PANDEMIC PULSE

Pandemic Pulse is a collection of newsworthy updates about the coronavirus pandemic, including the latest scientific and therapeutic developments and changes in public health policy. If you would like to receive notifications when new posts are published, follow us on Twitter and subscribe to our Mailing List.

P.M. Asked: Can I Negotiate Remote Work as a Condition of Employment if I am Immunocompromised?

“I am immunocompromised and thinking of switching jobs. Because of my compromised immune system, I need to work remotely during the coronavirus pandemic to avoid exposure to COVID-19. My current employer allows me to work remotely as a reasonable accommodation, but I don’t want to move to another job if they will not provide it. How can I negotiate remote work as a reasonable accommodation from a prospective employer as a condition of employment?”

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FDA Authorizes First Vaccine Booster for Children 5-11

On May 17, 2022, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine (marketed as Comirnaty) to authorize the use of a single booster dose for children between the ages of five and eleven. The FDA authorized the administration of this booster at least five months after the completion of the primary vaccination series with the same vaccine.

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R.T. Asked: When Can I Get the COVID-19 Booster After Receiving Monoclonal Antibodies?

“When should immunocompromised patients get their second COVID-19 vaccine booster after receiving monoclonal antibodies? We are getting conflicting information from doctors, the news, medical literature, and hospitals on whether it is safe to receive a COVID-19 vaccine or vaccine booster after receiving monoclonal antibodies and whether doing this will reduce the efficacy of the vaccine. We are in a quandary, not knowing what to do.”

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FDA Authorizes the InspectIR COVID-19 Breathalyzer

On April 14, 2022, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to the InspectIR COVID-19 Breathalyzer test. This new diagnostic tool uses a technique called gas chromatography gas mass-spectrometry (GC-MS) to identify whether the SARS-CoV-2 virus is present in a person’s breath.

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mRNA Vaccine Manufacturers Request Authorization for Fourth Dose

On March 15, 2022, Pfizer and BioNTech submitted an amendment to the Emergency Use Authorization for their COVID-19 vaccine (marketed as Comirnaty). This amendment requested that the U.S. Food and Drug Administration (FDA) authorize Comirnaty for a fourth dose for adults 65 years of age and older who have already received one booster dose of any COVID-19 vaccine. Initial data cited by the vaccine manufacturers demonstrated that individuals who received the additional vaccine dose at least four months after receiving the first booster shot experienced a reduction in both confirmed infections and severe illness.

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Sen. Kaine Introduces the CARE for Long COVID Act

On March 2, 2022, Sens. Kaine, Duckworth, and Markey introduced S. 3726, the Comprehensive Access to Resources and Education (CARE) for Long COVID Act. If enacted, this legislation will invigorate the federal government’s response to the growing needs of patients living with long COVID.

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FDA Grants Full Approval to Moderna’s COVID-19 Vaccine

On January 31, 2022, the U.S. Food and Drug Administration (FDA) granted full approval to Moderna’s COVID-19 vaccine for individuals 18 years of age and over. This vaccine will be marketed as “Spikevax,” and is the second COVID-19 vaccine to receive full approval from the FDA following the agency’s approval for Pfizer’s Comirnaty in 2021.

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Biden Administration to Distribute Free N95 Masks

On January 19, 2022, the Biden Administration announced that U.S. residents will be eligible to receive free N95 masks in the coming weeks. 400 million masks will be made available to the public from the Strategic National Stockpile, which currently has over 750 million masks in reserve. These masks will be available for pickup at local pharmacies and communities health centers across the country that have partnered with the federal government’s COVID-19 vaccination campaign and each individual will be eligible to receive up to three masks.

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FDA Grants Emergency Use Authorization for Merck’s Molnupiravir

On December 23, 2021, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for molnupiravir, which is a treatment for COVID-19 manufactured by Merck. The EUA for molnupiravir authorizes its use for the treatment of patients with mild-to-moderate COVID-19 who are at high risk of severe COVID-19 and who are unable to utilize alternate treatment options.

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FDA Grants Emergency Use Authorization for Pfizer’s Paxlovid

On December 22, 2021, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Paxlovid, which is an oral antiviral treatment for COVID-19 manufactured by Pfizer. The EUA for Paxlovid authorizes its use for the treatment of adults and children over the age of 12 with mild-to-moderate COVID-19 who are at high-risk of severe COVID-19.

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EEOC Issues New COVID-19 Guidance, Protecting Workers from Discrimination

On December 14, 2021, the Equal Employment Opportunity Commission (EEOC) amended guidance titled “What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws.” In the amended guidance, the EEOC clarifies that workers with COVID-19 can be protected from discrimination under the Americans with Disabilities Act (ADA). This document expands on guidance issued by the U.S. Department of Health and Human Services (HHS) in September 2021, which included several examples of how long COVID can meet the definition of disability under federal law.

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Pandemic Patients Joins Long COVID Alliance Letter Supporting Research on Long COVID

On December 2, 2021, the Long COVID Alliance, joined by Pandemic Patients and a community of patient advocates, delivered a letter to the Senate Health, Education, Labor & Pensions (HELP) Committee. The Long COVID Alliance submitted this letter to the committee in an effort to persuade the committee to more meaningfully consider the impact of long COVID as a part of the country’s national response to the COVID-19 pandemic.

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FDA Expands Vaccine Booster Eligibility to 16 Years and Older

On December 9, 2021, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine (marketed as Comirnaty). The amended EUA now allows individuals 16 and 17 years of age to receive a booster dose of the Pfizer-BioNTech vaccine at least six months after completion of the primary vaccination series with the same vaccine.

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U.S. House Introduces Legislation to Support Long COVID Patients

On November 17, 2021, US. Reps. DeGette (D-CO) and Upton (R-MI) introduced “21st Century Cures 2.0,” in the House of Representatives. This legislation follows-up on the original 21st Century Act with policy proposals that address public health, the needs of patients and caregivers, and regulations issued by the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS). Importantly, the legislation contains several provisions that support patients with long COVID, including the COVID-19 Long Haulers Act championed by Reps. Beyer (D-VA) and Bergman (R-MI).

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FDA Authorizes Comirnaty for Children 5 to 11

On October 29, 2021, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine (marketed as Comirnaty) to allow children between the ages of five and eleven to receive a pediatric dose of the vaccine.

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FDA Expands Vaccine Booster Eligibility

On October 20, 2021, the FDA amended the Emergency Use Authorization (EUA) for each of the COVID-19 vaccines to expand eligibility for vaccine boosters and to allow the administration of “mix-and-match” boosters.

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Researchers Retract Flawed Myocarditis Study

On September 16, 2021, researchers from the University of Ottawa Heart Institute submitted an article to MedRxiv, which is a preprint server for health sciences where articles can be shared before they are peer reviewed. However, on September 24, 2021, the authors of the preprint study unanimously withdrew the study from publication because it relied on flawed methodology.

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Merck Requests Emergency Use Authorization for Molnupiravir

On October 11, 2021, Merck and Ridgeback Therapeutics announced their Emergency Use Authorization application to the U.S. Food and Drug Administration (FDA) for molnupiravir, which is an investigational oral treatment for mild-to-moderate COVID-19 in adults at risk of hospitalization.

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WHO Formally Defines “Post COVID-19”

On October 6, 2021, the World Health Organization (WHO) published a report titled “A clinical case definition of post COVID-19 condition by a Delphi consensus,” which contains a standardized definition of “Post COVID-19.”

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