Tag Archives: Pfizer Inc/BioNTech SE

Analysis – COVID-19 pills are coming, but no substitute for vaccines, disease experts say

By Julie Steenhuysen

CHICAGO (Reuters) – Oral antiviral pills from Merck & Co and Pfizer Inc/BioNTech SE have been shown to significantly blunt the worst outcomes of COVID-19 if taken early enough, but doctors warn vaccine hesitant people not to confuse the benefit of the treatments with prevention afforded by vaccines.

While 72% of American adults have gotten a first shot of the vaccine, according to a Kaiser Family Foundation poll, the pace of vaccination has slowed, as political partisanship in the United States divides views on the value and safety of vaccines against the coronavirus.

Vaccine mandates by employers, states and the administration of U.S. President Joe Biden have helped increase vaccinations but also fueled that controversy.

Some disease experts fear the arrival of oral COVID-19 treatments may further impede vaccination campaigns. Preliminary results of a survey of 3,000 U.S. citizens by the City University of New York (CUNY) School of Public Health suggest the drugs could “hamper the effort to get people vaccinated,” said Scott Ratzan, an expert in health communication at CUNY, who led the research.

Ratzan said one out of every eight of those surveyed said they would rather get treated with a pill than be vaccinated. “That is a high number,” Ratzan said.

The concern follows news on Friday from Pfizer, maker of a leading COVID-19 vaccine, that its experimental antiviral pill Paxlovid cut the risk of hospitalization and death from the disease by 89% in high-risk adults.

Pfizer’s results followed news from Merck and partner Ridgeback Biotherapeutics on Oct. 1 that their oral antiviral drug cut hospitalization and death by half. That drug, known as molnupiravir, won conditional approval in the UK on Thursday. Both need clearance from U.S. health regulators but could be on the market in December.

“By relying exclusively on an antiviral drug, it’s a bit of a roll of the dice in terms of how you will do. Clearly, it’s going to be better than nothing, but it’s a high-stakes game to play,” said Dr. Peter Hotez, a vaccine expert and professor of molecular virology and microbiology at Baylor College of Medicine.

Six infectious disease experts interviewed by Reuters were equally enthusiastic about the prospect of effective new treatments for COVID-19 and agreed they were no substitute for vaccines.

Even in the face of the highly transmissible Delta variant of the virus, the vaccines from Pfizer/BioNTech remain effective, cutting the risk of hospitalization by a combined 86.8%, according to a government study of U.S. veterans.

They said some unvaccinated people have already relied on monoclonal antibodies – drugs that need to be delivered through intravenous IV infusions or injections – as a backstop in case they become infected. “I think the Pfizer news is terrific news. It goes hand in hand with vaccination. It doesn’t replace it,” said Dr. Leana Wen, an emergency physician and public health professor at George Washington University and Baltimore’s former health commissioner.

Choosing not to get vaccinated “would be a tragic mistake,” said Albert Bourla, chief executive officer of Pfizer Inc. “These are treatments. This is for the unfortunate who will get sick,” Bourla told Reuters in an interview on Friday. “This should not be a reason not to protect yourself and to put yourself, your household and society in danger.”

ANTIVIRAL CHALLENGES

One main reason not to rely on the new pills, the experts said, is that antiviral medications, which stop the virus from replicating in the body, must be given in a narrow window early in the disease because COVID-19 has different phases.

In the first phase, the virus rapidly replicates in the body. A lot of the worst effects of COVID-19, however, occur in the second phase, arising from a defective immune response that gets triggered by the replicating virus, said Dr. Celine Gounder, an infectious disease expert and the CEO and founder of Just Human Productions, a non-profit multimedia organization.

“Once you develop shortness of breath or other symptoms that would lead you to be hospitalized, you are in that dysfunctional immune phase where the antivirals are really not going to provide much benefit,” she said. Hotez agreed. He said getting treated early enough could be challenging because the window when the virus transitions from the replication phase to the inflammatory phase is fluid. “For some people, that will happen earlier; for some, later,” Hotez said. Hotez said many people in the early phase of the illness feel surprisingly well and may be unaware that their oxygen levels are dropping, one of the first signs that the inflammatory phase of the disease has started. “Oftentimes, you’re not going to realize that you’re getting sick until it’s too late,” he said.

