(WASHINGTON) — President Joe Biden on Wednesday relaunched the federal government’s cancer “moonshot” initiative, with the goal of cutting the death rate from cancer in half over the next quarter-century.
“We can end cancer as we know it,” Biden said during an event at the White House.
The initiative is personal for Biden, who lost his son Beau to brain cancer in 2015 and who first launched the initiative as vice president.
“I committed to this fight when I was vice president,” Biden said Wednesday. “It’s one of the reasons why quite frankly why I ran for president. Let there be no doubt, now that I am president, this is a presidential, White House priority. Period.”
After the Obama presidency, Biden and wife — and now first lady — Jill Biden founded a nonprofit foundation dedicated to finding a cure for cancer.
In 2016, Congress authorized $1.8 billion in funding for the government’s moonshot initiative over seven years. There’s $410 million left for the next two fiscal years.
In addition to cutting today’s age-adjusted death rate from cancer by at least 50% over the next 25 years — after it has fallen by about 25% over the past 20 years — the initiative will aim to “improve the experience of people and their families living with and surviving cancer,” the White House said.
“It’s bold,” Biden said. “It’s ambitious. But it’s completely doable. Just as we harnessed the size to develop cutting edge COVID-19 vaccines and treatments, we’ll bring a fierce sense of urgency to the fight against cancer.”
On Wednesday, Biden said he was “announcing a call to action for cancer screening and early detection.”
More than 9.5 million cancer screenings were missed in the U.S. because of the COVID-19 pandemic, the White House said.
“We have to get cancer screenings back on track,” Biden said. “And make sure they’re accessible to all Americans.”
But the pandemic has also led Biden to set “very ambitious goals,” a senior Biden administration official told reporters Tuesday.
“The scientific advances that we saw from the COVID-19 pandemic, from the response to it, also points to things that are possible today,” the official said.
One example, according to the White House, is that the relaunched initiative will aim to “study and evaluate multi-cancer detection tests, like we did for COVID-19.”
The cancer “moonshot” initiative will have a coordinator in the White House, and the White House will form a “cancer cabinet” of officials from across the federal government. The initiative will involve the private sector, foundations, academic institutions and others, too.
Other goals, according to the White House, include increasing equitable access to screening and prevention — with at-home screening, mobile screening, and community health networks, as well as “accelerating efforts to nearly eliminate cervical cancer through screening and HPV vaccination, with a particular focus on reaching people who are most at risk.”
There will be a White House cancer “moonshot” summit, as well as a White House roundtable conversation series, they said.
The president also called on Congress to approve funding for a research project he has proposed to be housed at the National Institutes of Health, called “Advanced Research Projects Agency for Health (ARPA-H),” which would try to develop breakthroughs for several diseases.
Biden was joined Wednesday in the White House’s East Room by about 100 members of the cancer community, including patients, survivors, researchers, advocates, caregivers, members of Congress and others, according to senior Biden administration officials.
During his remarks, the president drew on his own family’s experience navigating a cancer diagnosis, articulating many of the challenges people around the country face after hearing they have cancer.
“Despite all the progress,” Biden said, “there’s still a sense of powerlessness, guilt that maybe you’re not doing enough because you don’t know enough.”
The first lady and Vice President Kamala Harris. whose mother was a breast cancer researcher, also spoke.
(WASHINGTON) — President Joe Biden on Wednesday will relaunch the federal government’s cancer “moonshot” initiative, with the goal of cutting the death rate from cancer in half over the next quarter-century, according to the White House.
The initiative is personal for Biden, who lost his son Beau to brain cancer in 2015 and who first launched the initiative as vice president.
After the Obama presidency, Biden and wife — and now first lady — Jill Biden founded a nonprofit foundation dedicated to finding a cure for cancer.
In 2016, Congress authorized $1.8 billion in funding for the initiative over seven years. There’s $410 million left for the next two fiscal years.
In addition to cutting today’s age-adjusted death rate from cancer by at least 50% over the next 25 years — after it has fallen by about 25% over the past 20 years — the initiative will aim to “improve the experience of people and their families living with and surviving cancer,” the White House said.
“Taken together, these actions will drive us toward ending cancer as we know it today,” the White House said.
On Wednesday, Biden and the first lady will also announce “a call to action on cancer screening to jumpstart progress on screenings that were missed as a result of the pandemic, and help ensure that everyone in the United States equitably benefits from the tools we have to prevent, detect and diagnose cancer,” according to the White House.
More than 9.5 million cancer screenings were missed in the U.S. because of the COVID-19 pandemic, the White House said.
But the pandemic has also led Biden to set “very ambitious goals,” a senior White House official told reporters Tuesday.
“The scientific advances that we saw from the COVID-19 pandemic, from the response to it, also points to things that are possible today,” the official said.
One example, according to the White House, is that the re-launched initiative will aim to “study and evaluate multi-cancer detection tests, like we did for COVID-19.”
The cancer “moonshot” initiative will have a coordinator in the White House, and the White House will form a “cancer cabinet” of officials from across the federal government. The initiative will involve the private sector, foundations, academic institutions and others, too.
Other goals, according to the White House, include increasing equitable access to screening and prevention — with at-home screening, mobile screening, and community health networks, as well as “accelerating efforts to nearly eliminate cervical cancer through screening and HPV vaccination, with a particular focus on reaching people who are most at risk.”
There will be a White House cancer “moonshot” summit, as well as a White House roundtable conversation series, they said.
