COVID-19 vaccine for younger children, booster shot halfway prepared in U.S.
The FDA is likely to authorize Pfizer booster shots this week for many Americans at high risk of falling seriously ill from the coronavirus, now that a key advisory committee has voted to recommend the measure, media reported.
COVID-19 vaccine for younger children and booster shots for at least those over 65 years old are being prepared in accordance with a tight schedule in the United States, as the Americans stagger into the 19th month of their fierce fight against the COVID-19 pandemic.
The 7-day average of confirmed cases of the pandemic stood at 148,202 nationwide on Sunday, with its 14-day change striking an 8-percent fall, according to The New York Times (NYT). COVID-19-related deaths were 2,011 on Sunday, with the 14-day change realizing a 29-percent rise.
California, once the country's epicenter of COVID-19, is now the U.S. state reporting the lowest positivity rate per 100,000 people. As of Saturday evening, 24.99 new confirmed cases were reported for every 100,000 people in this Golden State, according to Johns Hopkins University.
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SHOT FOR CHILDREN
A lower dose of the Pfizer-BioNTech coronavirus vaccine, one-third the amount given to adults and teens, is safe and triggered a robust immune response in children as young as 5 years old, the drug companies announced in a news release Monday morning.
"The finding, eagerly anticipated by many parents and pediatricians, is a crucial step toward the two-shot coronavirus vaccine regimen becoming available for younger school-aged children, perhaps close to Halloween," reported The Washington Post.
However, the companies must prepare and submit the data to the U.S. Food and Drug Administration (FDA), a process they expect to complete by the end of September. Then, the data, not yet published or peer reviewed, will be scrutinized by regulators to ascertain that the vaccine is safe and effective. That could take weeks, or up to a month.
According to the companies, the two-dose shot was found to be safe and well tolerated among the children in the study, with the vaccine generating levels of antibodies that were similar to those of younger adults, which met the study's measurements of success.
Meanwhile, Pfizer and BioNTech said that they had not yet determined vaccine efficacy, or how well it protects against COVID-19 for children in the age group.
"We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children," Pfizer Chief Executive Albert Bourla said in a statement.
BOOSTER IN SIGHT
The FDA is likely to authorize Pfizer booster shots this week for many Americans at high risk of falling seriously ill from the coronavirus, now that a key advisory committee has voted to recommend the measure, reported NYT on Monday.
On Friday, a panel of experts endorsed offering Pfizer booster shots for those aged 65 and older, and people 16 and over who are at high risk of getting severe COVID-19 or who work in settings that make them more likely to get infected.
The agency, which often follows the committee's advice but is not required to, is expected to decide early this week. An advisory committee of the Centers for Disease Control and Prevention (CDC) is scheduled to meet on Wednesday and Thursday to discuss booster shots before that agency, which sets vaccine policy, issues its recommendations.
Interviewed with news media on Sunday, Anthony Fauci, the nation's top infectious disease doctor and an adviser to the White House, asked Americans to be patient and not to get a booster shot until they were eligible. That includes people aged 65 and over who received the Moderna and Johnson & Johnson vaccines.
Last month, the Biden administration proposed a plan that would have made all vaccinated Americans eligible for a booster shot eight months after their second shot, or their first in the case of the one-shot Johnson & Johnson vaccine.
In the meantime, the expert panel concluded that boosters were not necessary for most younger, healthier Americans, unless their jobs put them at special risk for infection.
RISING INSURANCE
In 2020, as the pandemic took hold, U.S. health insurance companies declared they would cover 100 percent of the costs for COVID-19 treatment, waiving co-pays and expensive deductibles for hospital stays that frequently range into hundreds of thousands of dollars.
But this year, most insurers have reinstated co-pays and deductibles for COVID-19 patients, in many cases even before vaccines became widely available. "The companies imposed the costs as industry profits remained strong or grew in 2020, with insurers paying out less to cover elective procedures that hospitals suspended during the crisis," reported The Washington Post on Monday.
Now the financial burden of COVID-19 is falling unevenly on patients across the country, varying widely by health-care plan and geography, according to a survey of the country's two largest health plans in every state by the nonprofit and nonpartisan Kaiser Family Foundation.
Last year, according to the Kaiser Family Foundation, 88 percent of people covered by private insurance had their co-pays and deductibles for COVID-19 treatment waived. By August 2021, only 28 percent of the two largest plans in each state and Washington, D.C. still had the waivers in place, and another 10 percent planned to phase them out by the end of October.
America's Health Insurance Plans (AHIP), the industry's lobbying and trade group, said insurance companies began to reinstate cost-sharing for COVID-19 treatment as vaccines became available and in recognition that the coronavirus will be an ongoing health challenge.
"After a year and a half, it's pretty clear that COVID-19 is here to stay, that this is a continuing health condition," AHIP spokesman David Allen was quoted as saying. "When it comes to treatment, we're looking at it like we would treat any other health condition."
