The latest on Covid-19 and vaccine boosters

Vaccine advisers to the US Centers for Disease Control and Prevention are meeting now to discuss Covid-19 booster shots a day after the US Food and Drug Administration Wednesday granted emergency use authorization for a booster dose of Pfizer's vaccine for some people.

The FDA said it would grant emergency use authorization for boosters in people 65 and older, people at high risk of severe disease and people whose jobs put them at risk of infection.

The CDC must give its stamp of approval for any booster doses to be officially given.

They are expected to vote on the measure today.

The CDC's Advisory Committee on Immunization Practices can further tweak recommendations for how any vaccine booster doses should be given.

New York Health Commissioner Dr. Howard Zucker has submitted his letter of resignation, according to New York Gov. Kathy Hochul.

He will stay on until the position is filled, she said.  

When asked if the administration put pressure on the New York Health Commissioner to resign, due to his connection to former Gov. Andrew Cuomo and the scandal surrounding the sharing of Covid-19 information in nursing homes, Hochul said, “I made it very clear on my first day in office that I would be looking to build a new team, and I am building that team.

“I’m just taking time to build that team, but there will be other changes forthcoming,” she said.

“I do respect everyone who has been a public servant, I thank them for their service," she added.

New Covid-19 cases have been on the decline over the last week — and while that development is hopeful, one expert is warning it's not time to let down the guard with the Delta variant still spreading and winter on the way.

Over the last week, the seven-day average of new cases has declined by more than 20,000 to about 130,000 cases a day, according to data from Johns Hopkins University. Much of the decline has to do with states that saw huge numbers of Delta variant cases early, such as Florida and Mississippi, coming down off of their peaks, Ranney told CNN on Wednesday.

And for the second consecutive week, an ensemble forecast from the US Centers for Disease Control and Prevention predicts that new daily Covid-19 hospitalizations will likely decrease over the next four weeks.

Last week's forecast, published Sept. 15, predicted hospitalizations would decrease for the first time since the June 23 forecast. This week's forecast predicts that there will be 4,600 to 11,800 new Covid-19 hospital admissions likely reported on Oct. 18.

But the South could still see more cases, and the Northeast could be in for a surge as well, Ranney added. And historically, more cases have been followed by increased hospitalizations — a concerning possibility for many hospitals that are already inundated.

West Virginia recently had its highest number of Covid-19 patients in hospitals on a given day – topping 1,000 for the first time – according to Gov. Jim Justice's office. And across the country, nearly 80% of intensive care unit beds are in use – more than a quarter of those taken up by Covid-19 patients, according to the Department of Health and Human Services.

Despite the call from healthcare professionals for the public to get vaccinated to keep hospitalizations and death rates low, the current pace of people receiving a first dose of a Covid-19 vaccine is the slowest in two months, according to CDC data.

"For the vast majority of us, if you get your vaccines, you are not going to die," Ranney said. "As this disease spreads, it spreads throughout the entire community. It's more likely to catch those more vulnerable people."

The average bill for a Covid-19 hospitalization is about $75,000, and more serious hospitalizations – such as those that require the use of ventilators or days in an ICU – cost more than $300,000 on average, according to a new analysis of insurance claims from FAIR Health. 

After price negotiations, the average allowed amount actually paid by patients and in-network insurance providers is about $33,500 for a general Covid-19 hospitalization and about $98,000 for a more complex hospitalization. 

For this analysis on Covid-19 hospitalizations, FAIR Health – a non-profit organization focused on bringing transparency to health care costs and insurance – assessed claims for inpatient services such as lab tests, radiology, room and board, treatments and specialty drugs, as well as outpatient and provider services such as follow-up office visits and oxygen and respiratory equipment for previously hospitalized patients.  

A separate study published in August found that Covid-19 hospitalizations cost an average of about $22,000 for Medicare fee-for-service enrollees. That’s nearly 150 times more than Medicare pays to reimburse health care providers to fully vaccinate Medicare beneficiaries. Covid-19 vaccines are provided at no direct cost to residents of the United States.

According to the FAIR Health analysis, treatment for Covid-19 that does not result in hospitalization – including lab work, radiology and cardiography procedures – could cost non-insured patients an average of more than $2,500. For insured patients who are treated in-network, the average total cost to insurance and the patient is about $1,000. 

The information about the safety of Covid-19 vaccines in pregnant women is “incredibly reassuring,” the chair of a panel of vaccine advisers to the US Centers for Disease Control and Prevention said Wednesday.

Only 30% of pregnant women in the US have been vaccinated against coronavirus – even as Covid-19 is killing more pregnant women than ever before, the advisers heard during the panel. 

The CDC’s Advisory Committee on Immunization Practices is meeting Wednesday and Thursday to discuss vaccine safety and the potential need for coronavirus vaccine boosters.