On Wednesday, Biden will speak at an event in the White House’s East Room, joined by about 100 members of the cancer community — patients, survivors, researchers, advocates, caregivers, members of Congress and others — according to a senior administration official. The first lady and Vice President Kamala Harris (whose mother was a breast cancer researcher) will also make remarks, the official said.
(WASHINGTON) — Nearly two years into the coronavirus pandemic, children ages 5 and under are one step closer to being eligible to be vaccinated against COVID-19.
Pfizer on Tuesday asked the U.S. Food and Drug Administration for emergency use authorization of its COVID-19 vaccine for kids ages 6 months to 5 years old.
The FDA will now review the data, bring it before its expert advisers and potentially authorize the vaccine in the coming weeks before sending it to the Centers for Disease Control and Prevention for final approval.
“Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants,” Pfizer CEO Albert Bourla said in a statement. “If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose.”
Here are nine questions answered about the COVID-19 vaccines and kids as families seek to make the best decisions.
1. What is the science behind the COVID-19 vaccine?
Both the Pfizer and Moderna vaccines use mRNA technology, which does not enter the nucleus of the cells and doesn’t alter human DNA. Instead, it sends a genetic “instruction manual” that prompts cells to create proteins that look like the outside of the virus — a way for the body to learn and develop defenses against future infection.
The Johnson & Johnson vaccine uses an inactivated adenovirus vector, Ad26, that cannot replicate. The Ad26 vector carries a piece of DNA with instructions to make the SARS-CoV-2 spike protein that triggers an immune response.
This same type of vaccine has been authorized for Ebola and has been studied extensively for other illnesses and for how it affects women who are pregnant or breastfeeding.
Neither of these vaccine platforms can cause COVID-19.
2. What is the status of vaccine eligibility for kids?
Children ages 5 and older are now eligible to receive Pfizer’s two-dose vaccine.
Children ages 12 to 15 are also eligible to receive a Pfizer vaccine booster shot.
Pfizer has submitted data to the FDA for a two-dose vaccine for kids under five, with the expectation that data will soon be available to make it a three-dose vaccine, which will likely be more effective. The company announced in December that it would amend its ongoing clinical trials for children under age 5 to add a third dose.
The two other vaccines currently available in the U.S., Moderna and Johnson & Johnson, are currently available only for people 18 years and older.
Moderna filed for emergency use authorization with the FDA for its vaccine in adolescents in June but is still awaiting a decision.
Johnson & Johnson announced in April that it had begun vaccinating a “small number of adolescents aged 16-17 years” in a Phase 2a clinical trial.
As of April, the trial was enrolling participants only in Spain and the United Kingdom, with plans to expand enrollment to the U.S., the Netherlands and Canada, followed by Brazil and Argentina.
3. Why do kids need to be vaccinated against COVID-19?
While there have not been as many deaths from COVID-19 among children as adults, particularly adults in high-risk categories, kids can still get the virus and they can also transmit the virus to adults.
A total of 11.4 million children have tested positive for the virus since the onset of the pandemic. Child COVID-19 cases have “spiked dramatically” during the omicron variant surge, with more than 3.5 million child cases reported in January.
According to the CDC, unvaccinated 12- to 17-year-olds had an 11 times higher risk of hospitalization than fully vaccinated adolescents.
“We know that COVID does not spare kids,” ABC News medical contributor Dr. John Brownstein, an epidemiologist and chief innovation officer at Boston Children’s Hospital, said in December. “Maybe it’s less severe than their adult counterparts but we also know that the virus has had real significant impacts on morbidity and mortality in kids.”
“We also know that kids play an important role as vectors of spread,” he said. “And especially in light of increases we’re seeing right now, with increases of cases in kids in record numbers, infections among kids further perpetuate community transmission and further create risks for those who would be the most vulnerable of the virus.”
4. Do kids experience the same vaccine side effects as adults?
Adolescents experienced a similar range of side effects to Pfizer’s vaccine as seen in older teens and young adults — generally seen as cold-like symptoms in the two to three days after the second dose — and had an “excellent safety profile,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in August.
None of the children in Pfizer’s clinical trials of kids ages 5-11 experienced a rare heart inflammation side effect known as myocarditis, which has been associated with the mRNA vaccines in very rare cases, mostly among young men.
5. Is there data showing COVID-19 vaccines are safe for kids?
The CDC released three studies in December showing COVID-19 vaccines are safe and effective for children.
One study, which evaluated the safety reports of more than 42,000 children ages 5 to 11 who received a Pfizer shot, found the side effects from the Pfizer vaccine were mostly mild and temporary. It also found that myocarditis, a heart inflammation side effect that has been associated with the mRNA vaccines in very rare cases, does not appear to be a risk.
A second study, which looked at data from 243 children ages 12 to 17 in Arizona, found the Pfizer vaccine was 92% effective at preventing infection. The study, conducted between July and December when delta was the dominant variant in the U.S., also found that adolescents who developed COVID-19 reported a lower percentage of time masked in school and time masked in the community.
The third study, also conducted when delta was dominant, found that among children ages 5 to 17 hospitalized due to COVID-19, less than 1% were fully vaccinated against the virus.
6. How effective are the vaccines in children?
Pfizer announced in late March that its clinical trials showed the vaccine was safe and 100% effective in children ages 12-15, similar to the 95% efficacy among adult clinical trial participants.
Marks confirmed on May 10 that after a trial with more than 2,000 children, Pfizer found no cases of infection among the children who had been given the vaccine and 16 cases of infection among the children who received a placebo.
No cases of COVID occurred in the 1,005 adolescents that received the vaccine, while there were 16 cases of COVID among the 978 kids who received the placebo, “thus indicating the vaccine was 100% effective in preventing COVID-19 In this trial,” said Marks.
