The Food and Drug Administration (FDA) on Wednesday authorized updated COVID-19 booster shots specifically targeting a subvariant of omicron.
The move comes ahead of a fall campaign to give Americans booster shots, which is expected to launch in the coming days.
The move marks the first time the vaccines have been updated since the first shots were cleared at the end of 2020, and the updated shots are designed to catch up to evolutions in the virus.
The shots from Pfizer and Moderna target the omicron subvariants BA.4 and BA.5, as well as the original virus.
The shots can begin going into arms once the final step in the process, a Centers for Disease Control and Prevention committee, clears them, which is expected to occur on Thursday.
A major question, though, is how many people will actually want the new shots, given that uptake for the existing booster shots has lagged.
Only about half of people who got the first two shots received the initial booster dose.
“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19,” said FDA Commissioner Robert Califf. “As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants.”
Seeking to keep up with the ever-evolving virus, the FDA did not wait for the time-consuming process of going through full clinical trials on this tweaked vaccine. But it noted that it is highly confident that the vaccines are safe and effective. The agency pointed to the millions of doses of the original vaccines that have been given, as well as data from another version of the updated vaccine, along with preliminary data on this one.
Peter Marks, a top FDA vaccine official, compared the process to the annual updates to the flu vaccine that seek to adapt to the changes in that virus.
“The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization,” Marks said.
The updated Moderna vaccine is cleared for people 18 and older, and the Pfizer vaccine for people 12 and older.
For both, people are eligible for the booster shot of the updated vaccine if it has been at least two months since their last shot.
This week, the Food and Drug Administration (FDA) announced a change intended to stretch out the limited supply of monkeypox vaccine doses, allowing the shots to reach five times the number of patients. Monkeypox, a disease in the smallpox family, is spread primarily through skin-to-skin contact, often causing patients to develop painful lesions.
Although most cases resolve within a few weeks, the rapid growth in cases, now more than 9K domestically and 30K globally, is still a cause for concern, leading federal officials to declare a public health emergency last week. The FDA is also recommending that providers administer the vaccine between layers of skin, rather than below the skin into fatty tissue. This dosing change will allow providers to extend the nearly half a million doses not yet sent to states, in order to reach the more than 1.6M Americans considered highest risk.
The Gist: The country is now dealing with two public health emergencies from highly contagious diseases simultaneously. While monkeypox isn’t nearly as transmissible, deadly, or overwhelming to the healthcare system as COVID, the public health response has nonetheless been lackluster (and this week’s new COVID guidance suggests that the CDC has largely given up on managing the response, devolving responsibility to individuals in nearly all settings).
For those hoping that the COVID experience would spark faster action by our public health system, the federal response to monkeypox shows we haven’t applied the lessons learned. Public health authorities aren’t conducting rigorous disease surveillance, testing and treatments remain hard to get, and Congress isn’t dedicating funds for the response. The lack of proactive leadership is likely to result in healthcare providers again bearing the brunt of efforts to manage another unsuppressed viral outbreak.
Details: Department of Health and Human Services secretary Xavier Becerra made the announcement Thursday in a briefing on monkeypox.
Federal health officials can now expedite preventative measures to treat monkeypox without going through a full federal review, the Washington Post reports.
What they’re saying: “We’re prepared to take our response to the next level in addressing this virus,” Becerra said Thursday. “We urge every American to take monkeypox seriously and to take responsibility to help us tackle this virus.”
Dr. Rochelle Walensky, the director of the Centers for Disease Control and Prevention, said the declaration will help “exploit the outbreak” and potentially increase access to care for those at risk.
Dr. Demetre Daskalakis, the White House national monkeypox response deputy coordinator, said “today’s actions will allow us to meet the needs of communities impacted by the virus … and aggressively work to stop this outbreak.”
State of play: Dr. Robert Califf, the commissioner of the Food and Drug Administration, said the U.S. is “at a critical inflection point” in the monkeypox outbreak, requiring “additional solutions to address the rise in infection rates.”
There are 6,600 cases of monkeypox in the U.S. as of Thursday, Becerra said.
There were less than 5,000 cases of monkeypox last week, he added.
The big picture: Biden’s decision to declare monkeypox a public emergency allows him to raise awareness of the virus and unlock more flexibility for spending on ways to treat and tackle the virus.
