FDA approves updated COVID-19 vaccines for upcoming fall and winter season
(SILVER SPRING, Md.) — The U.S. Food and Drug Administration approved and granted emergency use authorization Thursday for updated COVID-19 vaccines for the upcoming fall and winter season.
The FDA said the vaccines will target the KP.2 strain, which is an offshoot of the omicron variant.
The federal health agency said the decision applies to the vaccines manufactured by Pfizer-BioNTech and Moderna. No decision has been made on the vaccines from Novavax.
“Vaccination continues to be the cornerstone of COVID-19 prevention,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement. “These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality.”
“Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variant,” the statement continued.
The CDC previously recommended that everyone ages 6 months and older receive an updated vaccine. The updated vaccines from Pfizer-BioNTech and Moderna will be available for those 6 months old and older
Vaccine manufacturers told ABC News the vaccines are expected to be available in the coming week.
Winter months tend to see an increase of respiratory illness spread, including COVID, flu and RSV. COVID, particularly, typically spikes in the winter and summer months.
“These updated COVID-19 vaccines come at a crucial time as we head into the fall and winter months, when respiratory viruses tend to surge,” said Dr. John Brownstein, an epidemiologist and chief innovation officer at Boston Children’s Hosptial and an ABC News contributor. “By targeting the most currently circulating variants, these vaccines offer us a better chance at reducing severe illness and keeping communities safe.”
The CDC has said that it is safe to receive a COVID-19 vaccine at the same time as a flu shot or an RSV vaccine, for those who are being eligible.
Anyone who has recently had COVID, may want to consider delaying getting vaccinated by three months, according to the CDC.
Those who are covered by Medicare, Medicaid or private insurance will receive coverage for the updated vaccines.
In previous years, the CDC had a Bridge Access Program that provided free COVID-19 vaccines to adults without health insurance and adults whose insurance does not cover all COVID-19 vaccine costs. The program is ending in August 2024. It remains unclear what might be available to provide access to this population.
Unvaccinated children from ages 6 months through 4 years are eligible to receive three doses of the Pfizer vaccine or two doses of the Moderna vaccine. Children in this age group who are vaccinated are eligible to receive one or two doses of either vaccine.
Those who are 5 and older, regardless of vaccination status, are eligible to receive a single dose of the updated vaccine. If they have been previously vaccinated, it should be at least two months after the last dose.
The FDA said additional doses are authorized for certain immunocompromised individuals aged 6 months through 11 years.
“It’s important for everyone aged six months and older to consider getting this updated shot. We know that that immunity wanes over time, and staying up to date with vaccinations is the best way to maintain strong protection against COVID-19, especially with new variants emerging,” Brownstein said.
ABC News’ Youri Benadjaoud contributed to this report.
(NEW YORK) — A New Hampshire resident died after being infected with a rare mosquito-borne disease, health officials said Tuesday.
The resident, an adult from Hempstead — near the southeastern border with Massachusetts — had tested positive for Eastern Equine Encephalitis virus (EEEV). The patient was hospitalized due to severe central nervous system disease and died of their illness, according to an update from the state’s Department of Health & Human Services (DHHS).
This is the first reported human case of EEEV in New Hampshire in a decade after three people contracted the disease in 2014, two of whom died, DHHS said.
It’s unclear when the resident, who recently passed away, first became infected with EEEV. No other details were available including name, age or sex.
In addition to the person infected with EEEV, the virus has also been found in one horse and seven mosquito batches in New Hampshire so far this summer, according to the health department.
Neighboring states have been experiencing similar threats. In Massachusetts, 10 communities were designated as being under high or critical risk of the virus, according to the state’s Department of Public Health. Many of the areas began implementing targeted mosquito spraying to protect residents.
“In New Hampshire, mosquitos transmit infections including Eastern Equine Encephalitis Virus, West Nile Virus, and Jamestown Canyon Virus,” Dr. Benjamin Chan, New Hampshire’s state epidemiologist, said in a statement.
“We believe there is an elevated risk for EEEV infections this year in New England given the positive mosquito samples identified. The risk will continue into the fall until there is a hard frost that kills the mosquitos. Everybody should take steps to prevent mosquito bites when they are outdoors,” the statement continued.
EEEV is a rare but serious disease that spreads by bites from infected mosquitoes. It does not spread via touching or droplets from coughing or sneezing, according to the Centers for Disease Control and Prevention (CDC).
Most people who are infected either show mild symptoms or no symptoms at all. However, severe cases usually begin with fever, headache, chills and vomiting before progressing to encephalitis, which is swelling of the brain, or meningitis, which is swelling of the membranes that surround the brain and spinal cord.
Many survivors have ongoing neurologic problems including convulsions, paralysis and intellectual disability, and about 30% of encephalitis cases from this virus result in death.
There are no human vaccines and no treatments specifically for EEEV. The CDC says rest, fluids and over-the-counter pain medications may help relieve some symptoms.
As of Tuesday, four cases have been reported aside from the New Hampshire case — with one case each in Massachusetts, New Jersey, Vermont and Wisconsin, according to the CDC.