7. Do kids get the same dose of the vaccines as adults?
In Pfizer’s clinical trial, children between 6 months and 5-years-old received two doses of 3-microgram shots, a tenth of the dose given to adults, three weeks apart.
Kids ages 5 to 11 are given a 10-micrograms dose of the Pfizer vaccine, one-third of the adolescent and adult dose. Like with adults and adolescents, the pediatric vaccine is delivered in two doses, three weeks apart.
For 12-to-15-year-olds, the FDA has authorized the same dosing as adults with the Pfizer two-dose vaccine.
The FDA and CDC have recommended the Pfizer booster shots now available for kids ages 12 and older be administered five months after the primary vaccine series.
8. Could COVID-19 vaccines impact puberty and menstruation?
There is currently no clinical evidence to suggest any of the COVID-19 vaccines can have long-term effects on puberty or fertility.
9. Where can kids get vaccinated against COVID-19?
Vaccines are accessible at pediatricians’ offices, children’s hospitals, pharmacies like CVS, Walgreens and Rite-Aid and school and community-based clinics.
Parents can search for appointments at Vaccines.gov to find a local provider.
ABC News’ Sasha Pezenik, Anne Flaherty, Eric Strauss, Cheyenne Haslett and Jade A. Cobern, MD, a member of the ABC News Medical Unit, contributed to this report.
(NEW YORK) — For many parents of unvaccinated toddlers in the U.S., a return to normalcy amid the COVID-19 pandemic seems out of reach.
Many have been forced to take time off work or change their schedules to provide care for their children due to school shutdowns. Rebecca Sanghvi, a public school teacher in Washington, D.C., has a 5-year-old daughter, who is vaccinated, in kindergarten and a 2-year-old son in daycare.
Working from home is not possible for her, so she juggles the house responsibilities with her husband, who’s able to shift remotely when needed. She said it’s been exhausting to cope with the pandemic while balancing her job and parenting responsibilities.
“I do think that there’s not enough attention on the difficulties that the families who can’t do that are facing with kids being quarantined, taking time off work, often unpaid,” Sanghvi said.
Mask mandates have been lifted in many parts of the country and in-person events have resumed, but many parents feel that until their kids are vaccinated, they can’t move on from the first stages of the pandemic.
Vaccines for kids under 5 are still unavailable — though Pfizer said approvals could come in the next few weeks — and currently, there are nearly 20 million kids under 5 years old in America, according to the Children’s Defense Fund.
“People don’t realize that if you have a young child, you’re still stuck in March 2020, and that we haven’t really evolved for these young children,” Deborah Schoenfeld, a mom of three in Maryland, said.
The recent surge in COVID-19 cases due to the omicron variant has taken an even bigger toll on parents of young children. Sanghavi said the reality others have been living in, where vaccinations are widely available and daily life is looking close to “normal” again, is drastically different to hers.
“We are living in this reality that I think a lot of people aren’t, and it makes these choices that we have to make with regards to risk, but also the sacrifices we have to make with regards to our work and our child care, that much more difficult, because it is really a situation that that not everybody is in anymore,” she said.
Some schools and daycares across the country have reopened despite the rise in cases, leaving young unvaccinated students with higher risks of getting contaminated, and consequently, bringing the virus home.
These surges in schools have left parents — like Anagha Phadkule — struggling to find ways to care for their children while working full-time jobs.
Phadkule is from Portland, Oregon, and works in a hospital, while her husband works from home. Their 3-year-old son, Aroosh, had to spend most of his time home after his daycare shut down twice in January due to COVID-19 outbreaks among the staff.
Her son’s unvaccinated status leaves Phadkule worried about his safety.
“It feels like a very reckless time to push your toddler into daycare and be like, ‘OK, whatever happens, happens,'” Phadkule said.
The frequent school shutdowns have led some parents to change their routines permanently. Schoenfeld, for example, made the decision to keep her son at home after his daycare was shut down several times over the past few weeks.
“My childcare situation has gotten increasingly hard. I almost feel like in 2021 it was easier. They were still figuring out what to do with COVID, but there weren’t so many cancellations and quarantines,” Schoenfeld said.
Other parents, who don’t have many options left, find themselves taking their kids to work in hopes to juggle both responsibilities. But the move has proven to be more stressful than expected.
“Sometimes, [my husband] was busy and I had to take even my kids to work for showings, for times that I had appointments with different clients … I had an issue with a client where she told me that it was unprofessional for me to show up with my kids,” Eddie Suarez, who has a 3-year-old, said.
Brigid Schulte, director of The Better Life Lab and Good Life Initiative at New America, said many parents are feeling “unheard” and “invisible,” as they don’t think their struggles are being considered.
“We’re talking about real existential threats to family survival right now — at a time when so many families thought that we had rounded the corner,” Schulte said. “This is hitting everybody. This is sort of an equal opportunity exhaustion, disruption, uncertainty and a disastrous situation for so many families.”
So what is the solution? Many parents believe the authorization of vaccines for children 5 and younger will change things for the better.
“I’d rather them take their time and … make it right, make it safe. I don’t want to feel like this push in this rush to get it done if it’s not ready yet,” Schoenfeld said. “But I don’t want to be like a hostage or prisoner waiting for the vaccine, like I need child care. That’s going to work for us right now … or something needs to, because this cannot continue. It’s too hard.”
(NEW YORK) — On the cusp of the third year of the COVID-19 pandemic, the United States is battling back the biggest surge of the virus yet with the omicron variant.
