Pfizer
Pfizer begins testing omicron-matched COVID shots in adults
Pfizer is enrolling healthy adults to test a reformulated COVID-19 vaccine that matches the hugely contagious omicron variant, to see how it compares with the original shots.
Pfizer and its partner BioNTech announced the study on Tuesday.
COVID-19 vaccine-makers have been updating their shots to better match omicron in case global health authorities decide the change is needed.
Omicron is more likely than previous variants to cause infection even in people who’ve been vaccinated, but it’s not yet clear that a change to the vaccine recipe will be ordered. Among the issues regulators are weighing: Some of the first places to face an omicron surge already are seeing the mutant wane — and there’s no way to know if the next variant that arises will resemble omicron or be totally different.
The original vaccines still offer good protection against severe illness and death. Studies in the U.S. and elsewhere have made clear that adding a booster dose strengthens that protection and improves the chances of avoiding even a milder infection.
Another wrinkle in deciding whether vaccines need an update: A new U.S. report Tuesday echoes data from Britain and South Africa that omicron infections cause less severe illness — at least in part because so many people have some protection from vaccination or prior infection. During the omicron surge, 13% of hospitalized COVID-19 patients ended up in intensive care, compared with about 18% during two earlier waves, according to the Centers for Disease Control and Prevention.
Still, “we recognize the need to be prepared in the event this protection wanes over time and to potentially help address omicron and new variants in the future,” Kathrin Jansen, Pfizer’s vaccine research chief, said in a statement.
The new U.S. study will include up to 1,420 volunteers ages 18 to 55 to test the updated omicron-based shots for use as a booster or for primary vaccinations. Researchers will examine the tweaked vaccine’s safety and how it revs up the immune system in comparison to the original shots.
Full study results will take many months as volunteers receive multiple vaccine doses — and as researchers measure how long virus-fighting antibodies remain at high levels after an omicron-adapted dose versus the regular booster.
Pfizer’s CEO told CNBC earlier this month that the company could have some omicron-matched doses ready as early as March. But doing what the company calls “at-risk” manufacturing doesn’t mean those doses will be rolled out to the public. Pfizer and other vaccine makers also have brewed and tested experimental doses to match previous variants, changes that ultimately weren’t needed but offered valuable practice at tweaking the recipe.
For the new study, one group of about 600 volunteers who received two doses of the current Pfizer vaccine three to six months ago will receive either one or two omicron-based shots as boosters. Another 600 who have already gotten three regular doses of the Pfizer vaccine will be given a fourth dose of either the regular vaccine or the omicron-matched version.
The study also will enroll some unvaccinated volunteers who will receive three doses of the omicron-based vaccine.
Pfizer plans to produce 4 billion vaccine doses in 2022, and said Tuesday the amount isn’t expected to change if an omicron-adapted version is needed.
FDA expands Pfizer boosters for more teens as omicron surges
The U.S. is expanding COVID-19 boosters as it confronts the omicron surge, with the Food and Drug Administration allowing extra Pfizer shots for children as young as 12.
Boosters already are recommended for everyone 16 and older, and federal regulators on Monday decided they’re also warranted for 12- to 15-year-olds once enough time has passed since their last dose.
But the move, coming as classes restart after the holidays, isn’t the final step. A panel to the Centers for Disease Control and Prevention is expected to decide later this week whether to recommend boosters for the younger teens with a final decision by Dr. Rochelle Walensky, the CDC’s director.
The FDA also said everyone 12 and older who's eligible for a Pfizer booster can get one as early as five months after their last dose rather than six months.
FDA vaccine chief Dr. Peter Marks said even though serious illness is uncommon in younger teens, a booster will help them avoid that risk — while also helping reduce the spread of omicron or any other coronavirus mutant.
“Hopefully this will be not just a call for people to go get their booster shot,” but for the tens of millions of unvaccinated Americans to rethink that choice, Marks said. “It's not too late to start to get vaccinated.”
Also read: FDA paves way for Pfizer COVID-19 vaccinations in young kids
The FDA based its latest booster decision largely on real-world data from Israel that found no new safety concerns when 6,300 12- to 15-year-olds got a Pfizer booster five months after their second dose.
