay up to date, especially as new vaccines become available.
  • Update its guidance for people who are not up to date on COVID-19 vaccines on what to do if exposed to someone with COVID-19.  This is consistent with the existing guidance for people who are up to date on COVID-19 vaccines.
  • Recommend that instead of quarantining if you were exposed to COVID-19, you wear a high-quality mask for 10 days and get tested on day 5.
  • Reiterate that regardless of vaccination status, you should isolate from others when you have COVID-19. You should also isolate if you are sick and suspect that you have COVID-19 but do not yet have test results. If your results are positive, follow CDC’s full isolation recommendations. If your results are negative, you can end your isolation.
  • Recommend that if you test positive for COVID-19, you stay home for at least 5 days and isolate from others in your home.  You are likely most infectious during these first 5 days. Wear a high-quality mask when you must be around others at home and in public.

           ◦    If after 5 days you are fever-free for 24 hours without the use of medication, and your symptoms are improving, or you never had symptoms, you may end isolation after day 5.
           ◦    Regardless of when you end isolation, avoid being around people who are more likely to get very sick from COVID-19 until at least day 11.
           ◦    You should wear a high-quality mask through day 10.

  • Recommend that if you had moderate illness (if you experienced shortness of breath or had difficulty breathing) or severe illness (you were hospitalized) due to COVID-19 or you have a weakened immune system, you need to isolate through day 10.
  • Recommend that if you had  severe illness or have a weakened immune system, consult your doctor before ending isolation. Ending isolation without a viral test may not be an option for you. If you are unsure if your symptoms are moderate or severe or if you have a weakened immune system, talk to a healthcare provider for further guidance.
  • Clarify that after you have ended isolation, if your COVID-19 symptoms worsen, restart your isolation at day 0. Talk to a healthcare provider if you have questions about your symptoms or when to end isolation.
  • Recommend screening testing of asymptomatic people without known exposures will no longer be recommended in most community settings.
  • Emphasize that physical distance is just one component of how to protect yourself and others.  It is important to consider the risk in a particular setting, including local COVID-19 Community Levels and the important role of ventilation, when assessing the need to maintain physical distance.
  • Continue to update and inform the public of actions to take through its COVID-19 Community Levels section.
  • Continue to focus efforts on preventing severe illness and post-COVID conditions, while ensuring everyone has the information and tools that they need to lower their risk. 

“This updated guidance is intended to apply to community settings. In the coming weeks CDC will work to align stand-alone guidance documents, such as those for healthcare settings, congregate settings at higher risk of transmission, and travel, with [the August 11] update,” states the CDC. 
 

COVID-19 Updated Guidelines from the CDC

On August 11, the Center for Disease Control and Prevention (CDC) provided new updates regarding exposure risks, factors that raise the risk of getting very sick from COVID-19, what to do if you're exposed to COVID-19, and isolation and precautions for people with COVID-19.

Isolation and Precautions for People with COVID-19 

If you were exposed to COVID-19, you should start taking precautions.

This information is intended for a general audience. Healthcare professionals should see Ending Isolation and Precautions for People with COVID-19. This CDC guidance is meant to supplement—not replace—any federal, state, local, territorial, or tribal health and safety laws, rules, and regulations. If you have COVID-19, you can spread the virus to others. There are precautions you can take to prevent spreading it to others: isolation, masking, and avoiding contact with people who are at high risk of getting very sick. Isolation is used to separate people with confirmed or suspected COVID-19 from those without COVID-19. These recommendations do not change based on COVID-19 Community Levels. If you have COVID-19, also see additional information on treatments that may be available to you.

When to Isolate

Regardless of vaccination status, you should isolate from others when you have COVID-19. You should also isolate if you are sick and suspect that you have COVID-19 but do not yet have test results. If your results are positive, follow the full isolation recommendations below. If your results are negative, you can end your isolation.

If you test POSITIVE, follow these isolation recommendations: 


1. No Symptoms

  • Day 0 is the day you were tested (not the day you received a positive result)
  • Day 1 is the first full day following the day you were tested
  • If you develop symptoms within 10 days of when you were tested, restart Day 0 on the day of symptom onset

2. With Symptoms

  • Day 0 of isolation is the day of symptom onset, regardless of when you tested positive
  • Day 1 is the first full day after the day your symptoms started

Isolation

If you test positive for COVID-19, stay home for at least 5 days and isolate from others in your home. You are likely most infectious during these first 5 days.