Cases, even while receding in some places, are near record levels. And daily deaths, while lower than the peak of last winter, are still averaging more than 2,000 nationwide.
Despite pitched battles over masks and vaccines, life appears somewhat normal in many respects — kids are going to school, people are going into work and large indoor gatherings and events are being held.
So, while it may be hard to imagine, many experts suggest 2022 could be the year COVID becomes an endemic disease, meaning it is always circulating within the population but at low rates or causing just seasonal outbreaks.
During a press conference Wednesday, Dr. Anthony Fauci, the nation’s top infectious disease expert, said the U.S. can get “sufficient control” over COVID-19 so it “does not disrupt us in society, does not dominate our lives, not prevent us [from doing] the things that we generally do under normal existence.”
This is because the virus will start running out of people to infect as people become immune and follow mitigation measures such as mask-wearing and testing if they have symptoms.
“We have the tools with vaccines, with boosts, with masks, with tests and with antivirals,” Fauci said.
As an endemic disease, COVID-19 would shift from becoming a global health emergency to a virus that the world learns to live with.
Public health experts say many societal changes are needed for a time when the virus circulates but is not as disruptive, such as targeted testing, more vaccination, better treatments and allowances for staying home when you’re sick.
“We really need to be shifting our thinking to how do we live with this virus rather than can we make it completely go away,” Dr. Timothy Brewer, a professor of epidemiology at UCLA Fielding School of Public Health, told ABC News. “So I think we need to sort of move into the mode of minimizing the impact of the virus as much as possible in terms of health, economic and social disruption — recognizing this virus is going to be there.”
People who are sick will be advised to stay home or wear masks in public
When the virus does become endemic, experts say people will be advised not go into school or work while sick and instead stay home, unlike before the pandemic.
If you have to leave the house, it could remain common to wear a mask on public transit or in indoor spaces.
“It will become a culture of if you’re sick you stay home,” Dr. Wafaa El-Sadr, a professor of epidemiology and medicine at Columbia University Mailman School of Public Health, told ABC News. “Don’t come to work, don’t go to school, don’t send your kids to school. There will be more of an appreciation of the collective responsibility that we have for each other.”
Currently, federal law does not require employers to provide paid sick leave to employees although some states, such as California, New York and Washington, have laws requiring it.
Antivirals may become more common in doctor’s offices and hospitals
In addition to vaccines, some antiviral treatments, from Pfizer and Merck, have come out in the past several months, specifically for those who test positive or had symptoms recently developed.
Studies have shown that these antivirals can help prevent hospitalization, especially those who are at high risk of severe illness.
Experts stress that even after the emergency phase is over, antivirals should not be considered a substitute for vaccines, but rather an extra layer of protection, specifically for at-risk groups.
“The distribution of antivirals is really important in terms of making sure immunocompromised people and people with disabilities have that sort of protection,” Abdulah Shihipar, a public health researcher at Brown University, told ABC News.
Brewer agrees and says he thinks the treatments for COVID-19 will be similar to those for HIV in that they will get better and better over time.
“HIV is no less pathogenic today than it was 40 years ago but the difference is we have very effective treatments, we have excellent antivirals against HIV,” he said. “So I think as antivirals become available that they will play a very important role” in combating COVID-19.
Shihipar says he hopes the federal government comes up with a long-term plan for distribution whether that means a program people can sign up for to get cheap subsidized drugs, setting up at pharmacies, delivering it to rural areas and so on.
Testing will be more strategic such as just screening people with symptoms
Currently, the U.S. has a model based on two types of testing: diagnostic for symptomatic people to see if they are positive for COVID, and preventive for asymptomatic people to make sure they are not infected before participating in activities or seeing others.
But in a world in which COVID-19 is more seasonal of a virus, experts say the country will have to shift to more focused testing, particularly focusing on the symptomatic.
“Now we kind of test just to test everybody, it should be more focused,” said El-Sadr. “For people who are symptomatic, if you have symptoms, it is a good idea to get tested, absolutely. So I think focusing on people who are asymptomatic will be very important.”
Right now, an average of 1.7 million tests is being administered per day in the U.S., according to the Centers for Disease Control and Prevention. Experts say that, during peaks, a minimum of 2 million is needed to keep up with demand. Supplies have been short in some cases as manufacturers ramp up production of at-home tests and omicron redefines infection levels in the country.
El-Sadr also says testing can be used for specific high-risk activities such as eating indoors with family members who are unvaccinated or having a social gathering with someone who is immunosuppressed as opposed to generally for indoor gatherings.
“We have to think of what is the strategic use of testing,” El-Sadr added.
Brewer believes testing programs currently in place at schools, such as students testing before returning and then undergoing weekly testing, won’t work in the long run.
“It’s logistically and financially too cumbersome and expensive and slow,” he said. “Given that we know up to 40% or more of people can be asymptomatic when infected and we know asymptomatic people can spread disease, we just kind of need to operate under the assumption that anyone is potentially infected and do things like hand hygiene and vaccination rather than relying on a testing strategy.”
Improved ventilation standards in workplaces and schools could be implemented
Experts say that improving indoor air quality will be one of the most important tasks, specifically as states begin to roll back mandates and mitigation measures.
Making sure indoor air is being recirculated will lower rates of cases and prevent outbreaks.
Shihipar says the Occupational Safety and Health Administration had standards for health care settings (which have since expired) that need to be expanded to all workplaces.
“We need to change the way we deal with indoor air, like how do we properly ventilate these spaces — not just for COVID but for flu and all these other diseases,” he said. “How do we make the air cleaner so that the disease spreads less?”
