Tag archives: vaccine

US OSHA issues COVID vaccine and testing Emergency Temporary Standard

On Friday, November 5, 2021, the federal Occupational Safety and Health Administration (“OSHA”) published an Emergency Temporary Standard (“ETS”) “to protect unvaccinated employees of large employers (100 or more employees) from the risk of contracting COVID-19 by strongly encouraging vaccination.” The ETS compels covered employers to develop and enforce a mandatory COVID-19 vaccination policy unless … Continue reading

CMS Issues COVID-19 Vaccine Mandate Interim Final Rule

On November 4, 2021, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule requiring that Medicare-certified providers implement policies for vaccination of all health care workers against COVID-19.  Compliance with the requirement will be a Condition of Participation in the Medicare program, and providers may be subject to survey, requests for … Continue reading

COVID-19 Update: Panel of FDA Vaccine Advisers Vote in Favor of Vaccination for Children

On Tuesday, October 26, 2021, the FDA’s Vaccines and Related Biological Products Advisory Committee members voted to approve vaccinations for children aged 5 through 11. Specifically, the panel addressed the following question: “Based on the totality of scientific evidence available, do the benefits of the Pfizer . . . Vaccine when administered as a 2-dose … Continue reading

COVID-19 Update: White House Plan for Vaccinating Children

On Wednesday, October 20, 2021, the White House discussed in a press conference its plan for vaccinating children aged 5 through 11. The White House stated it has worked closely with “governors, pediatricians, pharmacies, community health centers, rural health centers, and other vaccine providers” in preparation of a vaccine rollout. Of course, these plans are … Continue reading

COVID-19 update: FDA warns against COVID-19 vaccine for children younger than twelve

On September 10, 2021, the Acting Commissioner of Food and Drugs, Janet Woodcock, M.D., and Director of the Center for Biologics Evaluation and Research, Peter Marks, M.D., PhD., issued a statement on behalf of the FDA regarding the vaccination of children under the age of twelve. The FDA noted there are different issues that need … Continue reading

COVID-19 Update: Biden Administration requires COVID-19 vaccine or proof of negative COVID-19 test for employees at large companies

On September 9, 2021, President Biden announced a new, upcoming mandate that requires all employers with 100 or more employees “to ensure their workforce is fully vaccinated or require any workers who remain unvaccinated to produce a negative test result on at least a weekly basis before coming to work.” The Biden Administration projects this … Continue reading

COVID-19 Update: Pfizer vaccine fully approved by FDA

On August 23, 2021, the US Food and Drug Administration (“FDA”) granted full approval for the Pfizer-BioNTech COVID-19 (“Pfizer”) vaccine for individuals sixteen-years-old and older. This change shifts the vaccine from emergency-use only and is the first COVID-19 vaccine granted approval by the FDA in the United States. For individuals aged twelve through fifteen, the … Continue reading

COVID-19 Update: Pfizer-BioNTech Vaccine Approved for Teens

On May 10, 2021 the U.S. Food and Drug Administration (“FDA”) announced that the Pfizer-BioNTech Emergency Use Authorization (“EUA”) would be expanded to include children ages 12-15.  Previously, the vaccine had been approved for individuals 16 and older.  The press release stated that between March 1, 2020 and April 30, 2021 there were approximately 1.5 … Continue reading

COVID-19 Update: U.S. Centers for Disease Control and Prevention Updates Mask Guidelines

On Tuesday, April 27, 2021, the U.S. Centers for Disease Control and Prevention (“CDC) unveiled updated guidelines detailing activities that vaccinated people can safely resume. The guidelines continue the trend of public health authorities relaxing previous guidelines for individuals that have received a COVID-19 vaccine.  See Health Law Pulse posts here, here and here. After … Continue reading

COVID-19 Update – HHS OCR Releases Legal Guidance for Expanding Vaccine Access to People with Disabilities and Older Adults

On April 13, 2021, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) published a press release with resources, including from the Administration for Community Living (“ACL”) and the Office of the Assistant Secretary for Planning and Evaluation (“ASPE”), to improve access to vaccinations for individuals with disabilities and older adults. … Continue reading

COVID-19 Update: CDC Releases Guidance for Vaccinated Individuals

Ever since the U.S. declaration of a public health emergency on March 13, 2020, Americans have wondered what life would look like if and when a vaccine was developed.  In December, the first vaccine was administered in the U.S.  On March 8, 2021, the positive momentum accelerated when the U.S. Centers for Disease Control and … Continue reading

COVID-19 Update: First Person Receives COVID-19 Vaccine in U.S.

Almost eleven months after the first confirmed coronavirus patient in the State of Washington (HL Pulse post here), the first dose of Pfizer and BioNTech’s COVID-19 vaccine was administered in the U.S. to a critical care nurse a little after 9:00 a.m. ET.  This happened just three days after the U.S. Food and Drug Administration … Continue reading

COVID-19 Update: First COVID-19 vaccine approved in UK

On December 2, 2020 the United Kingdom’s Medicines and Healthcare Products Regulatory Authority (“MHRA”) announced approval of Pfizer and BioNTech’s coronavirus vaccine.  According to a press release from the U.K. government: This was done using a regulatory process known as a ‘rolling review’. A ‘rolling review’ can be used to complete the assessment of a … Continue reading

COVID-19 Update: First EUA for COVID-19 Vaccine Filing Imminent; CDC Urges Americans Not to Travel for Thanksgiving

On Friday November 20, Pfizer and BioNTech announced they would submit a request to the U.S. Food and Drug Administration (“FDA”) seeking Emergency Use Authorization for their vaccine candidate.  Earlier this week, the companies announced that at the completion of their Phase 3 trial, the vaccine was 95 percent effective.  In addition to the effectiveness, … Continue reading

COVID-19 Update: Progress toward a vaccine candidate

On November 9, Pfizer and its German counterpart BioNTech announced initial clinical results found their coronavirus vaccine candidate to be more than 90 percent effective. Pfizer will wait to seek Emergency Use Authorization (“EUA”) from the US Food and Drug Administration (“FDA”) under Section 564 of the Food, Drug, and Cosmetic Act. Clinical study subjects must … Continue reading

COVID-19 Update: Biopharmaceutical Executives Release Joint Statement on Vaccine

Chief executive officers of nine biopharmaceutical companies signed an unprecedented joint pledge, entitled BIOPHARMA LEADERS UNITE TO STAND WITH SCIENCE, acknowledging the U.S. Food and Drug Administration’s (“FDA”) role in the development of a COVID-19 vaccine, and pledging to: Always make the safety and well-being of vaccinated individuals our top priority. Continue to adhere to … Continue reading

The European Court of Justice lowers causation standard of proof, finds vaccine could cause multiple sclerosis absent hard science

In an opinion that could significantly lower the threshold for proof of general causation in product liability lawsuits if adopted elsewhere, on June 21, 2017, the European Court of Justice held that a court could find a vaccine “defective” and thus the cause of a disease, even where no medical research supported such a causal … Continue reading
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