The New Hampshire DHHS said residents can protect themselves by using effective mosquito repellents, wearing long-sleeve shirts and long pants when outside and avoiding outdoor activities when mosquitoes are the most active, including early in the morning and during evening hours.
Additionally, residents are advised to remove standing water from around their homes, which attracts mosquitoes, and to make sure doors and windows have tight-fitting screens.
(WASHINGTON) — Former New York Gov. Andrew Cuomo is set to publicly testify Tuesday before Congress on his administration’s nursing home policies during the early days of the COVID-19 pandemic.
The hearing, before the Republican-led House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic, will see Cuomo defend his decision to allow COVID-19-positive patients back into nursing homes and long-term care facilities while the pandemic was underway.
Cuomo previously testified before the subcommittee during a closed-door hearing in June. Transcripts from that interview, as well as with high-ranking officials during Cuomo’s administration, will be released ahead of the public hearing.
“Andrew Cuomo owes answers to the 15,000 families who lost loved ones in New York’s nursing homes during the COVID-19 pandemic,” subcommittee Chairman Rep. Brad Wenstrup, R-Ohio, said in a statement last week. “On September 10, Americans will have the opportunity to hear directly from the former governor about New York’s potentially fatal nursing home policies.”
In March 2020, as COVID-19 cases were surging, Cuomo issued an order requiring nursing homes to readmit all residents who were “medically stable” and returning after being hospitalized for the virus.
“No resident shall be denied re-admission or admission to the [nursing home] solely based on a confirmed or suspected diagnosis of COVID-19,” the order read.
It further stated that nursing homes were “prohibited from requiring a hospitalized resident who is determined medically stable to be tested for COVID-19 prior to admission or readmission.”
At the time, Cuomo explained that the order would help expand hospital capacity to meet the demands of caring for the sickest COVID-19 patients. After facing criticism from nursing home advocates, however, the governor amended the order in May 2020, prohibiting hospitals from discharging patients to nursing homes unless they first tested negative for COVID-19.
Cuomo fought back against criticism of his policies and, in July 2020, a report from the New York State Department of Health (NYSDOH) stated that COVID-19 was introduced into nursing homes by infected staff, and that peak staff infections correlated with peak nursing home resident deaths. The report also found that “admissions policies were not a significant factor in nursing home fatalities.”
However, in January 2021, New York Attorney General Letitia James released a report that found the NYSDOH had undercounted the number of nursing home residents who died of COVID-19 by as much as 50%, and failed to count in its official death tally nursing home residents who died of COVID-19 after being admitted to hospitals.
In 2022, Cuomo’s representative said the Manhattan District Attorney’s office would not file criminal charges in connection with the former governor’s handling of nursing home deaths during the pandemic.
Earlier this year, an independent investigation, commissioned by current New York Gov. Kathy Hochul, found that although Cuomo’s nursing home response policy was based on “the best available data at the time,” communication to the public was poor and caused anxiety for family members of nursing home residents.
“Even the most well-intentioned policy had unforeseen consequences in [New York state] nursing homes,” the report read.
(WASHINGTON) When Congress passed the Inflation Reduction Act in 2022, there was a key provision that the Biden administration fought hard for. For years, private insurance companies negotiated with drug makers over prescription prices.
However, Medicare, representing 50 million seniors, did not have the same right to negotiate prices for its Part D coverage. This meant that Medicare basically had to accept the prices offered to them.
Health and Human Services Secretary Xavier Becerra joined “Start Here,” ABC News’ flagship daily news podcast, earlier this year to announce that negotiations were starting. They had selected 10 medications to prioritize and attempt to bargain down prices.
On Thursday, during the first public event held by President Biden and Vice President Harris since the Biden dropped out of the presidential race, they revealed that they had agreed on all issues. This is being described as a significant development for anyone on Medicare, and for anyone who pays taxes to fund the expenses of Medicare.
Secretary Becerra joined “Start Here” on Friday to discuss this further.
START HERE: Mr. Secretary, last time we spoke you had just identified the drugs…they included some diabetes drugs, some arthritis medications, treatments for blood clots and blood cancer. Where are we now?
BECERRA: We are done with the negotiation, Brad. We have completed 10 drugs. Every company joined in the negotiations. We had offers, counter offers, and we hit a sweet spot with all ten. And that sweet spot will save Americans on Medicare who need these drugs lots of money. And it will save taxpayers who help fund the Medicare program lots of money, in the billions.
START HERE: Yeah. How much of a discount are we talking about here?
BECERRA: So in some cases, the discount from the list price is up to 79%. I think the lowest discount is about 38%. And I do want to caveat that a bit. Very rarely does anybody pay list price for anything. And if you do, take it back and bargain a bit. Whether it’s that car at the dealership where you look at list price, you don’t pay that. When you go to the department store, you try to find everything you can on sale or, you know at some point it’s going to go on sale.
And so everybody makes the effort to try to get the best price for whatever the product is. In this case, it’s a very important product, it’s your prescription medication. But you should still be able to get a good price, and that’s what we did. We negotiated and got a much better price than what Medicare was getting.