He continued, “We need emergency temporary workplace standards from OSHA. One for all workers would actually regulate employers to make their workplaces safe in terms of ventilation, in terms of capacity.”
Shihipar added that he’d like to see the government giving each teacher a certain number of portable air filters for their rooms and the governments and setting up clear standards of air regulation for school districts.
We may need annual COVID vaccines
Experts have suggested that annual COVID-19 vaccines, just like the flu shot, could become a reality in a world where the virus is endemic to keep antibody levels high.
They could even be adapted to combat variants just the flu shot is manufactured to combat which strains researchers think will be the most dominant.
Brewer said it will depend on two factors: how long immunity lasts after vaccination and how much the virus changes.
(NEW YORK) — Dr. Albert Lam, a geriatrician who works with nursing home patients in Palo Alto, California, was excited to be among the first to prescribe the new antiviral pill Paxlovid after one of his patients tested positive for COVID-19.
Hailed as a “game-changer” in the pandemic, Paxlovid is a drug made by Pfizer that if taken within five days of being diagnosed reduces the chance of hospitalization and death by 88% for people who are at high risk of severe illness.
The treatment has proved so promising that President Joe Biden included it in a Jan. 4 televised speech on the omicron variant, announcing that the first batch had shipped on Christmas Eve. While production would take “months,” Biden said it was in “full swing” and promised the drugs were on their way.
“The United States has more pills than any other country in the world, and our supply is going to ramp up over the coming months as more of these pills are manufactured,” Biden said.
Lam’s patient, a woman in her 80s with a history of cancer, got the drug within 24 hours and responded well.
Since then, however, the doctor hasn’t been so lucky.
Whereas nursing homes were first in line to get COVID vaccines last year, Lam now regularly scours a publicly available federal database to see if a Paxlovid prescription pops up near his location. This week, his home state of California got 9,560 doses — about 24 prescriptions for every 100,000 people.
Five weeks after federal regulators approved Paxlovid and began distributing it to states, few people can find it — omicron’s aggressive rise has quickly outstripped supplies.
According to an ABC News analysis of federal data on Paxlovid in more than 3,100 U.S. counties, three-quarters didn’t have any of the drug on hand as of Jan. 27, and about three-fifths had no access to a provider offering Paxlovid.
States are given amounts based on population, but some face more demand than others. Among the states that have the lowest rates of Paxlovid treatment on hand are Alabama, California, Florida, Idaho, New Jersey, New Mexico and Texas, according to data released by the Department of Health and Human Services.
Race also seems to be a factor in access, at least for now: Urban counties with majority nonwhite population have the lowest average of doses on hand, whereas counties with less than 10% of its population being nonwhite have the highest average of treatments on hand.
Scarcity isn’t the only problem. Doctors and pharmacists told ABC News the process of obtaining the drug is opaque, even arbitrary.
In Nevada, for example, Paxlovid primarily goes to long-term care facilities like nursing homes. But in neighboring California, state officials use a complex formula that factors in rising case numbers with other risk factors. In the District of Columbia, a few Safeway grocery stores are the primary distributors, although city health officials have asked doctors to give priority to high-risk individuals.
Dr. Christian Ramers of the Family Health Centers of San Diego, a network of clinics for low-income patients, said his clinic was able to secure its first shipment of 100 treatments of Paxlovid two weeks ago as part of a Biden program aimed at improving health equity.
But the staff also had to set up a system, using federal guidelines, to decide who gets the drugs first because there just weren’t enough. Often, that’s meant prioritizing people who initially refused a vaccination and now are at much greater risk of dying.
“The volume has been just mind-blowing for the last three to four weeks — just absolutely insane,” he said. That spike “to us means hundreds to thousands of people vying for about … 40 to 50 treatment slots per day.”
For now, he said, the reality is “if you’re vaccinated and you’re under age 65 and you don’t have a medical condition, you’re not going to get Paxlovid.”
Adding to the confusion is that many doctors are nervous about prescribing the drug for many high-risk patients because of potentially dangerous interactions with other commonly used medications, including cholesterol-lowering drugs and certain anti-depressants. Advocates say more data should be collected on people in their 80s and 90s.
But there aren’t a lot of other options.
“It is a little disappointing, and it makes me wonder: Could we do more?” said Erin Karara, a pharmacy consultant who works with nursing homes and long-term care facilities. “I mean, we’re seeing entire wings of nursing homes or facilities converted to COVID units. … It’s a lot of people affected by it.”
For its part, both the White House and Pfizer said the drug was never expected to roll out in large numbers right away, in part because of the time it takes to secure raw materials and to scale up manufacturing.
The current plan calls for 265,000 courses of treatment in January, gradually ramping up to 10 million by the end of June and 20 million by the end of September.
This week, Pfizer told ABC News it plans to increase its production of Paxlovid overall to 120 million courses of treatment globally — some 3.6 billion pills total.
Pfizer CEO Albert Bourla said producing the drug can’t be compared to its COVID vaccine.
“It is very different, the situation,” Bourla said at anindustry conference. “Any decent manufacturer of medicines can make it. But the chemistry, it is complicated, and it takes time to synthesize the active substance.”
Some conservatives still have been quick to criticize Biden’s handling of the rollout, with The Wall Street Journal’s editorial board deriding it as “Biden’s Operation Snail Speed,” writing, “Why didn’t it order more treatments sooner?”
According to one senior administration official, the White House did everything it could, including promising to Pfizer last July it would spend at least $1 billion on the drugs if it worked. This informal “handshake agreement” was intended to be a powerful incentive for the company, which doesn’t use government money to develop new products, the official said, speaking on condition of anonymity.