Likewise, the FDA said even more data from Israel showed no problems with giving anyone eligible for a Pfizer booster that extra dose a month sooner than the six months that until now has been U.S. policy.
The chief safety question for younger teens is a rare side effect called myocarditis, a type of heart inflammation seen mostly in younger men and teen boys who get either the Pfizer or Moderna vaccines. The vast majority of cases are mild — far milder than the heart inflammation caused by COVID-19 — and they seem to peak in older teens, the 16- and 17-year-olds.
Marks said the side effect occurs in about 1 in 10,000 men and boys ages 16 to 30 after their second shot — but that a third dose appears less risky, by about a third. That's probably because more time has passed before the booster than between the first two shots, he said.
While the FDA didn’t consult its independent scientific advisers before making that decision, the CDC's own advisory panel is sure to closely weigh how much benefit this age group is likely to get before backing the extra shot.
Vaccines still offer strong protection against serious illness from any type of COVID-19. But health authorities are urging everyone who’s eligible to get a booster dose for their best chance at avoiding milder breakthrough infections from the highly contagious omicron mutant.
Children tend to suffer less serious illness from COVID-19 than adults. But child hospitalizations are rising during the omicron wave -- most of them unvaccinated.
Pediatrician and global health expert Dr. Philip Landrigan of Boston College welcomed the FDA's decisions, but stressed that the main need is to get the unvaccinated their first shots.
“It is among unvaccinated people that most of the severe illness and death from COVID will occur in coming weeks,” he said in an email. "Many thousands of lives could be saved if people could persuade themselves to get vaccinated.”
Also read: Pfizer asks FDA to OK COVID-19 booster shots for all adults
The vaccine made by Pfizer and its partner BioNTech is the only U.S. option for children of any age. About 13.5 million 12- to 17-year-olds — just over half that age group — have received two Pfizer shots, according to the CDC.
For families hoping to keep their children as protected as possible, the booster age limit raised questions.
The older teens, 16- and 17-year-olds, became eligible for boosters in early December. But original vaccinations opened for the younger teens, those 12 to 15, back in May. That means those first in line in the spring, potentially millions, are about as many months past their last dose as the slightly older teens.
As for even younger children, kid-size doses for 5- to 11-year-olds rolled out more recently, in November -- and experts say healthy youngsters should be protected after their second dose for a while. But the FDA also said Monday that if children that young have severely weakened immune systems, they will be allowed a third dose 28 days after their second. That’s the same third-dose timing already recommended for immune-compromised teens and adults.
Pfizer is studying its vaccine, in even smaller doses, for children younger than 5.
What about timing of boosters for adults who got the Moderna or Johnson & Johnson vaccines?
The FDA said it didn’t have any new data from Moderna to back a timing change and people who’d already had two Moderna shots should continue to wait six months for a booster. As for people who originally got the single-dose J&J shot, the U.S. already recommends another dose of any vaccine two months later.
Pfizer tests extra COVID shot for kids under 5 in setback
Pfizer said Friday it was changing plans and testing three doses of its COVID-19 vaccine in babies and preschoolers after the usual two shots didn’t appear strong enough for some of the children.
Pfizer announced the change after a preliminary analysis found 2- to 4-year-olds didn’t have as strong an immune response as expected to the very low-dose shots the company is testing in the youngest children.
It’s disappointing news for families anxious to vaccinate their tots. Pfizer had expected data on how well the vaccines were working in children under 5 by year’s end, and it’s not clear how long the change will delay a final answer.
Pfizer and its partner BioNTech said if the three-dose study is successful, they plan to apply for emergency authorization sometime in the first half of 2022.
Read: Pfizer says COVID booster offers protection against omicron
A kid-sized version of Pfizer’s vaccine already is available for 5- to 11-year-olds, one that’s a third of the dose given to everyone else 12 and older.
For children younger than 5, Pfizer is testing an even smaller dose, just 3 micrograms or a tenth of the adult dose.
