Tag Archives: FDA

FDA approves Amgen drug for lung cancer with specific mutation

By Deena Beasley

(Reuters) -The U.S. Food and Drug Administration on Friday approved an Amgen Inc drug for lung cancer patients with a specific mutation in a gene known as KRAS whose disease has worsened after treatment with chemotherapy or other medicines.

The drug, sotorasib, which will be sold under the brand name Lumakras, shrank tumors with the KRAS mutation in around 36% of patients in clinical trials.

The medication is designed to target a gene mutation known as KRAS G12C that occurs in about 13% of non-small cell lung cancers (NSCLC), the most common type of lung cancer.

Amgen estimates that around 25,000 U.S. patients a year will be eligible for the drug. The KRAS mutation is also found in 1% to 3% of colorectal and other cancers.

Lumakras is part of a growing trend of precision medicines that target gene mutations driving cancer regardless of which organ the disease originated.

“Today’s approval represents a significant step towards a future where more patients will have a personalized treatment approach,” Richard Pazdur, director of the FDA’s Oncology Center of Excellence, said in a statement.

Amgen said the drug will have U.S. list price of $17,900 per month. Wall Street analysts, on average, expect 2022 sales of $240 million, according to Refinitiv data.

Shares of Amgen were up $3, or 1.3%, at $238.35 in late trading on Nasdaq.

The approval, which comes more than two months before the FDA’s target decision date, is for a daily 960 milligram pill.

The agency is also requiring Amgen to conduct a post-approval study to see if a lower dose could be effective.

Cancer drugs are typically developed at the highest tolerable dose, but some oncologists have urged the FDA to do more to require drugmakers to optimize dosing.

“Our sense is this is going to become more common in oncology,” Amgen research chief David Reese told Reuters in a phone interview.

He said Amgen is studying Lumakras in combination with other drugs as an initial treatment for NSCLC patients who have the KRAS mutation, as well as for other types of cancer.

Amgen is also seeking regulatory approval of the drug in Europe, Japan and several other jurisdictions, he said.

Other companies, including Mirati Therapeutics Inc, are also developing cancer drugs targeting KRAS mutations.

(Reporting by Deena Beasley in Los Angeles; Editing by Bill Berkrot and Marguerita Choy)

U.S. CDC panel backs COVID-19 vaccine now cleared for adolescents

By Michael Erman and Manojna Maddipatla

(Reuters) -U.S. states are set to begin using the vaccine from Pfizer Inc and BioNTech SE to inoculate younger adolescents against COVID-19 after advisers to the U.S. Centers for Disease Control and Prevention (CDC) backed the plan in a unanimous vote on Wednesday.

The U.S. Food and Drug Administration on Monday authorized the vaccine for children aged 12 to 15, offering relief to parents eager to get their children back to schools and summer camps, and the action by the CDC group is an important, but not required, final seal of federal regulatory approval.

Some states, including Georgia, Delaware and Arkansas, began offering the vaccine to younger teens on Tuesday.

The Advisory Committee on Immunization Practices (ACIP), which provides recommendations to the CDC, voted 14-0 to back the vaccine, after reviewing trial evidence that showed no one in the 12-15 age group who received the vaccine got COVID-19, and there were no cases of Bell’s Palsy or severe allergic reactions.

Moreover, the vaccine produced robust antibody responses in the age group and showed 100% efficacy in the trial, with no cases of symptomatic COVID-19 among the fully vaccinated adolescents.

“This will provide protection for 12 to 15 year old’s,” said Dr. Henry Bernstein, a member of the advisory committee and professor of pediatrics at Zucker School of Medicine at Hofstra/Northwell. “It will decrease transmission within their family. It will contribute to community immunity, and it allows the kids to more safely go back to camps this summer, and back for in-person school.”

About a third of all Americans have been fully-vaccinated according to the CDC data. But the pace of vaccination has slowed in the recent weeks.

The rollout of a vaccine for adolescents should help further limit the spread of the virus at a time when more contagious variants are circulating, and could shorten the road to normalcy for Americans.