The panel heard the latest data on vaccine safety during pregnancy. 

So far, there’s no evidence that getting vaccinated during pregnancy raises the risk of miscarriage or birth defects, several experts said during the meeting.

But pregnant people have a higher risk than most of severe disease if they catch coronavirus, Dr. Dana Meaney-Delman, the CDC’s lead on maternal immunization, said during the meeting.

“We now see increased numbers of pregnant people admitted to the ICU in July and August,” Meaney-Delman said. 

The trend has continued into September, she said.

“The deaths reported in August is the highest number of deaths reported in any month since the start of the pandemic,” Meaney-Delman added.

About 97% of the pregnant people treated in the hospital for Covid-19 have been unvaccinated, she said.

The protection provided by Covid-19 vaccines appears to wane over time, especially for people 65 and older, a US Centers for Disease Control and Prevention expert said Wednesday.

Ruth Link-Gelles, who helps lead the CDC's Vaccine Effectiveness Team, reviewed a series of studies looking at the overall effectiveness of vaccines in various groups between February and August and found similar patterns for Pfizer's and Moderna's vaccines, both made using mRNA.

The findings tended to support the argument that people's protection starts to wane after a few months, and that boosters might help restore their immunity.

Effectiveness started to wane a few months after people were fully vaccinated – defined as two weeks after their second dose of either vaccine.

"For individuals 65 plus, we saw significant declines in VE (vaccine effectiveness) against infection during Delta for the mRNA products," Link-Gelles told the a meeting of CDC vaccine advisers.

The CDC's Advisory Committee on Immunization Practices met Wednesday to discuss the potential need for booster doses of vaccines.

Later Wednesday, the US Food and Drug Administration issued an emergency use authorization to Pfizer for boosters in people 65 and older, those with underlying conditions putting them at high risk of severe disease, and for people whose jobs put them at high risk of exposure.

ACIP will reconvene today to discuss the FDA's EUA and will issue its own recommendations about how it should be applied to the US population. The CDC director must then sign off on these recommendations. They currently will only apply to Pfizer's vaccine.

Link-Gelles said that, overall, Moderna's vaccine effectiveness is higher than Pfizer's. For the Johnson & Johnson vaccine, vaccine effectiveness actually increases with time, even after the Delta variant has dominated.

One study called SUPERNOVA looked at veterans between February and August of this year. In that study, the Pfizer vaccine provided 92% protection against hospitalization for those ages 18 to 64, and 77% for those over 65, Link-Gelles said. The Moderna vaccine provided 97% protection against hospitalization for those 18 to 64, and 87% for those 65 and older. Effectiveness did not seem to be affected by the arrival of the Delta variant, the study found.

A study called IVY looked at hospitalized adults in 18 states between March and August. Efficacy of Pfizer's vaccine waned from 91% 14 to 120 days after full vaccination, to 77% three months or more after full vaccination. Moderna's vaccine effectiveness did not really wane, staying at 92% or 93% in that study.

In a study of 4,000 health care personnel, first responders, and other frontline workers in eight places who were tested every week regardless of symptoms, vaccine protection against any infection declined from 91% pre-Delta to 66% during Delta.

Pfizer told ACIP it hopes and expects that antibody protection from a third dose of its Covid-19 vaccine will last longer than after the initial two doses, but more research will be needed to determine whether more doses would be needed later on.

Read more about this here.

The US Food and Drug Administration said Wednesday it would grant emergency use authorization for a booster dose of Pfizer's Covid-19 vaccine in people 65 and older, people at high risk of severe disease and people whose jobs put them at risk of infection.

"After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for a booster dose in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others," acting FDA Commissioner Dr. Janet Woodcock said in a statement.

On Friday, vaccine advisers to the agency unanimously recommended emergency use authorization for a booster dose of Pfizer's vaccine for people 65 and older and those at risk of severe disease, to be six months after they get the first two doses.

"The FDA considered the committee's input and conducted its own thorough review of the submitted data to reach today's decision," Dr. Peter Marks, who directs the FDA's vaccine arm, the Center for Biologics Evaluation and Research, said in a statement.

"We will continue to analyze data submitted to the FDA pertaining to the use of booster doses of COVID-19 vaccines and we will make further decisions as appropriate based on the data."

It was a consolation prize for Pfizer, which has asked for FDA approval to give its vaccine to everyone 16 and older six months after they are fully immunized with two shots. Pfizer had argued that it had enough evidence that immunity starts to wane after six months and that giving a booster restores the immunity safely.

Vaccine advisers to the US Centers for Disease Control and Prevention have been discussing boosters, and will meet Thursday to act on the FDA's decision. The CDC must give its stamp of approval for any booster doses to be officially given.

CDC's Advisory Committee on Immunization Practices can further tweak recommendations for how any vaccine booster doses should be given.

Read more here.