Researchers analyzed a subset of youngsters in the study a month after their second dose to see if the tots developed levels of virus-fighting antibodies that were similar to teens and young adults who get the regular shots.
The very low-dose shots appeared to work in youngsters under age 2, who produced similar antibody levels. But the immune response in 2- to 4-year-olds was lower than the study required, Pfizer vaccine research chief Kathrin Jansen said Friday in a call with investors.
Read: Pfizer agrees to let other companies make its COVID-19 pill
Rather than trying a higher-dose shot for the preschoolers, Pfizer decided to expand the study to evaluate three of the very low-dose shots in all the study participants — from 6 months up to age 5. That third shot will come at least two months after the youngsters’ second dose.
No safety concerns have been spotted in the study, the companies said.
Jansen cited other data showing a booster shot for people 16 and older restores strong protection, a jump in immunity that scientists hope also will help fend off the new omicron variant.
The companies also are preparing to test a booster for 5- to 11-year-olds, who are just now getting their two-dose vaccinations. And they are testing different dose options for teen boosters.
Jansen said if the additional pediatric testing is successful, “we would have a consistent three-dose vaccine approach for all ages.”
CDC recommends Pfizer, Moderna COVID-19 shots over J&J's
Most Americans should be given the Pfizer or Moderna vaccines instead of the Johnson & Johnson shot that can cause rare but serious blood clots, U.S. health officials said Thursday.
The strange clotting problem has caused nine confirmed deaths after J&J vaccinations — while the Pfizer and Moderna vaccines don't come with that risk and also appear more effective, said advisers to the Centers for Disease Control and Prevention.
The panel recommended the unusual move of giving preference to the Pfizer and Moderna vaccines, and late Thursday the CDC's director, Dr. Rochelle Walensky, accepted the panel's advice.
Until now the U.S. has treated all three COVID-19 vaccines available to Americans as an equal choice, since large studies found they all offered strong protection and early supplies were limited. J&J's vaccine initially was welcomed as a single-dose option that could be especially important for hard-to-reach groups like homeless people who might not get the needed second dose of the Pfizer or Moderna options.
Also read: Pfizer confirms COVID pill’s results, potency versus omicron
But the CDC's advisers said during a meeting Thursday that it was time to recognize a lot has changed since vaccines began rolling out a year ago. More than 200 million Americans are considered fully vaccinated, including about 16 million who got the J&J shot.
New data from unprecedented safety tracking of all those vaccinations persuaded the panel that while the blood clots linked to J&J's vaccine remain very rare, they're still occurring and not just in younger women as originally thought.
In a unanimous vote, the advisers decided the safer Pfizer and Moderna vaccines are preferred. But they said the shot made by J&J's Janssen division still should be available if someone really wants it — or has a severe allergy to the other options.
“I would not recommend the Janssen vaccine to my family members” but some patients may -- and should be able to -- choose that shot, said CDC adviser Dr. Beth Bell of the University of Washington.
The clotting problems first came up last spring, with the J&J shot in the U.S. and with a similar vaccine made by AstraZeneca that is used in other countries. Eventually U.S. regulators decided the benefits of J&J's one-and-done vaccine outweighed what was considered a very rare risk — as long as recipients were warned.
European regulators likewise continued to recommend AstraZeneca's two-dose vaccine although, because early reports were mostly in younger women, some countries issued age restrictions.
COVID-19 causes deadly blood clots, too. But the vaccine-linked kind is different, believed to form because of a rogue immune reaction to the J&J and AstraZeneca vaccines because of how they're made. It forms in unusual places, such as veins that drain blood from the brain, and in patients who also develop abnormally low levels of the platelets that form clots. Symptoms of the unusual clots, dubbed “thrombosis with thrombocytopenia syndrome,” include severe headaches a week or two after the J&J vaccination — not right away — as well as abdominal pain and nausea.
Also read: US expands Pfizer COVID boosters, opens extra dose to age 16
While it’s still very rare, the Food and Drug Administration told health care providers this week that more cases have occurred after J&J vaccinations since the spring. They occur most in women ages 30 to 49 -- about once for every 100,000 doses administered, the FDA said.