“I think we should be in full school, full in-person school, in the fall,” CDC Director Rochelle Walensky said at a CNBC health summit on Tuesday.

Children have been considered by health officials as being at a lower risk for severe COVID-19, but they can still spread the virus. More than 1.5 million cases have been reported among 12- to 17-year-olds, and as more adults become vaccinated, adolescents are accounting for a higher proportion of total cases.

Adjusted for underreporting, the working group estimated 22.2 million U.S. COVID-19 infections in those aged 5 to 17.

Pfizer is running a separate trial testing the vaccine in children as young as 6-months-old, and has said it expects data on its use in 2- to 11-year-olds in September. The 2,260 participants in the 12-to-15 age group – half of whom were given placebo – were tested as an expansion of Pfizer’s more than 46,000-person trial.

The committee will hear from Pfizer about the vaccine’s safety and efficacy in adolescents and will consider the views of a handful of CDC officials on its implementation.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Caroline Humer, Peter Henderson and Bill Berkrot)

U.S. FDA advisory panel to meet on COVID-19 vaccines in children

(Reuters) -The U.S. Food and Drug Administration said on Monday it will hold a meeting of its independent panel of advisers on June 10 to discuss the use of COVID-19 vaccines in children.

The committee will not discuss any specific products, the agency said. FDA spokesperson Stephanie Caccomo said the meeting has nothing to do with Pfizer Inc and BioNTech SA’s request to expand the U.S. Emergency Use Authorization (EUA) of their vaccine into younger children.

That vaccine is currently authorized for use in people 16 or older in the United States. The vaccine makers have asked to expand that authorization to children as young as 12, and Pfizer said last week it expects the FDA response soon.

The FDA said last month it did not plan to hold an advisory committee meeting for the Pfizer-BioNTech expansion.

“As with the initial COVID-19 vaccine authorizations, we want to ensure that the public has a clear understanding of our expectations for the data and information needed to support requests for emergency use authorization and biologics license applications for vaccines intended to prevent COVID-19 in this pediatric age range,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

(Reporting Kalluvilaby Manojna Maddipatla in Bengaluru and Michael Erman in New York; Editing by Sriraj)

U.S. to share up to 60 million AstraZeneca vaccine doses globally: White House

By Andrea Shalal

WASHINGTON (Reuters) – The United States will start to share up to 60 million doses of AstraZeneca Plc’s coronavirus vaccine with other countries as soon as the next few weeks, the White House said on Monday.

White House Press Secretary Jen Psaki said the United States would release the doses to other countries as they become available.

She said there could be 10 million doses cleared for export “in coming weeks.” About 50 million more doses are currently being produced and could ship in May and June.

“Right now we have zero doses available of AstraZeneca,” Psaki said, noting that U.S. regulators still need to review the quality of those already produced.

Psaki said the Biden administration is still deciding what the process will be to determine where and how it will share the vaccine.

“We will consider a range of options from our partner countries and, of course, much of that will be through direct relationships,” she said.

The AstraZeneca vaccine has not yet been authorized for U.S. use by the Food and Drug Administration.

The Biden administration in March said it would send roughly 4 million doses of the British drugmaker’s vaccine to Canada and Mexico, and is under growing pressure now to expand sharing of its stockpile with India and other countries.

India has become the latest epicenter of the pandemic, threatening to overwhelm its healthcare system.

An AstraZeneca spokeswoman could not comment on specifics of the arrangement, but said the doses were part of its supply commitments to the U.S. government. “Decisions to send U.S. supply to other countries are made by the U.S. government,” she said.

The Associated Press earlier on Monday reported the doses would be shared in coming months following their clearance by the FDA.

The AP reported that the doses were made at the Emergent BioSolutions facility in Baltimore, which came under harsh criticism for a long list of cleanliness and manufacturing problems found during an FDA inspection.