(Reporting by Julie Steenhuysen; Additional reporting by Josephine Mason in London, Deena Beasley in Los Angeles and Manojna Maddipatla in Bengaluru; editing by Caroline Humer and Grant McCool)

U.S. begins effort to vaccinate young children against COVID-19

By Carl O’Donnell and Maria Caspani

(Reuters) -The United States on Wednesday began administering the COVID-19 vaccine to children ages 5 to 11, the latest group to become eligible for the shots that provide protection against the illness to recipients and those around them.

On Tuesday, the U.S. Centers for Disease Control and Prevention recommended the Pfizer Inc/BioNTech SE shot for broad use in that age group.

Only a limited number of the 15 million shots being distributed now will be available on Wednesday. They are expected to be more widely accessible at pediatrician’s offices, children’s hospitals and pharmacies next week.

The big national pharmacy chains, Walgreens Boots Alliance, CVS Health and Rite Aid are among those offering appointments for this weekend.

Virginia Commonwealth University Health received the vaccine on Tuesday but will probably not start administering it until next week because of logistics and safety protocols, Director of Pharmacy Services Rodney Stilner told Reuters.

“For us to be able to receive the vaccine and even start today would just be like, almost impossible,” he said.

While about 58% of Americans are fully vaccinated against COVID-19, some 28 million children under 12 have not been eligible until now.

The 10-microgram shot of the Pfizer/BioNTech vaccine authorized for school-age kids – a third the strength given to adolescents and adults – offers protection from the Delta variant of the virus that has led to thousands of pediatric hospitalizations.

‘MUCH EASIER, MUCH SAFER’

The vaccine, shown to be more than 90% effective at preventing symptomatic infection in children, also provides an avenue for fewer quarantines or school closures and more normal activities and freedoms.

“I think it’s going to make the issue of schools much easier, much safer,” White House chief medical adviser Dr. Anthony Fauci said in an interview with CNN on Wednesday.

Still, it remains unclear how many parents will jump at the chance. Even many who have been vaccinated themselves are more divided over whether to vaccinate their own younger children, given that severe COVID-19 is much less common for them.

There were no new safety issues in Pfizer’s study of the vaccine in thousands of children, but there is also no long-term data for its use.

The U.S. Food and Drug Administration authorized the Pfizer/ BioNTech vaccine for children aged 5 to 11 years on Friday. A few other countries, including China, are already vaccinating children. The European Union and Canadian regulators are currently considering Pfizer’s application for the vaccine in this younger age group.

So far, only Pfizer’s shot has been authorized for use in the United States for those under age 16.

Moderna Inc has delayed its request for authorization for its vaccine for children aged 6 to 11 and is waiting on an FDA review of safety data in connection with its application for 12- to 17-year old’s.

The states with the highest adult COVID-19 vaccination rates are preparing bigger pushes to get children inoculated than states where hesitancy remains strong, potentially widening the gaps in protection nationwide, public health officials and experts said.

COVID-19 vaccines have emerged as yet another issue exposing deep political fault lines in the United States that led to opposing stances on vaccinations, face covering and other pandemic restrictions in various parts of the country.

California, New York and Washington state, all led by Democratic governors who have promoted vaccination and mask-wearing, are setting up mobile sites and high-volume vaccination clinics for children, spokespeople for the public health departments of those states said.

California has also mandated that school-age children get a COVID-19 vaccine once their age group is eligible, a measure being considered in New York and Washington.

Republican state governors have largely resisted measures such as mask mandates or vaccine requirements in workplaces, schools and public venues. More than a dozen states, including Florida and Texas, have tried to block schools from imposing such requirements themselves.

(Reporting by Carl O’Donnell; additional reporting and writing by Maria Caspani; Editing by Caroline Humer, Jonathan Oatis and Bill Berkrot)

J&J vaccine drive stalls out in U.S after safety pause

By Michael Erman

NEW YORK (Reuters) – Safety concerns about Johnson & Johnson’s COVID-19 vaccine along with overall flagging demand for vaccinations have slowed its U.S. rollout to a crawl, leaving close to half of the 21 million doses produced for the United States sitting unused.

J&J’s vaccine was supposed to be an important tool for reaching rural areas and vaccine hesitant Americans because it requires only one shot and has less stringent storage requirements than the two-dose vaccines from Pfizer Inc/BioNTech SE and Moderna Inc.

