Week LXXX: Vaccine manufacturers release studies

Enterprise file photo — Michael Koff
Angelica Sofia Parker, 12, of Guilderland was vaccinated against COVID-19 in May as soon as her age group was allowed. On Monday, Pfizer and BioNTech announced their vaccine is safe and effective for children between the ages of 5 and 11.

ALBANY COUNTY — Vaccine news dominated the county’s 80th week of coping with the coronavirus.

Albany County reached a positive milestone on Tuesday with more than 200,000 of its roughly 307,000 residents fully vaccinated.

“It’s critical that we continue to build on this momentum and have even more people get vaccinated so we can protect our community by reaching herd immunity,” said Albany County Executive Daniel McCoy in his daily release.

He also reported that, between Sept. 12 and 18, the county’s health department identified 568 new COVID-19 infections. Of those analyzed, 243 were fully vaccinated, 281 were not — and for 44 cases, the vaccination status was unknown or the individual declined to respond.

Nationally, both Johnson & Johnson and Pfizer-BioNTech had news about their vaccines this week.

On Monday, Pfizer and BioNTech announced their vaccine is safe and effective for children between the ages of 5 and 11, and they plan to submit their data to the Food and Drug Administration and to other regulatory agencies around the world as soon as possible.

Currently, only Americans 12 and older can get an authorized vaccination.

The companies state, “Results in children under 5 years of age are expected as soon as later this year.”

On Tuesday, Johnson & Johnson — which had a single-shot vaccination as opposed to the two shots specified for the messenger RNA vaccines — reported on its study, showing that a second shot given two months after the first greatly improved efficacy.

In the United States, the trial showed that, while a single shot provided 74-percent efficacy against severe symptoms, 89-percent against hospitalization, and 83-percent against COVID-19-related death, a second shot provides 94 percent protection against moderate to severe COVID-19 and 100 percent protection against critical COVID-19.

“When a booster of the Johnson & Johnson COVID-19 vaccine was given two months after the first shot, antibody levels rose to four to six times higher than observed after the single shot ...,” Johnson & Johnson reported. “When a booster of the Johnson & Johnson COVID-19 vaccine was given six months after the single shot, antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster. All rises were irrespective of age.”

Johnson & Johnson has provided its data to the FDA.

On Monday, Albert Bourla, chairman and chief executive officer of Pfizer, had noted in its release, “Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. — underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”

The Pfizer trial involved 2,268 participants who were 5 to 11 years old and received a two-dose regimen of the vaccine, at a lesser strength than the adult vaccine.

“The vaccine was safe, well tolerated and showed robust neutralizing antibody responses,” the companies state.

“The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose,” said  Ugur Sahin, chief executive officer and co-founder of BioNTech, in the release.

Hospitalizations and deaths in the United States have surged in recent months, primarily among the unvaccinated. Pediatric hospitalizations have been on the rise, too, as the non-dominant Delta variant is more contagious. Roughly a quarter of Americans are still not vaccinated.

While President Joe Biden in August had made the case for third shots for people who had gotten messenger RNA vaccinations — Pfizer-BioNTech or Moderna — an FDA advisory panel last Friday rejected that plan, recommending Pfizer booster shots only for people 65 or older; for people at high risk for serious disease; or for first responders, health-care workers, and others at high risk of infection.

The Centers for Disease Control and Prevention and the FDA have yet to weigh in on the matter.

 

Travel restrictions to be lifted

Also on Monday, the White House announced that the 18-month travel ban imposed on 33 countries will be lifted in November.

“In early November, we’ll be putting in place strict protocols to prevent the spread of COVID-19 from passengers flying internationally into the United States by requiring that adult foreign nationals traveling to the United States be fully vaccinated,” said Press Secretary Jennifer Psaki in a briefing on Monday. “Obviously, this is the conclusion of a policy process on that particular issue — an important one facing many people around the world.”

Psaki said of unvaccinated Americans who would be flying home from foreign travel, “So, there would still be requirements for these — for individuals — Americans who are not vaccinated — including providing proof of a negative test result taken within one day of their departure and providing proof they have purchased a viral test to be taken after arrival for Americans who are not fully vaccinated — which, at this point, would obviously apply to children as well.”

She also said that contact-tracing is part of the plan. “CDC is going to issue a contact-tracing order that will require airlines to collect comprehensive contact information for every passenger coming to the United States and to provide that information promptly to the CDC, upon request, to follow up with travelers who have been exposed to COVID-19 variants or other pathogens,” said Psaki. “And these requirements will apply globally ... 

“As we were making these policy decisions, we had to account for and plan for and ensure that we could implement this policy in a way that was clear, that was equitable, that provided — that ensured that there was equal treatment around the world of how people could come into the United States given COVID protocols.”

The international travel announcement did not include an opening of land borders to Mexico or Canada; non-essential travel there is still banned.

“Title 19 is what is in place, of course, at land borders; it’s being extended for another month, through October 21st,” said Psaki. “We don’t have any updates or predictions at this point in time. But, obviously, we’re continuing to consider — as is evident by our announcement today — how we can return to a place of travel and people being able to move from country to country, including at our land borders.”

 

Staff shortage

On Wednesday, the American Health Care Association and National Center for Assisted Living, representing more than 14,000 nursing homes and long-term care facilities across the country, released a survey of nursing home and assisted living providers, showing severe staff shortages with more than a third very concerned about having to shut their facilities.

New York State has set a deadline for workers in hospitals and nursing homes to be vaccinated against COVID-19 by Sept. 27 while workers in home-care agencies, hospices, and adult-care facilities must be vaccinated by Oct. 7.