By then, Pfizer had already spent months preparing its supply chain and developing the drug. It agreed to allow the U.S. to receive the world’s first shipments.
A company official declined to confirm details of private discussions with the White House before the drug became available.
“Thanks to this at-risk preparation — drawing on our deep expertise — we have already shipped hundreds of thousands of Paxlovid courses in the U.S.,” a spokesperson told ABC. “We continue to work quickly to ship courses in accordance with our agreed delivery schedule.”
Two years into the pandemic, doctors still have few ways to treat COVID-19 with vaccines as the most effective option. Treatment options dwindled further this week when federal regulators pulled authorization of two types of monoclonal antibodies that had been widely used in the pandemic, including the kind given to then-President Donald Trump.
The antibody cocktails, made by Eli Lilly and Regeneron, were found to be useless against omicron, now 99.9% of all U.S. cases.
Two remaining drugs, Remdesivir and Sotrovimab, have to be administered intravenously at a medical facility. Molnupiravir, the new antiviral pill from Merck and Ridgeback Therapeutics, found to be 30% effective at preventing hospitalization and death, is authorized only for high-risk patients who can’t access other treatments.
That leaves Paxlovid — if a person can find it and take it early enough, and if the medication doesn’t put them at risk because of other drugs they are taking.
This week, the Southern Nevada Health District in Las Vegas announced it received 120 prescriptions last week and was willing to offer the medication to anyone older than 12 who is at high risk of COVID and tests positive through their clinic.
“If we can identify and treat people early in the course of their illness who otherwise may have ended up in the emergency department or hospital … we can potentially reduce the impact on our hospital system,” said Dr. Cort Lohff, chief medical officer of the public health agency.
Lam, the doctor in northern California, said he’s hopeful access will improve, particularly for nursing homes and long-term care residents.
“Frankly,” he added, “I think that if we were able to target those advanced therapeutics for the most at-risk populations, I think we would really make a bigger difference in terms of our death rate.”
(NEW YORK) — As the COVID-19 pandemic has swept the globe, more than 5.6 million people have died from the disease worldwide, including over 879,000 Americans, according to real-time data compiled by Johns Hopkins University’s Center for Systems Science and Engineering.
About 63.6% of the population in the United States is fully vaccinated against COVID-19, according to data from the Centers for Disease Control and Prevention.
Latest headlines:
-US cases down nearly 25%
-New Hampshire to sell rapid COVID-19 tests at liquor stores
-NIH trial finds mixing and matching boosters is safe and effective
Here’s how the news is developing. All times Eastern.
Jan 28, 8:22 pm
Sen. Romney tests positive for COVID-19
Utah Sen. Mitt Romney tested positive for COVID-19 Friday, his office said.
“He is currently asymptomatic and will be isolating and working remotely for the recommended period of time,” his office said.
His wife, Ann Romney, has tested negative for the virus. Both are fully vaccinated and boosted, his office said.
Jan 28, 5:06 pm
240 million free at-home tests ordered so far: White House
About 60 million American households have ordered 240 million free at-home COVID rapid tests since they became available on Jan. 18, White House officials said Friday.
The Biden administration plans to ultimately mail 1 billion free at-home rapid tests to Americans.
Additionally, the federal government has sent out “tens of millions of masks” since Biden announced last week that the government would provide 400 million N95 masks for free at pharmacies and community health centers across the country, White House principal deputy press secretary Karine Jean-Pierre said.
ABC News’ Ben Gittleson
Jan 28, 1:32 pm
US cases down nearly 25%
Federal data shows that the U.S. is now reporting an average of almost 600,000 new cases per day — a nearly 25% drop in the last two weeks, according to federal data.
Just nine states are reporting at least a 10% increase in cases: Alaska, Idaho, Kentucky, Maine, Minnesota, Montana, North Dakota, Washington and West Virginia.
All other states and territories are reporting a decrease in new cases or are at a plateau.
Nationwide, hospitalization rates are also declining, according to federal data. Just under 145,000 COVID-19-positive patients are currently in U.S. hospitals, down from 160,000 patients reported last week.
It’s not clear how many of these patients were admitted to the hospital for COVID-19 and how many coincidentally tested positive for the virus after they were admitted for other reasons.
The national daily death average now stands at nearly 2,300 — a 30% jump in the last two weeks.
ABC News’ Arielle Mitropoulos
Jan 27, 3:54 pm
San Francisco dropping masks in ‘stable cohorts’
San Francisco officials are ending indoor mask mandates for “stable cohorts” where everyone is up to date on vaccinations, like people in an office or gym setting.
The city’s health officer Dr. Susan Philip called this change, which begins Feb. 1, doable due to San Francisco’s highly vaccinated and boosted population.
“Other COVID-19 safety guidelines in these settings remain in effect and include a means for others who do not or cannot meet the vaccination requirements to join the group with the added safety of showing a negative test and wearing a mask,” San Francisco’s health department said.
(NEW YORK) — There’s growing concern among union leaders in Boston that a “disproportionate” number of educators of color may leave their jobs because of a vaccine mandate for city employees.
“We are very concerned about the possibility of losing a disproportionate number of educators of color in Boston over the vaccine policy,” Boston Teachers Union President Jessica Tang told ABC News.
Last month, Boston Mayor Michelle Wu announced that all city employees would be required to have their first shot of COVID-19 vaccine by Jan. 15 and complete the cycle by Feb. 15, unless granted a dispensation for medical or religious reasons. However, the Jan. 15 deadline was subsequently extended to Jan. 24 and again to Jan. 30.