But Americans have largely eschewed it over the six weeks it has been back in use after a pause to study a rare safety issue, according to data from the U.S. Center for Disease Control and Prevention (CDC) and interviews with health officials and pharmacists in eight states across the country.

“We went from having a waiting list to give somebody a shot to having maybe one shot a day or four shots a day,” Michelle Vargas, owner of independent Lamar Family Pharmacy in Lamar, South Carolina, said of plunging demand for the J&J shot in the small rural community. “They’re concerned for their safety. I think that’s the biggest hurdle right now.”

In the week ended May 25, fewer than 650,000 Americans received the J&J shot, accounting for about 5% of total vaccinations administered and down from nearly 3 million in the week leading up to the pause, CDC data shows.

Demand for all the vaccines has slowed since mid-April, but the drop has been significantly steeper for the J&J shot.

The slowdown may mean some J&J doses will expire unused at a time when global demand for any COVID-19 vaccine is high. J&J doses will be among the 25 million donated by the United States announced by the White House last Thursday.

At least 13 lots of the vaccine have expiration dates of June 27 or earlier, according to a J&J website. It is not clear how many doses that reflects, but the vaccine has a 3-month shelf life and most doses were sent out by early April, including 11 million in the first week. J&J has another 100 million doses on hand but shipment timing is uncertain.

A J&J spokesperson declined to comment on the number of doses expiring before the end of June.

J&J is working with the U.S. government and health authorities to support use of its vaccine, the spokesperson said in a statement, calling it an important tool in the global fight against COVID-19.

“We remain committed to helping end this deadly pandemic as quickly as possible,” J&J said.

‘LET’S JUST STICK WITH PFIZER AND MODERNA’

The CDC and Food and Drug Administration paused use of the J&J vaccine for nearly two weeks in mid-April to investigate links to cases of a very rare, potentially life-threatening condition called thrombosis with thrombocytopenia syndrome (TTS), which involves blood clots and low platelet counts.

Regulators decided that the vaccine’s benefits outweigh the risk. The condition has also been linked to AstraZeneca’s COVID-19 vaccine.

David Kohll, pharmacist at Kohll’s Pharmacy with six locations in Nebraska, said before the safety issue, several companies arranged for him to provide J&J vaccines to employees.

“Some of them are trucking companies and some others with more blue-collar or hard-to-get-to employees. They wanted us to go with all J&J,” Kohll said. After the safety pause, “probably 80 percent of them said ‘Let’s just stick with Pfizer and Moderna.'”

Public health officials said during the pause they found the Pfizer and Moderna vaccines were adequate substitutes in the mobile and walk-up clinics where they had been using J&J.

“Once we get them in for the first dose, we’ve got them and they will come back for the second dose,” said Dr. Karen Landers, a public health official in Alabama.

Use of J&J’s shot has fallen in states like Wyoming and Alabama with low vaccine uptake and in places like Maine and Oregon, where vaccination rates are high, according to state and CDC data.

Not everyone has seen a sharp drop-off in demand for the J&J vaccine. Richard Stryker, who runs the Bayshore Pharmacy in Atlantic Highlands, N.J., said he has seen plenty of interest, particularly from seniors who are at lower risk for the clotting issue and prefer the single injection.

J&J has said it is not currently selling the vaccine for a profit. The lower demand this year is immaterial to its financials, SVB Leerink analyst Danielle Antalffy said at the time of the safety pause.

But competitors Pfizer, BioNTech and Moderna could benefit as developed countries sign future deals for booster shots. Pfizer and BioNTech’s EU deal alone could be worth at least $16 billion – as much as double that if all options are exercised – for the companies through 2023, based on current prices.

Rollout of the J&J shot has had other stumbles as well. Regulators shut down production at the largest U.S. plant making the vaccine due to cross-contamination at the site with the AstraZeneca shot. No new doses have been distributed in the United States since mid-May.

U.S. regulators are deciding whether it is safe to release up to 100 million doses of J&J’s vaccine produced at that plant. The dwindling U.S. demand could provide additional flexibility to donate millions of doses.

(Reporting by Michael Erman; Editing by Caroline Humer and Bill Berkrot)