START HERE: But just so we can we can be clear about that caveat. You’re saying it’s 68%, say it’s like 79% less than the list price. But you guys weren’t paying the list price earlier. Can you tell us how much you were paying on these drugs beforehand, and how much the new discount you’ve gotten is?
BECERRA: Yeah. And that’s where it gets a little dicey because there are lots of nooks and crannies in the health care system. Some of them include what are, what is considered proprietary information of the companies, the drug companies, that they don’t want disclosed. And so the net price that Medicare pays is lower than the list price, but still high.
START HERE: So there’s some contract somewhere being like “You guys, no one can disclose what you guys had originally been paying.”
BECERRA: Yeah. We can’t, we can’t take you behind the curtain unless the drug companies tell us it’s okay to do so.
START HERE: Were you able to actually push back against these drug companies, or was it kind of like “We’ll ask once and then we’ll have to take what we get. We’re not going to risk not giving Americans these, these drugs.”
BECERRA: Well, let’s just say that when they came in with their offer or counteroffer, the final price was neither our initial offer nor their official offer. But here’s what I will tell you. The Congressional Budget Office, which is Congress’ budget estimator, they’re the ones that keep tabs of what legislation will cost — will it save money or will it cost taxpayers money? And they are very stingy when it comes to saying “Oh, taxpayers will save money.” Right?
Well, the Congressional Budget Office said with regard to the Inflation Reduction Act and prescription drug negotiation, they said, we believe in the first year of negotiation — which we just finished — in that first year, and they’re projecting because they didn’t know which drugs it would be, etc.. They said, we believe the Department of Health Human Services will save $3.7 billion. Well, we’ve saved $6 billion.
And on top of that, we’re saving people out of pocket another billion and a half. But here’s the kicker. They said over 10 years, they assume that this new law, over 10 years of negotiating, will save $100 billion. So if we’re already almost double their first estimate for their first year, I guarantee you we’re going to do better than the 100 billion, over 10 years.
START HERE: Okay. When do the new prices go into effect, then I guess?
BECERRA: Jan. 1, 2026.
START HERE: Okay, so when that kicks in, how much of a discount will average Medicare patients actually see? Because, like, if you guys scored a 68% discount on Farxiga, like the diabetes kidney medication, does that mean that the person using that drug is going to pay, it doesn’t mean they’re going to pay 68% less. I mean, how much less would it be?
BECERRA: Yeah. So remember, and that’s also a difficult question because seniors don’t typically pay very much for their prescription medication. Medicare the program, that’s the beauty of Medicare, it covers the lion’s share of the cost of those drugs. Some Americans still have to pay some out-of-pocket costs for their drugs, especially the higher cost drugs. So we’re going to save folks quite a bit of money.
Let’s put it this way: I can talk to you in total aggregate terms. We can now look at the price that we negotiated and say “Okay, if we had this price back in 2023, what would our cost have been?” And the result is we would have saved $6 billion to the health care program, and Americans will be able to save about a billion and a half dollars collectively in their out-of-pocket costs.
START HERE: The trade group that represents companies like Pfizer, Lilly, Merck, they’ve said we might not see as much innovation because we’re not getting as much money. That’s, that’s constantly been sort of a critique of this. They also say that your math makes assumptions about how many people truly save money on this. They say a very small amount of people actually get this Part D plan in the way that would actually save the money here. What is your response to to to these pharmaceutical groups?
BECERRA: Well, remember, they’re more than 50 million Americans who have prescription coverage under Medicare, the Part D program. There are about 9 million people in the Medicare program who use one of these 10 drugs. It’s not a small universe of people. And these are very expensive drugs. When you can bring the price down of a drug that’s listed for, say, $10,000, $12,000 to $3,000. That’s a pretty good deal. It’s still $3,000, but it sure saved you a ton of money. If you were paid $12,000 or 13,000 before that.
And so this will save not just the Medicare program money, but it will save Medicare beneficiaries money. And it certainly will pay taxpayers who today, when they work, have some of their money from their paycheck taken out so they could cover their Medicare investment into the future so that when they get turned 65, they can qualify. They will get to benefit from a strengthened Medicare program that will have those new resources available, because we didn’t have to spend it at, for overcharging us for the prescription medication.
START HERE: Well, so now, I mean, the idea is that you’ll negotiate more drug prices, right? So you got these 10 out of the way. What are the next 10 or the next 20, or do you guys have a sense of what types of drugs you’re looking to target?
BECERRA: Yeah. And here I have to be careful, because everything we say about a drug can move the price on the market. Right? And I don’t want to be accused of trying to influence the price up or down. And so what I can tell you is the statute, the new law, the Inflation Reduction Act, gave a pretty clear prescription of how to select these, set of drugs that will be negotiated. That’s a, it’s a good thing in the way, in a sense that it doesn’t let politics enter into this. It was pretty clear which drugs count. In this case, the first 10, they had to be the most expensive drugs in the Medicare system.
START HERE: All right. So then we’ll see what happens next. All right. Secretary Xavier Becerra, thank you so much.