City employees who refuse to comply will be placed on unpaid leave.
But with the vaccination policy set to go into effect next week, the Massachusetts Appeals Court on Thursday issued a temporary pause of Boston’s requirement for city workers after serious pushback from unions.
Over the past several months, teachers unions across the country, including in Chicago and New York City, have pushed back on similar mandates.
In a statement released Thursday, the BTU said it will not enforce Boston’s mandate by putting teachers on leave — at least until there’s a decision on the appeal. According to the union, over 96% of all members are vaccinated, including over 98% of teachers.
As of Friday, about 367 BTU members remained unvaccinated — disproportionately, Tang told ABC News, educators of color.
“Our union has worked extensively with the school department and community groups, especially over the last few years, to attract and retain a diverse staff that is reflective of the community that our schools serve,” Tang added.
According to city data, more than three-quarters (75.3%) of Boston’s students are Black or Latinx, compared with just over a third (33.7%) of teachers.
“Losing educators, especially in the middle of the school year, presents major difficulties across a wide array of issues,” Tang said. “We are committed to working with the district as best we can to not lose any educators.”
The union has proposed another extension on implementing the mandate, and it’s filed a formal complaint against Boston Public Schools and the city for “failing to bargain in good faith.”
A representative from Boston Public Schools pointed to the more than 80 clinics hosted by the district to help vaccinate staff and students.
“We have been working hard to ensure all of our employees understand the city’s policy and to increase access to vaccines,” a representative told ABC News.
Several other Boston unions, including those representing police and firefighters, also have pushed back on the mandate.
But Wu has repeatedly stood by that decision, insisting it’s necessary for the safety of the city, where about 95% of city employees have been vaccinated.
“Vaccination is our most powerful tool in this ongoing public health emergency, and we look forward to filing our response with the court,” Wu’s office said in a statement to ABC News.
(NEW YORK) — With the highly infectious omicron COVID-19 variant spreading rapidly across the country and overwhelming the health care system, health officials have been pleading with Americans to get vaccinated and boosted.
“The doctors and data have made crystal clear, vaccinations and boosters provide the best protection,” White House COVID-19 coordinator Jeff Zients said during a press briefing on Wednesday. “Vaccines remain our single most powerful tool.”
But despite continued public urgings from the White House and the Centers for Disease Control and Prevention, the nation’s vaccination initiation and COVID-19 booster rate continues to lag, which experts say is particularly worrisome, as efficacy continues to wane overtime.
“Booster shots are effective against both infection and serious disease,” Dr. David Dowdy, an infectious disease epidemiologist at Johns Hopkins Bloomberg School of Public Health, told ABC News. “If people don’t get boosted, we as a population are more vulnerable to the virus. To my mind, the biggest concern is that people who are vaccinated but not boosted may infect people who haven’t been vaccinated.”
As of Wednesday, just under half of those who are eligible to receive a booster — about 85 million Americans — have yet to receive their additional shot, and data shows that each day, fewer and fewer Americans are getting vaccinated. Since mid-December, the number of Americans receiving their booster every day has been cut in half — falling from more than 1 million people boosted every day to just over half a million people. In addition, 63 million eligible Americans remain totally unvaccinated.
Experts say several factors are to blame for the nation’s drop in booster shots being administered, including confusion with the CDC’s messaging and an uncertainty and lack of understanding from many about the urgency and need for boosters.
Last week, CDC Director Dr. Rochelle Walensky shared three new studies, all of which clearly demonstrated that unvaccinated individuals are at greater risk of severe illness, and even death, from COVID-19, compared to those who are vaccinated. The studies found that booster shots significantly increased protection against severe disease, both during the delta wave and at the beginning of the omicron wave.
“Protection against infection and hospitalization with the omicron variant is highest for those who are up to date with their vaccination, meaning those who are boosted when they’re eligible. There are still millions of people who are eligible for booster doses and have not yet received one,” Walensky said during a White House COVID-19 press briefing last week.
The first study found a third shot slashed the risk of visiting the ER or urgent care by 94% during delta and 82% during omicron. A second study found that the unvaccinated were nearly 14 times more likely to be infected and 53 times more likely to die, compared to the vaccinated and boosted, and a third study reported that although omicron was more likely to cause breakthrough infections compared to delta, even among the boosted, protection against more severe illness remained high.
“There may be a bit more pain and suffering with hospitalizations in those areas of the country that have not been fully vaccinated or have not gotten boosters,” Dr. Anthony Fauci told Martha Raddatz during an appearance on ABC News’ This Week on Sunday.
Messaging on vaccinations cause confusion
Health experts suggest the nation’s slowing booster campaign and the CDC’s unclear messaging and guidance are the reasons many Americans haven’t felt the need to get boosted.
“While the initial vaccination drive was met with clear communications, incentives and mandates, the booster campaign has had far less organization,” said John Brownstein, Ph.D., an epidemiologist at Boston Children’s Hospital and an ABC News contributor.
Complicating matters is the fact that the virus has already mutated several times, with new variants emerging, creating additional confusion.
“The changing science of variants and boosters has required real-time adapting of public health messaging and guidance, providing less time to prepare and convince people on the value of a third shot,” Brownstein said.
Further muddling the messaging is the discussion about whether a fourth dose of a coronavirus vaccine shot will be needed to offer protection against omicron. Israel is currently administering additional boosters to residents over the age of 60, and immunocompromised individuals, among others.