This mandate is being challenged in federal court by 17 unnamed health-care workers, resulting in a temporary restraining order. Their complaint calls the vaccine mandate unconstitutional, nullifying protections for sincere religious beliefs granted under Title VII of the Civil Rights Act of 1964.

Governor Kathy Hochul has said that allowing health-care workers to regularly test negative for COVID-19 was intentionally left out of the regulations.

“We’ll be defending this in court,” she said, noting the court date is Sept. 28 — which is a day after the mandate was to go into effect.

Results from the American Health Care Association and National Center for Assisted Living survey show that nearly every nursing home (99 percent) and assisted living facility (96 percent) in the United States is facing a staffing shortage; 59 percent of nursing homes and nearly one-third of assisted living providers are experiencing a high level of staffing shortages.

More than seven out of 10 nursing homes and assisted living communities said a lack of qualified candidates and unemployment benefits have been the biggest obstacles in hiring new staff.

Due to these shortages, nearly every nursing home and assisted living community is asking staff to work overtime or extra shifts. Nearly 70 percent of nursing homes are having to hire expensive agency staff while 58 percent of nursing homes are limiting new admissions.

Seventy-eight percent of nursing homes and 71 percent of assisted living facilities are concerned workforce challenges might force them to close. More than one-third of nursing homes are very concerned about having to shut down their facilities.

 

Pop-up sites for schools

On Tuesday, Hochul announced that, over the next 12 weeks, 120 new pop-up sites will vaccinated young new Yorkers as part of the #VaxtoSchool campaign.

Speaking in Brooklyn, she said, “We're here for one reason. One reason. That's to protect our children. And I come at this as a mother who knows from the second you first hold that baby, you are hardwired to do everything in your power to protect them. It’s that simple.”

She also stressed the importance of in-person learning, calling last year’s remote learning an “interesting experiment.,” adding, “It ended up being a disaster.”

The “vax to school” campaign will target communities with low vaccination rates among young people, particularly communities of color, Hochul said.

The campaign has a website at ny.gov/vaxtoschool with resources and materials, including information and an FAQ for parents and guardians, as well as ready-made signs for school leaders. The site will be updated with new information about the #VaxtoSchool campaign, including pop-up sites and incentive efforts.

The state has also launched an Instagram channel, @VaccinateNY, to educate school-aged New Yorkers and their families about the COVID-19 vaccine directly.

 

Newest numbers

Albany County suffered no new COVID-19 deaths in its 80th week of battling the virus; the death toll remained at 400.

But the hospitalizations continued to mount.

On Tuesday, McCoy said in his daily release, “Unfortunately, we’ve seen the number of county residents hospitalized with COVID steadily rise over the last week, and the last time we had 40 people in the hospital at one time was back on March 5. And the latest data is showing that among those hospitalized, 70 percent are not vaccinated, 5 percent are partially vaccinated and 25 percent are fully vaccinated.

On Wednesday, McCoy reported six new hospitalizations with 39 county residents hospitalized with the virus — a net decrease of one. There are currently 10 patients in intensive-care units, unchanged from Tuesday. 

On three days this week, McCoy reported new cases of COVID-19 in the triple digits. On Wednesday, he reported 79 new cases, bringing down Albany County’s five-day average to 82.

Among the new cases, 61 did not have a clear source of infection identified, 12 had close contact with someone infected with the virus, five are health-care workers or residents of congregate living settings, and one reported traveling out of state.

There are now 512 active cases in the county, down from 536 Tuesday.

The number of Albany County residents under quarantine decreased to 1,064 from 1,119.

Albany County, like New York State and every state in the nation except California, is labeled by the Centers for Disease Control and Prevention as having a high rate of transmission — California’s rate is labeled as substantial — both of which trigger wearing masks indoors in public regardless of vaccination status.

According to the state’s dashboard, Albany County’s infection rate, as of Monday, as a seven-day average, is 4.5 percent; statewide, the rate is 3.0 percent.

According to the state’s vaccine tracker, 71.0 percent of Albany County’s 307,117 residents have had at least one dose of vaccine as have 82.0 percent of county residents 18 and older.

Statewide, 70.1 percent of New Yorkers have had at least one dose as have 82.8 percent of New Yorkers 18 and older. At the same time, 62.7 percent of New Yorkers have completed a vaccine series while 74.3 percent of New Yorkers 18 and older have completed a series.

Albany County continues to deliver vaccines to homebound residents, which includes seniors, people with disabilities, those lacking childcare, and those with other accessibility issues. Anyone who would like to schedule a time for a vaccine appointment should call 518-447-7198.

Residents can also receive free Pfizer and Johnson & Johnson vaccines Monday through Friday, from 9 a.m. to 3 p.m., each week at the Albany County Department of Health at 175 Green Street. Residents 12 and older are currently eligible. No appointments are needed and walk-ins are welcome.

More Regional News

  • New York State Capitol

    Starting on Monday, visitors to the capitol must be fully vaccinated or provide proof of a negative COVID test within 48 hours, the Office of General Services announced on Saturday. The office also announced that the Legislative Office Building will be closed until further notice “as a necessary precaution in response to the evolving COVID-19 situation.”

  • free test kits

    On Tuesday morning, Albany County Executive Daniel McCoy reported that Albany County had a seven-day average positivity rate of 18.3 percent. On May 12, 2020, the World Health Organization advised governments that, before reopening, rates of positivity in testing  — that is, out of all tests conducted, how many came back positive for COVID-19 — should remain at 5 percent or lower for at least 14 days.

  • “While New York as a whole is showing signs of statewide COVID infections possibly hitting their peak, that is clearly not the case for Albany County as we report nearly 1,600 new positive cases in a single day, the highest increase we’ve ever experienced since the pandemic started nearly two years ago,” said Albany County Executive Daniel McCoy.

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