  •         Wear a high-quality mask if you must be around others at home and in public.
  •         Do not go places where you are unable to wear a mask, including travel and public transportation settings.
  •         Stay home and separate from others as much as possible.
  •         Use a separate bathroom, if possible.
  •         Take steps to improve ventilation at home, if possible.
  •         Don’t share personal household items, like cups, towels, and utensils.
  •         Monitor your symptoms. If you have an emergency warning sign (like trouble breathing), seek emergency medical care immediately.


Ending Isolation

End isolation based on how serious your COVID-19 symptoms were.

If you had NO symptoms: You may end isolation after day 5.
If you had symptoms: You may end isolation after day 5 if:

  • You are fever-free for 24 hours (without the use of fever-reducing medication)
  • Your symptoms are improving

If you still have fever or your other symptoms have not improved, continue to isolate until they improve.

If you had moderate illness (if you experienced shortness of breath or had difficulty breathing), or severe illness (you were hospitalized) due to COVID-19, or you have a weakened immune system, you need to isolate through day 10.

If you had severe illness or have a weakened immune system, consult your doctor before ending isolation. Ending isolation without a viral test may not be an option for you.

If you are unsure if your symptoms are moderate or severe or if you have a weakened immune system, talk to a healthcare provider for further guidance.

Regardless of when you end isolation, avoid being around people who are more likely to get very sick from COVID-19 until at least day 11. 

Remember to wear a high-quality mask when indoors around others at home and in public and not go places where you are unable to wear a mask until you are able to discontinue masking.

Loss of taste and smell may persist for weeks or months after recovery and need not delay the end of isolation.


Removing Your Mask

After you have ended isolation, when you are feeling better (no fever without the use of fever-reducing medications and symptoms improving), wear your mask through day 10.

If you have access to antigen tests, you should consider using them. With two sequential negative tests 48 hours apart, you may remove your mask sooner than day 10.

Note: If your antigen test results* are positive, you may still be infectious. You should continue wearing a mask and wait at least 48 hours before taking another test. Continue taking antigen tests at least 48 hours apart until you have two sequential negative results. This may mean you need to continue wearing a mask and testing beyond day 10.

After you have ended isolation, if your COVID-19 symptoms recur or worsen, restart your isolation at day 0. Talk to a healthcare provider if you have questions about your symptoms or when to end isolation.

(*As noted in the Food and Drug Administration labeling for authorized over-the-counter antigen tests, negative test results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.)

Equity Considerations

From the CDC: People with disabilities and those from certain racial and ethnic minority groups might be more likely to get very sick and have adverse health outcomes from COVID-19 because of factors stemming from societal inequities. CDC established the COVID-19 Response Health Equity Strategy: Accelerating Progress Towards Reducing COVID-19 Disparities and Achieving Health Equity and provides additional resources to advance the vision of all people having the opportunity to attain the highest level of health possible.

For more information, please refer to the FAQs these new updates. 

 

July 29, 2022 

66 Million Doses of Moderna’s Variant-Specific COVID-19 Vaccine Booster Secured by Biden-Harris Administration for Fall-Winter 2022 


On July 29, the U.S. Department of Health and Human Services (HHS), working alongside the U.S. Department of Defense (DOD), announced that it has secured a contract agreement “to purchase 66 million doses of Moderna’s bivalent COVID-19 vaccine booster candidate for potential use in the fall and winter.” 

The announcement comes after a recommendation made by the U.S. Food and Drug Administration (FDA) in June for vaccine manufacturers to “update their existing COVID-19 vaccines to create a bivalent booster that can target BA.4 and BA.5 omicron subvariants,” the HHS press release further states.  

Apart from this recent purchase, 105 million bivalent COVID-19 vaccine booster doses from Pfizer were also purchased by the U.S. government for potential use during this year’s fall and winter months. The Pfizer and Moderna bivalent COVID-19 vaccine boosters are still awaiting FDA authorization and CDC recommendation. In the event that the FDA and CDC give their approvals, HHS will be receiving the first deliveries of the Pfizer and Moderna vaccine boosters in early fall.  

“We look forward to receiving these new variant-specific vaccines and working with state and local healthcare partners to make the vaccines available for free in communities around the country this fall,” said HHS Assistant Secretary Dawn O’Connell who leads the Administration for Strategic Preparedness and Response (ASPR). 

