John Parkinson

The country announced it is going to study the use of the Johnson & Johnson vaccine for health care workers and will not go forward with plans to use the AstraZeneca vaccine.

The UK announced it is beginning a 2-dose study using one dose of the Pfizer/BioNTech and one dose of AstraZeneca in each individual participant.

The agency limited it Emergency Use Authorization (EUA) for the COVID-19 therapy to the use of high titer COVID-19 convalescent plasma only for the treatment of hospitalized patients early in the disease. FDA is no longer authorizing the use of low-titer plasma in its EUA due to a lack of efficaciousness in further studies.

The company is reporting a reduced transmission after the first and second doses. However, questions are arising on the data around these claims and Switzerland declined to approve the vaccine.

The European Medicines Agency announced today it has recommended granting a commercial marketing authorization (CMA) to the company for its vaccine.

Data for its phase 3 trial shows differing levels of protection for moderate to severe disease depending on the geographic region.

Independent investigators assessed in vitro neutralization potency using the antibody therapy, Regen-Cov, against the B.1.1.7 and B.1.351 strains.

However, there is a six-fold reduction in neutralizing titers in the B.1.351 variant from South Africa, so the company is exploring strategies aimed against new variants.

With the news that the Pfizer and BioNtech COVID-19 vaccine vials can provide an extra dose, the federal agency updated the labeling so as to enable usage of low dead-volume syringes to extract it.

If the current recommended dosing schedules for the vaccines are not “feasible,” then the agency said vaccines may be scheduled for administration up to 42 days between the first and second doses.

Anthony Fauci, MD, made the announcement Thursday morning to the World Health Organization’s (WHO) executive board.

The CDC is saying this highly contagious variant, B.1.1.7, may become the dominant strain of the virus by March.

This vaccine is meant to be delivered as a single dose administration as compared to other vaccines that have been authorized and in development that require a booster shot.

The agency says all travelers must show proof of negative test before boarding.

The agency set a PDUFA date for July 18 for Merck's V114 vaccine.

The agency warns SARS-CoV-2 mutations can trigger potential false negative results in molecular tests.

Chinese company’s investigational vaccine reported to be 78% effective.

This therapy showed a 48% reduction in severe respiratory disease.

While social determinants, stigma about the virus, and continuum of care issues remain challenges to many people with HIV, The IDSA is looking to address these issues with its new guidance.

The FDA’s breakthrough designation of cabotegravir along with adaptive strategies being deployed are the biggest stories in HIV prevention this year.

A principal investigator studying dolutegravir/lamivudine discusses its efficacy and potential treatment benefits.

The authorization recommends dosage intervals of between 4 and 12 weeks.

Trial to enroll up to 30000 volunteers across approximately 115 sites in the US and Mexico.

With the public beginning to get vaccinated, CDC published information for people in some medical categories and considerations on severe allergic reactions.

The new COVID-19 variant, B.1.1.7, continues to make its way around Europe and the world with new cases.

Vaccine manufacturer Valneva recently announced it was initiating a phase 1/2 trial in the United Kingdom.

Review of data in trial registries shows they specifically excluded this group from studies involving therapies.

Covaxx CEO Mei Mei Hu has seen vaccines from development all the way through to government approval. She offers her unique perspective into vaccine creation and an update on her company’s COVID-19 vaccine.

In a mature market of agents, the investigational therapy, ibrexafungerp, from Scynexis is looking at a few antifungal indications with a potential FDA approval in 2021.

This non-prescription test allows users to perform and get results themselves without a medical provider or laboratory needed.