When asked whether a fourth shot will be necessary, Fauci told ABC’s This Week that it is still unclear whether an additional booster shot will be recommended, as scientists are still trying to determine how much protection is provided by the first booster.
Fauci added that it’s “quite conceivable, and I hope it’s true, that the third shot boost will give a much greater durability of protection.”
Some Americans may not understand the urgency for boosters, experts say
Although researchers report that the science behind the benefit of boosters is clear, some experts say many Americans still do not fully understand the urgency of getting boosted.
“There are many who may not yet understand the importance of [the] third dose of vaccine,” said Creech. “By giving an additional dose, particularly of an mRNA vaccine several months after those initial doses, we leverage the immune system’s ability to create long-term memory. That 1-2 punch is the best way to protect quickly and protect for a longer period of time.”
For other fully vaccinated Americans, a booster may seem unnecessary, for the time being, Dowdy said.
“For those who want protection against serious disease, but don’t care if they get a mild infection, the first series is probably sufficient. For those who want to avoid any infection at all costs, they’ve come to realize that a booster shot – while helpful – is not a ‘get out of jail free’ card,” Dowdy explained.
Despite the fact that omicron has been shown to cause less severe disease, Walensky stressed this week that as a nation, we are still facing a high overall burden of disease.
“Importantly, ‘milder’ does not mean ‘mild.’ And we cannot look past the strain on our health systems and substantial number of deaths — nearing 2,200 a day — as a result of the extremely transmissible omicron variant,” Walensky said.
Hospital officials have repeatedly stressed that the sheer number of infections caused by the new variant could still overwhelm the health care system. Nationwide, there are just under 150,000 COVID-19-positive Americans receiving care — a total which has just begun to fall after hitting a record high of 160,000 patients earlier this month.
When asked whether the C.D.C. might consider changing the definition of “fully vaccinated” to encourage more Americans to get the additional shot, Walensky reiterated that at this time, the agency is working to ensure people are “up to date” with their vaccinations.
“Right now, we’re pivoting our language, we really want to make sure people are up to date. That means if you recently got your second dose, you’re not eligible for a booster, you’re up to date. If you are eligible for a booster and you haven’t gotten it, you’re not up to date,” Walensky said.
Vaccination campaign must target both the unvaccinated and the unboosted
Experts stress the vaccination campaign must not only focus on the unboosted, but also on the 63 million eligible Americans who remain completely unvaccinated.The efforts should not be perceived as an “either/or situation, but rather a “both/and,” said Creech.
“While we want to respect the personal choices that individuals wish to make, we certainly need to invest resources to address misunderstandings or misconceptions that have led them to the decision not to vaccinate,” Creech said.
Strategies to increase overall vaccine confidence, as well as to raise awareness about the value of boosters, will also be applicable to vaccines as a whole, Creech said.
“It’s not about whether we should be prioritizing boosters over the primary vaccine series, it’s about how we message these in a way that prioritizes both,” Dowdy added.
Although the omicron surge seems to be sharply declining in many areas of the country, Americans must realize the pandemic is not over yet, Fauci stressed.
“It’s vital that we all remain vigilant in the face of this virus,” Fauci said. “It’s been a long two years. However, please now do your part to lean into this current moment. Now is the time to do what we know works: Wear a mask, get vaccinated and get boosted.”
(WASHINGTON) — Moderna announced Thursday that it’s launched early-stage clinical trials of an HIV mRNA vaccine.
The biotechnology company has teamed up with the nonprofit International AIDS Vaccine Initiative to develop the shot, which uses the same technology as Moderna’s successful COVID-19 vaccine.
The first participants in the Phase I trial were given doses at George Washington University School of Medicine and Health Sciences in Washington, D.C., according to a company statement.
“We are tremendously excited to be advancing this new direction in HIV vaccine design with Moderna’s mRNA platform,” Dr. Mark Feinberg, president and CEO of IAVI, said in a statement. “The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine.”
Nearly 38 million people worldwide — including about 1.3 million in the U.S — are living with HIV, or human immunodeficiency virus, which can lead to the potentially fatal disease AIDS.
Being diagnosed with HIV was once considered a death sentence. During the height of the U.S. AIDS epidemic in the mid-1990s, more than 50,000 deaths occurred every year, according to the Centers for Disease Control and Prevention.
Today, HIV is much more manageable with medications that can reduce viral loads to undetectable so the virus can’t be transmitted, as well as pills that can be taken to prevent infecting those who are HIV-negative.
But despite decades of research, no vaccine has ever been developed. Several candidates have entered clinical trials but failed in later stages.
The new vaccine uses mRNA, or messenger RNA, which teaches the body’s cells how to make proteins that trigger immune responses.
Researchers have developed not only a primary vaccine but also a booster to deliver HIV immunogens — molecules that elicit an immune response — via mRNA.
The hope is this process can induce specific white blood cells, called B cells, which can then turn into what are known as broadly neutralizing antibodies that can neutralize the virus.
According to the statement, Phase I of the trial will enroll 56 healthy, HIV-negative adult participants at GWU and three additional sites: Hope Clinic of Emory Vaccine Center in Atlanta; Fred Hutchinson Cancer Research Center in Seattle; and the University of Texas-Health Science Center at San Antonio.
Of the volunteers, 48 will receive one or two doses of the mRNA vaccine, and 32 also will receive the booster. The remaining eight will receive just the booster.
Researchers will then monitor for safety and efficacy of the new vaccine for up to six months after participants receive their final dose.
Moderna did not immediately respond to ABC News’ request for comment.
ABC News’ Sony Salzman contributed to this report.