About 20% of Americans are worried they’ll contract monkeypox, Axios previously reported. But there are still some gaps in Americans’ knowledge of the virus and how it impacts our population.
What’s next: U.S. health officials said that 800,000 monkeypox vaccine doses will be made available for distribution. But in hotspot states for the monkeypox outbreak, there’s a drastic disconnect between the number of doses that local health officials say they need versus what they have been allotted.
The U.S. will receive another 150,000 monkeypox vaccine doses in the strategic national stockpile in September, Dawn O’Connell, administrator at HHS’ Administration for Strategic Preparedness & Response, told reporters Thursday. These were previously scheduled to arrive in October.
The COVID-19 vaccine strategy for the fall remains beset with unanswered questions after an FDA expert panel on Tuesday spent hours debating how and whether to update the shots.
Why it matters: Time is running short to develop a game plan with existing vaccines losing effectiveness against new variants and more than half of Americans still without a booster dose.
Driving the news: The Vaccines and Related Biological Products Advisory Committee voted 19-2 to recommend an Omicron-specific update to COVID-19 booster vaccines expected to be rolled out within the next few months.
But key questions were left unanswered:
The panel didn’t formally decide whether to update shots with the prevalent Omicron strain in circulation, currently the fast-spreading BA.4 and BA.5 subvariants, or the BA.1 lineage that emerged late last year, as the World Health Organization recommended.
The consensus appeared to be for a bivalent, or combination, booster combining the original COVID-19 strain that emerged in late 2019 with BA.4 and BA.5.
The FDA will continue to evaluate what to do about the primary series of vaccines for the fall.
Experts were split on whether there was enough data to recommend the updated shots for kids, or whether more studies are needed on dosage and possible side effects.
There also were concerns about what effect an updated vaccine would have on developing nations’ willingness to use older COVID shots to inoculate their populations.
And above all, it’s unclear whether all the questions about who gets which shot when will add to public confusion and apathy that’s dogged the vaccination effort in recent months.
What they’re saying: “None of us has a crystal ball and we’re trying to use every last ounce of what we can from predictive modeling and data that’s emerging to try to get ahead of a virus that’s very crafty,” said top FDA vaccine regulator Peter Marks.
“Unfortunately, looking in the past doesn’t help us a great deal to look in the future for [a] virus that has baffled a lot of us and made predictions almost irrelevant,” said acting panel chairman Arnold Monto, a University of Michigan epidemiologist.
The timetable: Pfizer-BioNTech said an updated mRNA vaccine could be ready in October if regulatory uncertainties are ironed out. Moderna said it could have large amounts ready in late October or early November. Novavax is still awaiting emergency use authorization for its protein-based shot, but said it could have an updated vaccine by the fourth quarter.
A Pennsylvania physician accused of prescribing ivermectin and hydroxychloroquine to treat and prevent COVID-19 has been terminated from Tower Health, PennLive reported Feb. 4.
Edith Behr, MD, is allegedly linked to Christine Mason, a woman who used a Facebook account to connect people to a physician for hydroxychloroquine and ivermectin prescriptions. A social media user claimed Dr. Behr was the source of the prescriptions and reported her to authorities and her employer, according to PennLive.
West Reading, Pa.-based Tower Health officials became aware of the allegations against Dr. Behr Feb. 2 and took immediate action.
“Tower Health became aware yesterday of the allegations involving Dr. Edith Behr prescribing ivermectin and hydroxychloroquine for the treatment of COVID-19,” Tower Health said in a Feb. 3 statement to PennLive. “We investigated the matter and, as a result, Dr. Behr’s employment with Tower Health Medical Group has been terminated effective immediately.”
Dr. Behr was a surgeon at Phoenixville (Pa.) Hospital, which is owned by Tower Health, according to the report.
Ivermectin and hydroxychloroquine have not been approved by the FDA for prevention or treatment of COVID-19.
What they’re saying: “The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” acting FDA Commissioner Janet Woodcock said in a statement.
“The totality of real-world data and the full [Biologics License Application] for Spikevax in the United States reaffirms the importance of vaccination against this virus,” Moderna CEO Stéphane Bancel said.
The big picture: The rise of the Omicron variant forced vaccine makers to reevaluate the effectiveness of their vaccines, which were developed based on eaarlier forms of the virus.
