J&J, Astra Zenica Seek Vaccine Approvals, 39,000 Seniors Saved, World Stats, More

J&J asks for emergency use authorization of coronavirus vaccine booster

Johnson & Johnson vials

© Getty Images

Johnson & Johnson announced Tuesday that it has asked the Food and Drug Administration (FDA) to grant emergency authorization for a booster shot of its COVID-19 vaccine for individuals aged 18 years and older.

In a statement, the company said it based its filing on the results of a late-stage clinical trial that found a booster dose of its single-shot vaccine given 56 days after the first dose provided 94 percent protection against symptomatic COVID-19, and 100 percent protection against severe and critical disease at least 14 days after the second dose.

The move comes as the Biden administration ramps up its campaign to administer booster doses.

The U.S. began rolling out booster doses late last month. More than 5.7 million people have received a booster dose, according to data from the Centers for Disease Control and Prevention.

The FDA has already authorized booster shots for Pfizer’s vaccine for individuals aged 65 and older and those at high risk of severe disease.

Moderna has also begun submitting data to the agency about a booster dose of its vaccine.

Coming up, FDA meeting: The FDA’s vaccine advisory panel will meet later this month to discuss booster doses of Moderna and J&J’s vaccine. Both vaccines are currently authorized for adults aged 18 and older.

ANOTHER FDA REQUEST: ASTRAZENECA’S COVID-19 PREVENTATIVE TREATMENT

AstraZeneca also submitted a request for emergency use authorization on Tuesday — for an antibody drug designed to help prevent symptomatic COVID-19.

The antibody therapy, called AZD7442, provides “statistically significant reduction” in the risk of developing COVID-19 and could provide another protective measure for vulnerable populations, including the immunocompromised, against the deadly disease, the company said in a statement.

In its application to the Food and Drug Administration (FDA), AstraZeneca cited data from a trial showing the drug was 77 percent effective at thwarting symptomatic COVID-19. More than three-quarters of the tested population were immunocompromised or had other comorbidities associated with serious illness.

Significance: If the FDA grants emergency use authorization for the drug, it will be the first long-acting antibody cocktail to receive such approval for COVID-19 prevention, the company said.

Mene Pangalos, AstraZeneca’s head of biopharmaceuticals research, said the antibody combination will help people who do not have a fully immune response to COVID-19 vaccines and need more to adequately prevent infections.

“With this first global regulatory filing, we are one step closer to providing an additional option to help protect against COVID-19 alongside vaccines,” Pangalos said in the release.

COVID-19 vaccines may have saved the lives of 39,000 seniors in US: HHS study

A nurse prepares a dose of the Pfizer-BioNtech COVID-19 vaccine

© Getty Images

COVID-19 vaccines may have saved the lives of tens of thousands of seniors nationwide earlier this year, according to estimates from a Department of Health and Human Services (HHS) report released Tuesday.

The study suggests that COVID-19 vaccinations may have prevented about 265,000 infections, 107,000 hospitalizations and 39,000 fatalities among Medicare recipients in the first five months of 2021.

Researchers specifically found the vaccines may have stopped 5,600 deaths among nursing home Medicare beneficiaries — a population hit hard by the pandemic prior to vaccines.

The vaccination rate among seniors climbed from 1 percent to 80 percent over that five-month period. Weekly COVID-19 hospitalizations and deaths among Medicare recipients decreased by 11 to 12 percent for every 10 percent increase in county vaccination rates.

All racial and ethnic groups, as well as the 48 states included in the study, estimated a decrease in cases, hospitalizations and deaths associated with jumps in the vaccination rate. Texas and Hawaii were excluded from the analysis because of “data reporting limitations.”

What this means: The HHS report signals the effectiveness of the vaccines in potentially averting senior deaths after the majority of fatalities before shots occurred among people ages 65 and older who were eligible for Medicare.

HHS Secretary Xavier Becerra said the report backs up the Biden administration’s push to vaccinate the country and prioritize older populations, showing these doses “save lives, prevent hospitalizations, and reduce infection.”

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WORLD STATS

Coronavirus Cases:

236,668,135

Deaths:

4,833,157

Recovered:

213,770,203

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