AstraZeneca is no longer making vaccine at that plant after a batch of Johnson & Johnson’s vaccine was ruined by contamination with ingredients from the AstraZeneca shot.

J&J is now overseeing production of its vaccine at the Emergent plant.

(Additional reporting by Susan Heavey, Caroline Humer and Michael Erman; Editing by Tim Ahmann and Bill Berkrot)

U.S. pauses J&J COVID-19 vaccine over rare blood clots

By Manas Mishra and Michael Erman

(Reuters) – U.S. federal health agencies on Tuesday recommended pausing the use of Johnson & Johnson’s COVID-19 vaccine after six women under 50 developed rare blood clots after receiving the shot, dealing a fresh setback to efforts to tackle the pandemic.

The move comes a week after European regulators said they had found a possible link between AstraZeneca’s COVID-19 vaccine and a similar rare blood clotting problem that led to a small number of deaths.

Johnson & Johnson’s (J&J) single dose vaccine – most COVID-19 shots are delivered over two doses – and AstraZeneca’s low-cost vaccine are seen as vital tools in the fight against a pandemic that has claimed more than three million lives.

Most of the available J&J vaccine has been used in the United States due to production issues that have limited the company’s supply. As of April 12, more than 6.8 million doses of the J&J vaccine had been administered in the United States, compared with more than 180 million shots combined of the Moderna and Pfizer/BioNTech shots.

An advisory committee to the U.S. Centers for Disease Control and Prevention (CDC) will meet on Wednesday to review the cases, and the U.S. Food and Drug Administration (FDA) will review the analysis, the agencies said in a joint statement.

All six cases involved women between the ages of 18 and 48, and the symptoms occurred six to 13 days after vaccination.

In the cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).

The CDC and FDA said the adverse events appeared to be extremely rare.

“I think this is a very low risk issue, even if causally linked to the vaccine: 6 cases with about 7 million doses (lower than the risk of clots with oral contraceptives) is not something to panic about,” Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security in Baltimore, said in an email.

“People are asking me if they should cancel their J&J vaccine appointments and I have told them not to but I know many will and this will stall progress in controlling the pandemic.”

J&J said it was working closely with regulators and noted no clear causal relationship had been established between the cases and the COVID-19 vaccine made by its Janssen unit.

One woman died and a second in Nebraska has been hospitalized in a critical condition, the New York Times reported, citing officials.

‘ABUNDANCE OF CAUTION’

“The FDA recommendation to pause the administration of the Johnson and Johnson vaccine out of an abundance of caution makes sense in terms of the nature of the unusual and serious side effect not seen with the other vaccines,” said Dr. Robert Klugman at the UMass Memorial Medical Center in Massachusetts in an email.

“While the incidence is very low, the severity and potential for brain damage and other blood clot-related injuries is of great concern.”

J&J’s shares were down 3% before the opening bell.

The U.S. move comes less than a week after Europe’s drugs regulator said it was reviewing rare blood clots in four people in the United States who had received the J&J shot.

The J&J and AstraZeneca vaccines both use an adenovirus vector – a harmless cold virus that instructs human cells to produce a protein found on the surface of the coronavirus, thereby spurring the immune system to prepare an arsenal against the COVID-19-causing virus.

Among leading global COVID-19 vaccine developers, China’s CanSino Biological and Russia’s Gamaleya Institute with its Sputnik V vaccine are also relying on this approach. The Pfizer/BioNtech and Moderna vaccines use mRNA technology.

The rollout of J&J’s vaccine has been slowed by issues at production plants.

The company has supplied the United States with at least 20 million doses but is behind schedule on its deliveries. Problems at a Baltimore, Maryland plant run by outside contractor Emergent BioSolutions forced the companies to trash a batch of vaccine substance.

The plant – meant to be one of J&J’s main U.S. manufacturing facilities – has yet to be approved by U.S. regulators to supply vaccine doses, and J&J shipments to the states were expected to fall sharply next week.

J&J only began delivering its COVID-19 vaccine to European Union countries this week. It has committed to delivering 55 million doses to the bloc by the end of June and another 120 million in the third quarter.