Overall, the government has confirmed 54 clot cases— 37 in women and 17 in men, and nine deaths that included two men, the CDC's Dr. Isaac See said Thursday. He said two additional deaths are suspected.
The CDC decides how vaccines should be used in the U.S., and its advisers called the continuing deaths troubling. In comparing the pros and cons of all the vaccines, the panelists agreed that side effects from the Pfizer and Moderna vaccines weren't as serious — and that supplies now are plentiful.
Nor is J&J still considered a one-and-done vaccine, several advisers noted. The single-dose option didn't prove quite as protective as two doses of the Pfizer and Moderna vaccines. Plus, with extra-contagious virus mutants now spreading, booster doses now are recommended.
For J&J recipients, a booster is recommended at least two months after vaccination. U.S. health officials had previously OK’d mixing vaccines for booster shots.
Several countries, including Canada, already have policies that give preference to the Pfizer and Moderna vaccines. But J&J told the committee its vaccine still offers strong protection and is a critical option especially in parts of the world without plentiful vaccine supplies or for people who don't want a two-dose shot.
While blood clots are rare, “unfortunately cases of COVID-19 are not,” J&J’s Dr. Penny Heaton said.
The U.S. is fortunate in its vaccine availability and Thursday's action shouldn't discourage use of J&J's vaccine in places around the world where it's needed, said CDC adviser Dr. Matthew Daley of Kaiser Permanente Colorado.
The FDA also warned this week that another dose of the J&J vaccine shouldn't be given to anyone who developed a clot following either a J&J or AstraZeneca shot.
The committee also heard some of the first data on reported side effects of Pfizer vaccinations in younger children. Early last month, the CDC recommended a two-dose series for that age group, and more than 7 million doses have been given so far. But few problems have been reported. Of the 80 reported cases of serious side effects, about 10 involved a form of inflammation that has been seen in male teens and young adults.
Pfizer confirms COVID pill’s results, potency versus omicron
Pfizer said Tuesday that its experimental pill to treat COVID-19 appears effective against the omicron variant.
The company also said full results of its 2,250-person study confirmed the pill’s promising early results against the virus: The drug reduced combined hospitalizations and deaths by about 89% among high-risk adults when taken shortly after initial COVID-19 symptoms.
Separate laboratory testing shows the drug retains its potency against the omicron variant, the company announced, as many experts had predicted. Pfizer tested the antiviral drug against a man-made version of a key protein that omicron uses to reproduce itself.
The updates come as COVID-19 cases, deaths and hospitalization are all rising again and the U.S. topped 800,000 pandemic deaths. The latest surge, driven by the delta variant, is accelerating due to colder weather and more indoor gatherings, even as health officials brace for the impact of the emerging omicron mutant.
The Food and Drug Administration is expected to soon rule on whether to authorize Pfizer’s pill and a competing pill from Merck, which was submitted to regulators several weeks earlier. If granted, the pills would be the first COVID-19 treatments that Americans could pick up at a pharmacy and take at home.
Read: Pfizer says COVID booster offers protection against omicron
President Joe Biden called Pfizer’s drug “another potentially powerful tool in our fight against the virus,” in a statement Tuesday.
The U.S. government has agreed to purchase enough of Pfizer’s drug to treat 10 million people. But company executives have indicated that initial supplies will be limited, with only enough to treat tens of thousands of people before the end of the year. By March Pfizer hopes to ramp up production to provide millions of courses of treatment.
Pfizer’s data could help reassure regulators of its drug’s effectiveness after Merck disclosed smallerthan-expected benefits for its drug in final testing. Late last month, Merck said that its pill reduced hospitalizations and deaths by 30% in high-risk adults.
Both companies initially studied their drugs in unvaccinated adults who face the gravest risks from COVID-19, due to older age or health problems, such as asthma or obesity.
Pfizer is also studying its pill in lower-risk adults — including a subset who are vaccinated — but reported mixed data for that group on Tuesday.