“Combined, the two agreements with Moderna and Pfizer would make available to the U.S. approximately 171 million bivalent vaccine booster doses for the fall and beyond, should they be authorized and recommended, which would not be enough for every single American. Both Moderna and Pfizer agreements include options for a total of 600 million doses—300 million from each company—but these options can only be exercised with additional funding from Congress,” the HHS notes.  

 

July 19, 2022

CDC Recommends Novavax COVID-19 Vaccine for Adults Ages 18 and Older

On Tuesday, July 19, The Centers for Disease Control and Prevention (CDC) cleared the two-dose Novavax COVID-19 vaccine for use as a primary vaccine series in adults ages 18 and older, according to a report from CNBC.

Unlike mRNA-based COVID-19 vaccines, the Novavax vaccine is based “on conventional technology that has been used for more than 30 years,” and provides an option for the unvaccinated, says CNBC.

“Novavax’s COVID-19 vaccine, which will be available in the coming weeks, is an important tool in the pandemic and provides a more familiar type of COVID-19 vaccine technology for adults. Having multiple types of vaccines offers more options and flexibility for the public, jurisdictions, and vaccine providers,” states the CDC’s press release.

After reviewing the Novavax COVID-19 vaccine’s safety and effectiveness at a public meeting, a unanimous vote was reached by the CDC’s committee of independent advisors with CDC Director Dr. Rochelle Walensky backing the recommendation and finalizing the authorization process for the new vaccine. 

Health and Human Services has reported that 3.2 million doses have already been secured by the Biden administration. 

Based on CDC data, 77 percent of U.S. adults are now fully vaccinated with either the Pfizer-BioNTech and Moderna COVID-19 vaccines, as well as J&J’s Janssen COVID-19 vaccine, at a much lesser extent. 

Currently, about 26 million to 37 million U.S. adults are still unvaccinated. CDC Director Dr. Walensky stated that this move will provide an option for those who are reluctant to receive mRNA-based vaccines. 

“Protein subunit vaccines package harmless proteins of the COVID-19 virus alongside another ingredient called an adjuvant that helps the immune system respond to the virus in the future. Vaccines using protein subunits have been used for more than 30 years in the United States, beginning with the first licensed hepatitis B vaccine. Other protein subunit vaccines used in the United States today include those to protect against influenza and whooping cough (acellular pertussis),” CDC further states.

According to data from clinical trials, the Novavax COVID-19 vaccine is “90 percent effective at preventing illness overall and 100 percent effective at preventing severe disease when the alpha variant of COVID was dominant. The company has not published data on the real-world effectiveness of its shots against omicron and its subvariants,” CNBC further reports. 

However, the Novavax vaccine “appears to produce a strong immune response against omicron and its subvariants,”— with immune response data against the omicron subvariant “impressing members of the U.S. Food and Drug Administration’s (FDA) vaccine committee” in June. 

A fact sheet for healthcare providers, however, notes a warning from the FDA—Novavax COVID-19 vaccine may carry a risk of myocarditis (an inflammation of the heart muscle, myocardium typically caused by viral infections) with FDA officials flagging four cases of myocarditis and pericarditis (“swelling in a membrane surrounding the heart”) from a Novavax clinical trial involving young men aged 16-28 years, according to the CNBC report. 
 

July 14, 2022

New BA.2.75 Omicron Subvariant Detected in Several U.S. States

On July 14, The Hill  reported on the emergence of a new omicron subvariant.

Helix, a company that has been conducting viral surveillance of the coronavirus and providing viral sequencing information to the CDC, disclosed that BA.2.75 has been detected in three states: California, Washington, and Illinois in the past two weeks.
 
Apart from these three U.S. states, Prof. Raj Rajnarayanan of the New York Institute of Technology (who maintains a database that tracks COVID-19 variants) also provided information on the detection of BA.2.75 in New York, North Carolina, Texas, and Wisconsin. 

A recent report from NBC Chicago elaborates why BA.2.75 should be a cause of concern. 

“Scientists say the variant – called BA.2.75 – may be able to spread rapidly and get around immunity from vaccines and previous infection. It’s unclear whether it could cause more serious disease than other omicron variants, including the globally prominent BA.5,” says NBC. 