Studies show that Moderna and Pfizer-BioNTech’s vaccines still overwhelmingly prevent severe disease and hospitalizations, especially when the first two doses are reinforced with a booster shot.
Merck antiviral drug molnupiravir received emergency authorization, joining Pfizer’s Paxlovid as the only authorized oral antiviral drugs for treating Covid-19. Though the Merck and Pfizer antivirals appear to work against the omicron variant, FDA officials stressed that these drugs are authorized only for certain patients and they are not a substitute for vaccination.
Merck’s oral antiviral drug molnupiravir now has FDA emergency use authorization for treating mild-to-moderate Covid-19, a Thursday decision that comes one day after the regulator authorized use of a pill from Pfizer. The FDA actions come as the highly infectious omicron variant becomes the dominant strain of the novel coronavirus, fueling a rise in Covid-19 cases that is pushing hospitals to capacity across the country.
The Merck and Pfizer antivirals both work by interfering with the virus’s ability to replicate, though in different ways. Molnupiravir introduces errors into the genetic code of SARS-CoV-2, while Paxlovid targets a key viral enzyme called main protease. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said both drugs should work against omicron.
“The available data that we have indicate that both Paxlovid and molnupiravir are effective against omicron,” Cavazzoni said, speaking during a Thursday morning media briefing. “Both drugs interfere with aspects of the virus’s replication apparatus, and that apparatus is preserved across variants.”
Molnupiravir’s authorization, which comes three weeks after an FDA advisory committee meeting for the drug, covers its use in adults diagnosed with Covid-19 who are at a high risk of their disease progressing to hospitalization or death. The Merck drug is to be used when other treatment options are not accessible or appropriate. It can only be prescribed to those 18 and older because the drug can affect bone and cartilage growth.
Authorized use of Pfizer’s antiviral, Paxlovid, extends to pediatric patients. The FDA’s guidelines state the drug may be used for treating Covid-19 patients 12 and older weighing at least 40 kg (about 88 pounds). The FDA did not convene an advisory meeting for the Pfizer drug. John Farley, director of FDA’s Office of Infectious Diseases, said there were no pressing scientific questions about Paxlovid that would benefit from an advisory committee discussion.
Both molunupiravir and Paxlovid are available only by prescription. The FDA said treatment with these drugs should begin as soon as possible after a positive Covid-19 diagnosis, and within five days of the start of symptoms. These drugs aren’t for patients who are already hospitalized. Earlier this year, Merck stopped testing molnupiravir in those who are hospitalized after an early look at Phase 2 trial data indicated that the drug was unlikely to help these patients.
Authorization of Merck’s antiviral is based on a placebo-controlled clinical trial enrolling non-hospitalized adults with Covid-19 who were at high risk of progressing to severe disease or hospitalization. These higher risk patients include those who have a chronic medical condition or those who had not or could not receive a Covid-19 vaccine. The main goal was to measure the percentage of people hospitalized or dead from any cause during the 29 days after the course of treatment. The FDA said that of the 709 people in the study who received molnupiravir, 6.8% were hospitalized or died. By comparison, 9.7% of the 699 people given a placebo were hospitalized or died. During the follow-up period, one patient treated with molnupiravir died compared to nine of those given a placebo. Side effects reported include diarrhea, nausea, and dizziness.
In the clinical trial for Pfizer’s antiviral, Paxlovid led to an 88% reduction in Covid-19-related hospitalization or death from any cause compared to placebo. Of the 1,039 patients treated with Paxlovid, 0.8% of patients were hospitalized or died during the 28-day follow-up period, compared to 6% of those given a placebo.
Farley said that patients should consult with their physician to determine the best treatment. While molnupiravir is indicated for those who don’t have other treatment options, there are some groups of patients in which Paxlovid would not be appropriate. Examples include patients taking other medications that could interact with the Pfizer drug, Farley said. Paxlovid is also not recommended for patients who have severe kidney problems or cirrhosis of the liver. The key feature of both drugs is that they are oral, which enables patients to take these medication at home. Authorized antibody therapies from Regeneron, Eli Lilly, partners Vir Biotechnology and GlaxoSmithKline, and Roche, are infusions that must be administered in a clinical setting.