In interim results, Pfizer said its drug failed to meet its main study goal: sustained relief from COVID-19 for four days during or after treatment, as reported by patients. But the drug did achieve a second goal by reducing hospitalizations by about 70% among that group, which included otherwise healthy unvaccinated adults and vaccinated adults with one or more health issues. Less than 1% of patients who got the drug were hospitalized, compared with 2.4% of patients who got a dummy pill.
Read: Pfizer agrees to let other companies make its COVID-19 pill
An independent board of medical experts reviewed the data and recommended Pfizer continue the study to get the full results before proceeding further with regulators.
Across both of Pfizer’s studies, adults taking the company’s drug had a 10-fold decrease in virus levels compared with those on placebo.
The prospect of new pills to fight COVID-19 can’t come soon enough for communities in the Northeast and Midwest, where many hospitals are once again being overloaded by incoming virus cases.
Both the Merck and Pfizer pills are expected to perform well against omicron because they don’t target the coronavirus’ spike protein, which contains most of the new variant’s mutations.
Centers for Disease Control and Prevention Director Rochelle Walensky, appearing on NBC’s “Today” on Tuesday, said the best way for people to protect themselves against COVID-19 is to get vaccinated and get a booster shot. She said the Pfizer pill, if authorized by the FDA, “will be another great tool, but we need to diagnose people early.”
US expands Pfizer COVID boosters, opens extra dose to age 16
U.S. health authorities again expanded the nation's booster campaign Thursday, opening extra doses of Pfizer’s COVID-19 vaccine to several million 16- and 17-year-olds.
The U.S. and many other nations already were urging adults to get booster shots to pump up immunity that can wane months after vaccination, calls that intensified with the discovery of the worrisome new omicron variant.
On Thursday, the Food and Drug Administration gave emergency authorization for 16- and 17-year-olds to get a third dose of the vaccine made by Pfizer and its partner BioNTech — once they're six months past their last dose. And hours later, the Centers for Disease Control and Prevention lifted the last barrier as Dr. Rochelle Walensky, the agency's director, issued a statement strongly encouraging those teens to get their booster as soon as it's time.
Boosters are important considering that protection against infection wanes over time and “we’re facing a variant that has the potential to require more immunity to be protected," Walensky told The Associated Press.
Also read: Pfizer says COVID booster offers protection against omicron
About 200 million Americans are fully vaccinated, including about 4.7 million 16- and 17-year-olds, many of whom got their first shots in the spring and would be eligible for a booster.
“Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19,” Dr. Janet Woodcock, acting FDA commissioner, said in a statement.
The Pfizer vaccine is the only option in the U.S. for anyone younger than 18, either for initial vaccination or for use as a booster. It’s not yet clear if or when teens younger than 16 might need a third Pfizer dose. But Walensky said the CDC and FDA would closely watch data on 12- to 15-year-olds because if they eventually need boosters, “we again will want to act swiftly.”
Vaccinations for children as young as 5 just began last month, using special low-dose Pfizer shots. By this week, about 5 million 5- to 11-year-olds had gotten a first dose.
The extra-contagious delta variant is causing nearly all COVID-19 infections in the U.S., and in much of the world. It’s not yet clear how vaccines will hold up against the new and markedly different omicron mutant. But there’s strong evidence that boosters offer a jump in protection against delta-caused infections, currently the biggest threat.
“The booster vaccination increases the level of immunity and dramatically improves protection against COVID-19 in all age groups studied so far,” BioNTech CEO Ugur Sahin said in a statement.
Complicating the decision to extend boosters to 16- and 17-year-olds is that the Pfizer shot — and a similar vaccine made by Moderna — have been linked to a rare side effect. Called myocarditis, it’s a type of heart inflammation seen mostly in younger men and teen boys.
Also read: Vaccine makers racing to update COVID shots, just in case
The FDA said rising COVID-19 cases in the U.S. mean the benefits of boosters greatly outweighed the potential risk from the rare side effect, especially as the coronavirus itself can cause more serious heart inflammation.
Health officials in Israel, which already gives boosters to teens, have said the side effect continues to be rare with third doses.