Director of Clinical Virology Matthew Binnicker (Mayo Clinic—Rochester, MN) says that it’s too early to draw conclusions “but it does look like, especially in India, the rates of transmission are showing kind of that exponential increase.” 

However, detection of this new mutation of the COVID-19 virus in several parts of the world albeit in lower levels “is an early indication that it is spreading,” states Helix Head of infectious Diseases Shishi Luo. 

To date, BA.2.75 has not yet been included in the Centers for Disease Control and Prevention’s (CDC) tracker of variant proportions around the U.S.

Spread of Latest Omicron Subvariants Causing COVID-19 Cases to Spike in California

On July 14, The L.A.Times reported the impact of the BA.4 and BA.5 omicron subvariants in California. According to the report, transmission levels “have been consistently high across virtually all CA counties.”

In particular, Los Angeles County has been experiencing “a renewed increase in cases, now up 14 percent week over week — ending a short period of relative stability following the 4th of July that, in hindsight, likely was related to delays in reporting and reduced testing over the holiday,” L.A. Times further stated, adding that L.A. County “has averaged about 5,900 cases a day over the last week (about 412 cases a week for every 100,000 residents). Note that a rate of 100 or more cases for every 100,000 residents is considered “high.” 

As of July 12, 4,377 COVID-19 positive patients have been hospitalized statewide, with 1,170 in L.A. County. Figures have increased by 61 percent (in California) and 97 percent (in L.A. County). 

L.A. County Department of Public Health Director Barbara Ferrer stated that indoor universal mask-wearing may be reimposed if the county moves into the CDC-defined high COVID-19 community level and remains there for two consecutive weeks. The mask mandate order could take effect as early as July 29, if community levels don’t improve. This will make Los Angeles the only California county to have a mask mandate, should indoor mask-wearing be reimposed. 

To view the most current COVID-19 data in L.A. County, visit the County of Los Angeles Public Health website. 

July 13, 2022

FDA Issues Emergency Use Authorization for Novavax’s COVID-19 Vaccine 

On Wednesday, July 13, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Adjuvanted—Novavax’s COVID-19 vaccine.  The use of Adjuvanted has been authorized “for the prevention of COVID-19 caused by severe acute respiratory syndrome 2 (SARS-CoV-2) in individuals 18 years of age or older.”

“Authorizing an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur such as hospitalization and death,” said FDA Commissioner Robert M. Califf, M.D. “Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization. COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19, and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so,” states FDA in its press release. 
 
According to the FDA, it has determined that Adjuvanted “has met the statutory criteria for issuance of an EUA,” citing data support showing “known and potential benefits of the vaccine that outweigh its known and potential risks in people 18 years of age and older,” and its efficacy in the prevention of a COVID-19 infection. The FDA assures the public and medical community that “a thorough analysis and evaluation of the available safety and effectiveness data and manufacturing information have been conducted.”
 
Adjuvanted is a two-dose primary vaccine series, with the second dose to be administered after three weeks of receiving the first dose. “The vaccine contains the SARS-CoV-2 spike protein and Matrix-M adjuvant,” which is incorporated in some vaccines “to enhance immune response.”  

“The spike protein in this vaccine is produced in insect cells; the Matrix M-adjuvant contains saponin extracts from the bark of the Soapbark tree that is native to Chile,” FDA further adds. 
 
July 12, 2022

Biden Administration Strongly Advises Use of Booster Shots and Antivirals to Fight BA.4 and BA.5 Omicron Subvariants 

In a Washington Post report on Tuesday, July 12, the Biden administration raised concerns about the new wave of COVID-19 cases across the U.S. brought about by the latest omicron subvariants, BA.4 and BA.5, which, according to federal data “now make up 80 percent of circulating virus in the United States.” 
 
Biden officials warned that BA.4 and BA.5 are highly transmissible and have the ability to evade immunity; they are mostly responsible for a rise in the number of cases and hospitalizations, Washington Post further reports.  
 
President Biden’s chief medical adviser for coronavirus response, Anthony S. Fauci also warned those who were infected with the omicron subvariant earlier in the pandemic that they “really don’t have a lot of good protection against BA.4 or BA.5.”
 
White House coronavirus coordinator Ashish Jha stated that the Biden administration’s strategy in managing BA.5 is to rely on “vaccines, antiviral treatments, testing, masking and improved indoor ventilation” to keep Americans from getting hospitalized or dying from COVID-19. 
 
