FDA will likely extend booster authorization to younger people, former commissioner says
From CNN's Lauren Mascarenhas
Dr. Scott Gottlieb (CNN)
The US Food and Drug Administration is likely to extend emergency use authorization of a Pfizer Covid-19 vaccine booster to younger age groups as more data comes in, former FDA Commissioner Dr. Scott Gottlieb said Wednesday.
The FDA decided Wednesday to grant emergency use authorization for a booster dose of the Pfizer Covid-19 vaccine in people ages 65 and up, those at high risk of severe disease and people whose jobs put them at risk of infection.
As more data is collected, the FDA may expand the authorization to younger age groups, Gottlieb noted.
“I suspect what's going to happen is we'll continue to collect data on this cohort, 65 and over and other people who are made eligible, and eventually the agency may walk down the authorization to younger age cohorts, depending on what they learn from the data set here in the United States,” he told CNN.
Gottlieb said that the US Centers for Disease Control and Prevention’s vaccine advisers will reconvene Thursday to interpret the FDA’s authorization, which could apply to a “broad” portion of the population.
“It could include a lot of people who are at high risk from a bad outcome from Covid, because they're more likely to come into contact with the disease – that they're working in occupations where they're put at risk of contracting the illness as well," he added.
7:42 p.m. ET, September 22, 2021
FDA gives emergency use authorization for a booster dose of Pfizer's Covid-19 vaccine
From CNN's Maggie Fox
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.
“Today’s action demonstrates that science and the currently available data continue to guide the FDA’s decision-making for COVID-19 vaccines during this pandemic. 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.
Pfizer had asked for full approval for a booster dose for everyone 16 and older who’d been fully vaccinated with two doses if its vaccine, saying there was evidence immunity was waning with time. The FDA’s vaccine advisers met Friday and voted to recommend emergency use authorization, not full approval, for a booster dose for people 65 and older, those at high risk of severe Covid-19 and people at high risk of infection because of their jobs, such as health workers.
The US Centers for Disease Control and Prevention’s vaccine advisers have been meeting to discuss the possible need for a booster dose. They’ll reconvene Thursday to decide on what to recommend, based on the FDA’s decision. Then the CDC director will sign off on the advisory committee’s recommendation. Once that happens, eligible people could start getting booster doses right away.
The CDC and FDA have already OK'd third doses for certain people with immunocompromising conditions who may not have responded fully to the first two shots, and about 2.3 million Americans have already received boosters. The FDA is also considering an application from Moderna for boosters, and Johnson & Johnson has said it is consideration an application for boosters.
7:04 p.m. ET, September 22, 2021
NYC teachers and staff must prove vaccination to work in-person following judicial order
From CNN's Rob Frehse
New York City teachers, staff, city employees and contractors who work in-person in Department of Education schools or buildings must prove they have been vaccinated or prove they have received the first dose of a two-dose vaccine by Sept. 27, after a judge lifted a temporary restraining order against the city.
Those who are not vaccinated must also prove they got the second dose within 45 days of the first, according to the order of the commissioner of the Department of Health and Mental Hygiene.
The New York City Municipal Labor Committee, along with other individuals, sued the city, the city’s Department of Health and Mental Hygiene (NYCDOMH) and the Board of Education for the city’s school district seeking to vacate the commissioner of Mental Hygiene’s Aug. 24 order forcing vaccinations.
New York Supreme Court Judge Laurence Love issued the temporary restraining order on Sept. 14 but lifted it Wednesday because NYCDOMH Commissioner Dave A. Chokshi updated the language in the city’s vaccine mandate.
CNN reached out to the New York City Municipal Labor Committee and New York City Mayor Bill de Blasio’s office for comment.
CNN’s Liam Reilly contributed to this report.
5:58 p.m. ET, September 22, 2021
Data on vaccine safety for pregnant people is "incredibly reassuring," CDC advisers say
From CNN's Maggie Fox
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.
“It has been incredibly reassuring to date,” Dr. Grace Lee, a professor of pediatrics at Stanford University School of Medicine and chair of ACIP, told the meeting.
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.
5:47 p.m. ET, September 22, 2021
CDC's vaccine advisers will wait for FDA to talk any more about boosters
From CNN's Maggie Fox
Vaccine advisers to the US Centers for Disease Control and Prevention will wait to hear more from the US Food and Drug Administration before discussing any further the need for Covid-19 vaccine boosters.
The CDC’s Advisory Committee on Immunization Practices met Wednesday to discuss the possible need for a third or booster dose of vaccine for people already vaccinated. Pfizer has asked the FDA to approve a booster for its vaccine recipients. A possible second day of discussions is scheduled for Thursday.
Vaccine advisers to the FDA met Friday and recommended that boosters be authorized – not fully approved – for people 65 and older, people at risk of severe Covid-19 illness and people at high risk of infection because of their jobs, such as healthcare workers. The FDA has yet to act on that advice.
“If there is an FDA authorization by noon tomorrow we will be holding the meeting as scheduled,” Dr. Amanda Cohn, CDC’s senior adviser for vaccines and executive secretary for ACIP, told the meeting.
Otherwise, Thursday’s meeting may be rescheduled, she said.