A U.S. study this week offered additional reassurance. Researchers from children’s hospitals around the country checked medical records and found the rare side effect usually is mild and people recover quickly. The research was published Monday in the journal Circulation.
Pfizer says COVID booster offers protection against omicron
Pfizer said Wednesday that a booster dose of its COVID-19 vaccine may protect against the new omicron variant even though the initial two doses appear significantly less effective.
Pfizer and its partner BioNTech said lab tests showed a booster dose increased by 25-fold the level of so-called neutralizing antibodies against omicron.
Pfizer announced the preliminary laboratory data in a press release and it hasn’t yet undergone scientific review. The companies already are working to create an omicron-specific vaccine in case it’s needed.
READ: Omicron v. delta: Battle of coronavirus mutants is critical
Scientists have speculated that the high jump in antibodies that comes with a third dose of COVID-19 vaccines might be enough to counter any decrease in effectiveness.
Antibody levels predict how well a vaccine may prevent infection with the coronavirus but they are just one layer of the immune system’s defenses. Pfizer said two doses of the vaccine may still induce protection against severe disease.
“Although two doses of the vaccine may still offer protection against severe disease caused by the Omicron strain, it’s clear from these preliminary data that protection is maximized with a third dose of our vaccine,” Pfizer CEO Albert Bourla said in a statement.
READ: How can I protect myself from the new omicron variant?
Pfizer’s announcement had an immediate impact on U.S. markets. Futures that had pointed to a lower open reversed course in seconds and swung solidly to the positive with the Dow jumping almost 200 points.
Pfizer asks US officials to OK promising COVID-19 pill
Pfizer asked U.S. regulators Tuesday to authorize its experimental pill for COVID-19, setting the stage for a likely launch this winter of a promising treatment that can be taken at home.
The company’s filing comes as new infections are rising once again in the United States, driven mainly by hot spots in states where colder weather is driving more Americans indoors.
Pfizer’s pill has been shown to significantly cut the rate of hospitalizations and deaths among people with coronavirus infections. The Food and Drug Administration is already reviewing a competing pill from Merck and several smaller drugmakers are also expected to seek authorization for their own antiviral pills in the coming months.
Read: Pfizer agrees to let other companies make its COVID-19 pill
“We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application,” said Pfizer CEO Albert Bourla, in a statement.
Specifically, Pfizer wants the drug available for adults who have mild-to-moderate COVID-19 infections and are at risk of becoming seriously ill. That’s similar to how other drugs are currently used to treat the disease. But all FDA-authorized COVID-19 treatments require an IV or injection given by a health professional at a hospital or clinic.
The FDA is holding a public meeting on the Merck pill later this month to get the opinion of outside experts before making its decision. The agency isn’t required to convene such meetings and it’s not yet known whether Pfizer’s drug will undergo a similar public review.
Some experts predict COVID-19 treatments eventually will be combined to better protect against the worst effects of the virus.
Pfizer reported earlier this month that its pill cut hospitalizations and deaths by 89% among high-risk adults who had early symptoms of COVID-19. The company studied its pill in people who were unvaccinated and faced the worst risks from the virus due to age or health problems, such as obesity. If authorized, the FDA will have to weigh making the pill available for vaccinated people dealing with breakthrough infections, since they weren’t part of the initial tests.
Read: US announces another 14mn Pfizer jabs for Bangladesh
For best results, patients need to start taking the pills within three days of symptoms, underscoring the need for speedy testing and diagnosis. That could be a challenge if another COVID-19 surge leads to testing delays and shortages seen last winter.
Pfizer’s drug is part of a decades-old family of antiviral drugs known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme which viruses need to multiply in the human body. That’s different than the Merck pill, which causes tiny mutations in the coronavirus until the point that it can’t reproduce itself.
On Tuesday, Pfizer signed a deal a with U.N.-backed group to allow generic drugmakers to produce low-cost versions of the pill for certain countries. Merck has a similar deal for its pill, which was authorized in Britain earlier this month.