Individuals aged 50 and older are strongly advised to get their first booster shot five months after receiving the last dose of a primary vaccine series, added Jha. 
 

June 29, 2022

Update: Revisions to Evusheld™ Dosing Authorized by FDA

On June 29, the U.S. Food and Drug Administration (FDA) updated its revisions to the emergency use authorization (EUA) for  Evusheld™ (tixagevimab co-packaged with cilgavimab)

"There are different variants (and subvariants) of SARS-CoV-2, and FDA continues to evaluate how well Evusheld neutralizes them. Currently, the omicron BA.2, BA.2.12.1, BA.4 and BA.5 subvariants are circulating in the U.S. Nonclinical data and pharmacokinetic modeling suggest that activity against these subvariants may be retained for six months at drug concentrations achieved following an Evusheld dose of 300mg of tixagevimab and 300 mg cilgavimab,"  the FDA stated.

The FDA revised the Evusheld Fact Sheet for Healthcare Providers "to recommend repeat dosing every six months with a dose of 300 mg of tixagevimab and 300 mg cilgavimab if patients need ongoing protection. The previous Fact Sheet for Healthcare Providers did not provide a specific recommendation on the dosing interval."

The FDA will "continue to monitor the neutralizing activiity of Evusheld against emerging SARS-CoV-2 variants and will provide additional updates as needed."

Please refer to the Frequently Asked Questions for Evusheld for further information. 

 

June 13, 2022

CDC Recommends Getting COVID-19 Vaccine While Pregnant or Breastfeeding

On June 13, the U.S. Centers for Disease Control and Prevention (CDC) updated its recommendations for COVID-19 vaccinations involving those who are pregnant and/or breastfeeding

What You Need to Know

  • If you are pregnant or were recently pregnant, you are more likely to become seriously sick from COVID-19 compared to people who are not pregnant. Additionally, if you have COVID-19 during pregnancy, you are at increased risk of complications which can affect your pregnancy and the developing baby.
  • Getting vaccinated against COVID-19 can help protect you from getting very sick.
  • COVID-19 vaccination is recommended for people who are pregnant, breastfeeding, trying to get pregnant now, or might become pregnant in the future.
  • People who are pregnant should stay up to date with their COVID-19 vaccines, including getting a COVID-19 booster shot when it’s time to get one.
  • Evidence continues to build showing that COVID-19 vaccination during pregnancy is safe and effective.
  • There is currently no evidence that any vaccines, including COVID-19 vaccines, cause fertility problems in women or men.

 

June 10, 2022

Negative Pre-Departure COVID-19 Test Prior to U.S. Flight Rescinded by CDC

On June 10, the U.S. Centers for Disease Control and Prevention (CDC) announced that effective Sunday, June 12 at 12:01 ET, the ORDER for showing a negative COVID-19 test result or documentation of recovery from COVID-19 before boarding a flight to the United States will be RESCINDED. 

Beginning June 12, 12:01 ET, passengers flying into the United States by plane will no longer be required to get tested for COVID-19 nor will they need to present documentation of recovery from COVID-19 prior to boarding a flight to the United States.  

The CDC, however, still recommends that travelers boarding a flight to the U.S. get tested for current infection with a viral test “as close to the time of departure as possible (no more than 3 days) and not to travel if they are sick.”

The CDC continues to evaluate the latest science and state of the pandemic and will reassess the need for a testing requirement if the situation changes. CDC will communicate any updates publicly if and/or when they change,” states the press release. 

CDC Updates to J&J COVID-19 Vaccine: Overview and Safety

On June 10, the CDC updated its recommendations for Johnson & Johnson Janssen COVID-19 vaccine:

“In most situations, Pfizer-BioNTech or Moderna COVID-19 vaccines are preferred over Johnson & Johnson’s Janssen (J&J/Janssen) COVID-19 vaccine, due to risk of serious adverse events. J&J/Janssen should only be considered in some cases and cannot be used as a 2nd booster dose.”

Some of the situations where the J&J/Janssen COVID-19 vaccine may be considered: 

  • For people 18 years and older who had severe reactions after an mRNA vaccine or who have a severe allergy to an ingredient of Pfizer-BioNTech or Moderna (mRNA COVID-19 vaccines).
  • For people 18 years and older who would otherwise remain unvaccinated for COVID-19 due to limited access to Pfizer-BioNTech or Moderna (mRNA COVID-19 vaccines).
  • For people 18 years and older who still want to get the J&J/Janssen COVID-19 vaccine despite safety concerns.
     