5:32 p.m. ET, September 22, 2021
The pace of Covid-19 vaccinations is the slowest it's been in 2 months, CDC data shows
From CNN's Deidre McPhillips
Registered Nurses Amber Boyd, left, and Darian Sumbingco, right, discuss concerns with a woman deciding to receive the Covid-19 vaccine at a vaccination clinic for homeless people, hosted by the Los Angeles County Department of Public Health and United Way on Wednesday, September 22, in Los Angeles. (Frederic J. Brown/AFP/Getty Images)
There are 182 million people in the US who have been vaccinated against Covid-19, according to data published Wednesday by the US Centers for Disease Control and Prevention.
That number represents 54.9% of the total US population.
Aside from a small post-Labor Day uptick, the pace of vaccinations has slowed recently, according to the data. The current pace is the slowest it’s been in two months.
Some more highlights from the data:
Not vaccinated: 25.1% of the eligible population (12 years and older), about 71 million people
Current pace of vaccinations (seven-day average): 312,037 people are initiating vaccination each day.
This is a 7% drop from last week and a 35% drop from a month earlier.
An average of 742,703 doses are being administered each day.
About 2.3 million people have received an additional dose – or booster – since Aug. 13.
31states have fully vaccinated more than half of their residents: Arizona, California, Colorado, Connecticut, Delaware, Florida, Hawaii, Illinois, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Rhode Island, South Dakota, Texas, Vermont, Virginia, Washington and Wisconsin, as well as Washington, DC.
3:55 p.m. ET, September 22, 2021
People vaccinated against Covid-19 while pregnant pass protection to newborns, small study says
From CNN's Jen Christensen
People who get the Covid-19 vaccine while they are pregnant pass a high level of protection onto their newborns, according to a small study published Wednesday.
Researchers from the New York University Grossman School of Medicine tested the umbilical cord blood collected at the delivery of 36 infants who were born to moms who got the Moderna or Pfizer/BioNTech vaccine while they were pregnant.
All but one of the moms was fully vaccinated at the time of their delivery. Every sample tested positive for the protective antibodies generated by the vaccine. The test could distinguish between antibodies generated by the vaccine and antibodies generated by a natural Covid-19 infection.
Those who were fully vaccinated during the second half of their pregnancies had the highest protective antibody levels. More research will be needed to determine if it’s better to get a shot in the second half of the pregnancy or earlier and to understand how long the protection lasts, but researchers believe this shows that newborns should be protected for the first few months of life.
Some context: This research was published online in the American Journal of Obstetrics & Gynecology-Maternal-Fetal Medicine.
An earlier study from some of the same researchers showed that the vaccines were safe for people who were pregnant and did not seem to increase any birth complications or increase the risk of miscarriage.
”High levels of transplacental antibody transfer are not surprising. It is consistent with what we see with other immunizations. Our findings add to a growing list of important reasons why women should be advised to receive the Covid-19 vaccine during pregnancy for the added benefit of their newborn receiving crucial protection,” Dr. Jennifer Lighter, the study’s senior author, said in a news release.
Lighter is an associate professor in the department of pediatrics and is a hospital epidemiologist at Hassenfeld Children’s Hospital at NYU Langone.
The US Centers for Disease Control and Prevention updated its guidance in August and recommended that all people 12 and older, including those who are pregnant, get the Covid-19 vaccine.
2:29 p.m. ET, September 22, 2021
Vaccine protection against Covid-19 wanes over time, especially for older people, CDC says
From CNN’s Maggie Fox
Michael Ciaglo/Getty Images
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. 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.
“We also saw declines, particularly for Pfizer, for 65 up, that we're not seeing in younger populations. Finally there's evidence of waning VE against hospitalization in the Delta period,” she said.
The CDC’s Advisory Committee on Immunization Practices is meeting to discuss the potential need for booster doses of vaccines, and is discussing vaccine effectiveness and safety in general. Pfizer has asked the US Food and Drug Administration to approve a booster dose of its vaccine for people 65 and older. FDA’s own vaccine advisers have recommended a booster only for 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.
Link-Gelles said that, overall, Moderna’s vaccine effectiveness is higher than the vaccine made by Pfizer/BioNTech. 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.
2:30 p.m. ET, September 22, 2021
Pfizer will continue to study how long vaccine protection lasts after third doses, company official says
From CNN's Jamie Gumbrecht
Patrick T. Fallon/AFP/Getty Images
Pfizer 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, a company official said Wednesday.
The conversation for now is focused on a third dose – a booster – of the company’s two-dose Covid-19 vaccine dose, a Pfizer official told the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
Experience with past vaccines suggests a third dose may provide longer, stronger protection, Pfizer Senior Vice President Dr. William Gruber told the committee. In that case, the primary series of the vaccine may works better as three doses, Gruber noted. But, he acknowledged, some experts believe protection is likely to drop again after a third booster dose.
“I think this is going to be driven largely by what we find in retrospect as we gather more information about protection, and we just need to stay tuned,” Gruber said.
Gruber said the company will continue to explore whether a longer interval between vaccine doses would work better; currently, the recommendation is 21 days between a first and second dose. He noted researchers in Europe and elsewhere have studied longer intervals, but the company’s focus has been maximizing protection as quickly as possible during the pandemic.
“We'll continue to explore whether or not it makes some sense to look at a longer interval,” Gruber said.
Pfizer is not studying the Pfizer vaccine as a booster for the Moderna or Johnson & Johnson vaccines, Gruber said, but it welcomes studies by others.