Read: Pfizer asks FDA to OK COVID-19 booster shots for all adults
The U.S. has approved one other antiviral drug for COVID-19, remdesivir, and authorized three antibody therapies that help the immune system fight the virus. But they usually have to be given via time-consuming infusions by health professionals, and limited supplies were strained by the last surge of the delta variant.
The U.S. government has already committed to purchasing Merck’s pill. Federal authorities were in negotiations with Pfizer to buy millions of doses of its pill, according to an official familiar with the matter.
Pfizer agrees to let other companies make its COVID-19 pill
Drugmaker Pfizer Inc. has signed a deal with a U.N.-backed group to allow other manufacturers to make its experimental COVID-19 pill, a move that could make the treatment available to more than half of the world’s population.
In a statement issued Tuesday, Pfizer said it would grant a license for the antiviral pill to the Geneva-based Medicines Patent Pool, which would let generic drug companies produce the pill for use in 95 countries, making up about 53% of the world’s population.
The deal excludes some large countries that have suffered devastating coronavirus outbreaks. For example, while a Brazilian drug company could get a license to make the pill for export to other countries, the medicine could not be made generically for use in Brazil.
Still, health officials said the fact that the deal was struck even before Pfizer’s pill has been authorized anywhere, could help to end the pandemic quicker.
“It’s quite significant that we will be able to provide access to a drug that appears to be effective and has just been developed, to more than 4 billion people,” Esteban Burrone, head of policy at the Medicines Patent Pool, said.
Also Read: Pfizer says COVID-19 pill cut hospital, death risk by 90%
He estimated that other drugmakers would be able to start producing the pill within months, but acknowledged the agreement wouldn’t please everyone.
“We try to strike a very delicate balance between the interests of the (company), the sustainability required by generic producers and most importantly, the public health needs in lower and middle-income countries,” Burrone said.
Under the terms of the agreement, Pfizer will not receive royalties on sales in low-income countries and will waive royalties on sales in all countries covered by the agreement while COVID-19 remains a public health emergency.
Earlier this month, Pfizer said its pill cut the risk of hospitalization and death by nearly 90% in people with mild to moderate coronavirus infections. Independent experts recommended halting the company’s study based on its promising results.
Also Read: FDA paves way for Pfizer COVID-19 vaccinations in young kids
Pfizer said it would ask the U.S. Food and Drug Administration and other regulators to authorize the pill as soon as possible,
Since the pandemic erupted last year, researchers worldwide have raced to develop a pill to treat COVID-19 that can be taken at home easily to ease symptoms, speed recovery and keep people out of the hospital. At the moment, most COVID-19 treatments must be delivered intravenously or by injection.
Britain authorized the Merck’s COVID-19 pill earlier this month, and it is pending approval elsewhere. In a similar deal with the Medicines Patent Pool announced in October, Merck agreed to let other drugmakers make its COVID-19 pill, molnupiravir, available in 105 poorer countries.
Doctors Without Borders said it was “disheartened” that the Pfizer deal does not make the drug available to the entire world, noting that the agreement announced Tuesday also excludes countries including China, Argentina and Thailand.
“The world knows by now that access to COVID-19 medical tools needs to be guaranteed for everyone, everywhere, if we really want to control this pandemic,” said Yuanqiong Hu, a senior legal policy adviser at Doctors Without Borders.
The decisions by Pfizer and Merck to share their COVID-19 drug patents stands in stark contrast to the refusal of Pfizer and other vaccine-makers to release their vaccine recipes for wider production. A hub set up by the World Health Organization in South Africa intended to share messenger RNA vaccine recipes and technologies has not enticed a single pharmaceutical to join.
Fewer than 1% of Pfizer’s COVID-19 shots have gone to poorer countries.
FDA paves way for Pfizer COVID-19 vaccinations in young kids
The Food and Drug Administration on Friday paved the way for children ages 5 to 11 to get Pfizer's COVID-19 vaccine.
The FDA cleared kid-size doses — just a third of the amount given to teens and adults — for emergency use, and up to 28 million more American children could be eligible for vaccinations as early as next week.