May 26, 2022

U.S. Gov’t to Make COVID-19 Antiviral Paxlovid More Accessible at Test-to-Treat Sites 

On May 26, the White House announced that it will make the COVID antiviral drug, Paxlovid® more accessible across the U.S., as reported by AP. This announcement comes as the U.S. government projects another spread of COVID-19 infections during the summer travel season.
 
Additionally, the first federally backed test-to-treat site opened in Rhode Island on Thursday, with more expected to open in the coming weeks in Massachusetts and New York, where there has been a marked increase in COVID-19 infections. The test-to-treat sites will provide those who test positive for COVID-19 with immediate access to the antiviral drug. 
 

The U.S. government will be sending authorized federal prescribers to several testing sites in Minnesota to turn them into test-to-treat locations. Clearer guidance on how to manage Paxlovid’s interactions with other drugs have also been provided to physicians by federal regulators.
 

March 30, 2022

Clinical Guidelines on Administering Evusheld™ Before or After Receiving a COVID-19 Vaccine/Booster

For individuals who received Evusheld™ prior to a COVID-19 vaccination/booster

According to the interim clinical considerations for use of COVID-19 vaccines set by the Center for Disease Control and Prevention (CDC), individuals who previously received antibody products (anti-SARS-CoV-2 monoclonal antibodies or convalescent plasma) such as Evusheld (tixagevimab/cilgavimab) —whether as part of COVID-19 treatment, post-exposure prophylaxis, or pre-exposure prophylaxis —are eligible for a COVID-19 vaccination at any time. There is no need to delay vaccination after receiving monoclonal antibodies or convalescent plasma. 

For individuals who received a COVID-19 vaccine/booster prior to receiving Evusheld™ 

However, for individuals who received a COVID-19 vaccine or booster prior to receiving Evusheld (tixagevimab/cilgavimab), administration of tixagevimab/cilgavimab as pre-exposure prophylaxis should be done at least two weeks after being vaccinated, as indicated in the FDA Fact Sheet.  

February 11, 2022

Emergency Use Authorization for Bebtelovimab for Treatment of Mild to Moderate COVID-19 Among Adults and Pediatric Patients 

On February 11, 2022, The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for bebtelovimab — a new monoclonal antibody for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older, weighing about 88 lbs. or at least 40 kilograms), who tested positive for COVID-19, are at high-risk of developing severe COVID-19 (including hospitalization and death), and when alternative approved or authorized COVID-19 treatment options are not accessible or clinically appropriate. 

However, bebtelovimab is NOT authorized for patients who are hospitalized or require oxygen therapy due to COVID-19 — this treatment has not been studied in hospitalized COVID-19 patients. Monoclonal antibodies (such as bebtelovimab) “may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation,” the FDA warns. 

Based on a review of the”totality of the scientific evidence available,” the FDA has determined that bebtelomivab may be effective in treating mild or moderate COVID-19 and “when used to treat COVID-19 for the authorized population, the known and potential benefits of these antibodies outweigh the known and potential risks.” The FDA notes that “there are NO adequate, approved and available treatments to bebtelovimab.” 

Some facts about bebtelovimab: 

-    Similar to other monoclonal antibodies that have been authorized for treating high-risk patients with mild to moderate COVID-19, bebtelovimab works by binding to the spike protein of the virus that causes COVID-19, therefore reducing the risk of hospitalization and death. 
-    Circulating viral variants are being carefully monitored by the FDA as well as these variants’ sensitivity to authorized monoclonal antibodies (including bebtelovimab). Laboratory tests have shown that bebtelovimab retains activity against the omicron variant and BA.2 omicron subvariant.
-    Some possible side effects of bebtelovimab may include nausea and vomiting, itching, rash, and infusion-related reactions.
-    Serious and adverse effects observed with other SARS-CoV-2 monoclonal antibodies such as hypersensitivity, anaphylaxis, and infusion-related reactions may also occur with bebtelovimab
-    Additionally, clinical worsening following administration of other SARS-CoV-2 monoclonal antibody treatment has been reported and may also be possible with bebtelovimab. It is not known if these events were related to the use of SARS-CoV-2 monoclonal antibodies or if they were due to COVID-19 progression. 

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