Patients take Merck’s molnupiravir as four pills, twice a day. Patients prescribed Pfizer’s Paxlovid must take more pills. The drug is taken with ritonavir, a drug that slows the breakdown of Paxlovid and helps it remain in the body for a longer period of time. Dosing of the Pfizer drug requires two tablets of Paxlovid and one of ritonavir, twice daily. The duration of treatment for both the Merck and Pfizer antivirals is five days.
1. While “vaccination” briefly appeared onscreen in a list of options, it didn’t merit a mention in the video.
2. The surgeon general listed guidance on “emerging” treatments that was … remarkably on point.
The absence of focus on vaccines in the video is unfortunate, if entirely in keeping with the GOP’s willingness to play to its anti-vax base. That’s bad, but not surprising.
What was surprising was No. 2. The information Ladapo shared about treatments was fairly accurate. In the video, he told Floridians to ask their doctor about monoclonal antibodies, fluvoxamine, and inhaled budesonide should they come down with Covid-19.
I’ve been reporting on the Covid-19 treatment beat for much of this year, and I’ve uncovered a massively confusing pile of contradictory information. But those are the top three treatments I’d recommend sick loved ones talk to doctors about, and while there’s much we still don’t know, solid science suggests they have real promise.
That said, the fact that such important (and accurate) information stood out in a government PSA indicates just how dismal the state of public communications on treatments is — and just how much misinformation and distrust are hampering the fight against Covid-19.
What should you take if you get Covid-19?
There’s been little public health communication about which treatments to pursue if you get Covid-19, perhaps because for much of the pandemic, it’s been unclear what options are better for mild Covid than just resting at home. While in 2021 the best treatment recommendations have gotten clearer, public health messaging over the last year has rightly been focused on vaccination.
The official CDC page on what to do if you get sick with Covid-19 advises you to wear a mask, wash your hands, and clean high-touch surfaces to avoid infecting those around you. If your breathing deteriorates or you show signs of severe illness like confusion or an inability to stay awake, the CDC advises you to go to the hospital.
All sound guidance — but what it doesn’t offer is advice on a question that patients who aren’t sick enough for hospitalization might desperately need to know: What medication should I take if I come down with Covid-19?
Meanwhile, large, high-quality, peer-reviewed, and published randomized controlled trials (RCTs) have found promise for cheap therapies that are already FDA approved for other purposes and have an established safety profile.
Research underway will help provide a better understanding of both of these therapies, but there’s enough evidence that some doctors are already prescribing them to patients. If you have the opportunity to enroll in an ongoing clinical trial of these medications, you can get access to a potentially promising treatment and help contribute to our scientific understanding of whether these treatments really work.
Another exciting treatment in the pipeline is Paxlovid, an antiviral developed by Pfizer that showed impressive 90 percent efficacy in preventing hospitalization — so effective that in November, the clinical trial stopped enrolling new participants because investigators concluded it’d be unethical to put them in the control group. It has not yet been approved by the FDA, but it might be a game changer if, as is expected, it’s approved in January.
Why is it so hard to find good guidance about treatments?
The US government has communicated little about Covid-19 treatment options. NIH guidelines about treatments like fluvoxamine haven’t been updated since this past spring, meaning results from recent high-quality studies haven’t been incorporated into that guidance. Without it, physicians considering whether to prescribe these medications can’t turn to official public health resources for help.
From a certain perspective, that reticence is understandable. Learning which Covid-19 treatments work is very hard. While large-scale RCTs found promising evidence for fluvoxamine and inhaled budesonide, “promising” is still the most we can say — it could absolutely turn out that the real-world effects are much smaller than hoped for, or even fail to materialize altogether.
But it’s precisely because this area is so difficult to navigate for doctors and patients that the CDC, FDA, and NIHcould play an important role in pointing out good treatments — yet it’s a role they have been puzzlingly reluctant to play.
Perhaps because of the dearth of formal federal government guidance on treatments — and because of politically driven crazes over drugs like hydroxychloroquine and ivermectin, which evidence thus far suggests do little to fight Covid-19 — Florida media hasbeencritical of Ladapo’s PSA and its recommendations.