One more regulatory hurdle remains: On Tuesday, advisers to the Centers for Disease Control and Prevention will make more detailed recommendations on which youngsters should get vaccinated, with a final decision by the agency’s director expected shortly afterwards.
“The rationale here is protect your children so that they can get back towards normal life,” said FDA vaccine chief Dr. Peter Marks. “The tremendous cost of this pandemic has not just been in physical illness, it’s been in the psychological, the social development of children” too.
Also read: Merck agrees to let other drug makers make its COVID pill
A few countries have begun using other COVID-19 vaccines in children under 12, including China, which just began vaccinations for 3-year-olds. But many that use the vaccine made by Pfizer and its partner BioNTech are watching the U.S. decision, and European regulators just began considering the companies' kid-size doses.
With FDA's action, Pfizer plans to begin shipping millions of vials of the pediatric vaccine — in orange caps to avoid mix-ups with the purple-capped doses for everyone else — to doctors' offices, pharmacies and other vaccination sites. Once the CDC issues its ruling, eligible kids will get two shots, three weeks apart.
While children are at lower risk of severe illness or death from COVID-19 than older people, 5- to 11-year-olds still have been seriously affected -- including over 8,300 hospitalizations, about a third requiring intensive care. The FDA said 146 deaths have been reported in that age group.
And with the extra-contagious delta variant circulating, the government has counted more than 2,000 coronavirus-related school closings just since the start of the school year, affecting more than a million children.
“With this vaccine kids can go back to something that’s better than being locked at home on remote schooling, not being able to see their friends,” said Dr. Kawsar Talaat of Johns Hopkins University. “The vaccine will protect them and also protect our communities.”
The American Academy of Pediatrics also applauded FDA’s decision, and said pediatricians were “standing by” to talk with parents.
Also read: US financing body, Biological E finalise agreement to expand COVID manufacturing capabilities in India
Vaccinating this age group is “an important step in keeping them healthy and providing their families with peace of mind,’’ said Dr. Lee Savio Beers, the academy’s president.
Earlier this week, FDA's independent scientific advisers voted that the pediatric vaccine's promised benefits outweigh any risks. But several panelists said not all youngsters will need to be vaccinated, and that they preferred the shots be targeted to those at higher risk from the virus.
Nearly 70% of 5- to 11-year-olds hospitalized for COVID-19 in the U.S. have other serious medical conditions, including asthma and obesity, according to federal tracking. Additionally, more than two-thirds of youngsters hospitalized are Black or Hispanic, mirroring long-standing disparities in the disease's impact.
The question of how broadly Pfizer's vaccine should be used will be a key consideration for the CDC and its advisers, who set formal recommendations for pediatricians and other medical professionals.
A Pfizer study of 2,268 schoolchildren found the vaccine was nearly 91% effective at preventing symptomatic COVID-19 infections, based on 16 cases of COVID-19 among kids given dummy shots compared to just three who got vaccinated.
The FDA ultimately assessed more children — 3,100 — who received the kid dosage to conclude it was safe. Youngsters experienced similar or fewer temporary reactions — such as sore arms, fever or achiness — that teens experience.
But the study wasn’t large enough to detect any extremely rare side effects, such as the heart inflammation that occasionally occurs after the second full-strength dose, mostly in young men and teen boys. It's unclear if younger children getting a smaller dose also will face that rare risk. FDA pledged Friday to keep a close watch.
Some parents are expected to vaccinate their children ahead of family holiday gatherings and the winter cold season.
Laura Cushman of Salt Lake City plans to get her three children — ages 7, 9 and 11 — vaccinated as soon as possible.
“We just want them to get to resume their pre-COVID life a little bit more. And feel safe about it,” she said.
But a recent Kaiser Family Foundation survey suggests most parents won't rush to get the shots. About 25% of parents polled earlier this month said they would get their children vaccinated “right away.” But the remaining majority of parents were roughly split between those who said they will wait to see how the vaccine performs and those who said they “definitely” won't have their children vaccinated.
The similarly made Moderna vaccine also is being studied in young children, and both Pfizer and Moderna also are testing shots for babies and preschoolers.