But that justified irritation shouldn’t get in the way of a needed conversation about the possible benefits and drawbacks of monoclonal antibodies, fluvoxamine, and budesonide. As the US braces for an omicron surge that is likely to hit even vaccinated people, effective treatment is going to be essential for saving lives. Yes, promoting vaccines is a must, but tens of thousands of Americans are getting sick each day, which makes clear, accurate communication about which treatments to ask your doctor about extremely important.
The more society and public health get aligned on what works, the better off we’ll be in confronting omicron and other future variants.
Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Sunday said vaccine developers have “a pretty good degree of confidence” that fully vaccinated individuals who have received a COVID-19 booster are protected against the omicron variant.
Appearing on CBS’s “Face the Nation,” Gottlieb said that there is no indication that the omicron variant first detected in South Africa makes individuals more ill than other previously detected variants, and that there have been anecdotal accounts of people experiencing mild cases of COVID-19, though he pointed out that initial cases appear to have been clustered among young people.
“The question here is going to be whether or not a fully boosted individual someone who’s had three doses of vaccine has good protection against this variant right now,” said Gottlieb, who now sits on Pfizer’s board of directors.
“If you talk to people in vaccine circles, people who are working on a vaccine, they have a pretty good degree of confidence that a boosted vaccine, so three full doses of vaccine, is going to be fairly protective against this new variant,” said Gottlieb.
However, Gottlieb stressed that data on the omicron data is sparse, with no clinical studies or test tube studies having been completed. He estimated that studies testing the blood of vaccinated people against the omicron variant could be out by the end of this week or some time next week.
“Now, I would expect that those studies are going to show that the neutralization against this virus declined substantially. But that doesn’t mean that the vaccines won’t be effective,” he said.
Federal officials waited months before making all American adults eligible for a COVID-19 booster shot — meaning millions of Americans may not have the strongest possible protection as they head into holiday travel.
Why it matters: Critics say the confusing process undermined what has now become a critical effort to stave off another wave of the pandemic.
Most vaccinated people, even without a booster, still have very strong protection against serious illness or death. But a third shot drastically increases people’s defenses against even mild infections, which could in turn help reduce the virus’ spread.
And some vulnerable vaccinated adults are at risk of serious breakthrough cases.
What they’re saying: “We have a consensus. Boosters are very important in maintaining people’s defenses against COVID. We need to get as many people vaccinated and boosted [as possible] as the winter sets in,” David Kessler, the chief science officer of Biden’s COVID response, said in an interview.
Context: Preliminary data released months ago suggested a significant decline in the vaccines’ effectiveness at preventing infection, although they held up well against severe disease.
Based on that data, the Biden administration had hoped to begin allowing booster shots in September for any American adult who was at least eight months removed from their second dose.
The CDC and the FDA opted instead to only authorize boosters for seniors, people with high-risk medical conditions and people at high risk of infection, before opening them last week to everyone at least six months out from their initial shots.
In the meantime, red and blue states alike decided to ignore the CDC and open up booster eligibility on their own, and breakthrough infections have become increasingly common.
Millions of people who weren’t technically eligible for boosters got them anyway, and a large portion of the most vulnerable patients still haven’t gotten one.
Where it stands: Only 41% of vaccinated Americans 65 and older have received a booster shot, as have 20% of all vaccinated adults, per the CDC.
“Some of us were there several months ago. Some wanted more data. In the end, there’s a convergence of opinions. It’s the way an open scientific public health process should work,” Kessler said.
Between the lines: The U.S. drug approval process — with its insistence on high-quality data and careful expert reviews — is the world’s gold standard precisely because it moves deliberately. Regulators have been trying this whole time to figure out how to adapt that system to a fast-moving pandemic.
Some federal officials, as well as many outside experts, said there wasn’t enough data to make a broad booster recommendation earlier this fall.
Early on, many public health experts also argued that it was unethical to give Americans a third shot while much of the rest of the world awaited their first shots.
Israel embraced boosters before the U.S. beginning over the summer, and its emerging data has been key to making the case that boosters are needed and can help bring surges under control. However, experts still don’t know how long the enhanced protection they give will last.
What they’re saying: “Some argued early on that the primary series was good enough and we should conserve doses for the world. What’s emerging is that all people in the world are going to need to be boosted,” a senior administration official said.
“Everyone has a different threshold for how much data they need in making a decision,” the official added. “What made this different is that there’s a pandemic underway, and many saw we were heading into a winter surge.”