J&J has been doing vaccinations in South Africa to study the effects on health workers, and had vaccinated just under 300,000 people there as of Monday, according to data from the country’s health department. J&J recently struck a deal with the African Union for up to 400 million doses.

Europe’s drugs regulator continues to recommend the use of AstraZeneca’s COVID-19 vaccine, saying the benefits outweigh the risks. Several EU countries, however, have limited its use to certain age groups.

Australia has no current plans to add J&J’s coronavirus vaccine to its immunization drive, authorities said on Tuesday, as it moves away from procuring vaccines under review for potential links to blood clots.

(Reporting by Manas Mishra in Bengaluru and Michael Erman in Maplewood, N.J., additional reporting by Julie Steenhuysen in Chicago and Ludwig Burger in Frankfurt; Editing by Sriraj Kalluvila and Mark Potter)

FDA advisory panel to review Johnson & Johnson COVID-19 vaccine with thumbs up expected

By Manas Mishra and Michael Erman

(Reuters) – A panel of expert advisers to the U.S. Food and Drug Administration began a meeting to discuss Johnson & Johnson’s one-dose COVID-19 vaccine on Friday, setting the stage for a possible emergency use authorization as early as this week.

After it receives the recommendation, the FDA is likely to authorize the vaccine for emergency use within a day or so, making it the third available in the United States, and the only one that requires just one shot.

The panel, consisting of doctors, infectious disease experts and medical researchers, began the meeting at 9:00 a.m. ET (1400 GMT), and will vote in favor or against the vaccine’s use several hours later at the end of the meeting.

The panel will consider whether the benefits of the vaccine outweigh its risk for use in people aged 18 and older.

In a 44,000-person trial, the vaccine overall was 66% effective at preventing moderate-to-severe cases of COVID-19 compared with a placebo.

The effectiveness of the one-dose vaccine varied over time and location. In the United States, the effectiveness was 74% at 14 days and 72% two weeks later, while the shot was 64% effective at stopping moderate-to-severe COVID-19 after 28 days in South Africa, where a worrying new variant has swept across the country.

The vaccine was 100% effective at preventing hospitalizations 28 days after vaccination and there were no COVID-19 deaths among those who received the shot.

“In the context of the pandemic, the FDA is likely to issue an emergency use authorization (EUA) based on the data,” said UBS analyst Navin Jacob ahead of the panel meeting.

The J&J vaccine can be stored in normal refrigerator temperatures, making distribution easier than that of the Pfizer Inc/BioNTech SE and Moderna Inc vaccines that use mRNA technology and must be shipped and stored frozen.

J&J’s vaccine uses a common cold virus known as adenovirus type 26 to introduce coronavirus proteins into cells in the body and trigger an immune response.

Three to four million doses of the vaccine are expected to be rolled out next week.

(Reporting by Manas Mishra in Bengaluru and Michael Erman in New York; Editing by Caroline Humer, Bill Berkrot and Shounak Dasgupta)

Johnson & Johnson’s one-shot COVID-19 vaccine effective and safe: FDA staff

(Reuters) – Johnson & Johnson’s one-shot COVID-19 vaccine appeared safe and effective in trials, U.S. Food and Drug Administration (FDA) staff said in documents published on Wednesday, paving the way for its approval for emergency use.

The FDA’s panel of independent experts meets on Friday to decide whether to approve the shot. While it is not bound to follow the advice of its experts, the FDA usually does and has authorized vaccines from Pfizer and Moderna.

J&J said in documents submitted to the FDA that its data suggested its vaccine was effective at preventing asymptomatic infections. It said that in a preliminary analysis of its trial, it found 16 cases of asymptomatic cases in the placebo group versus two in the vaccine group, or an 88% efficacy rate.

While asymptomatic infection was not the primary goal of the trial, which studied the vaccine’s ability to stop moderate to severe COVID-19, the reduction of asymptomatic cases implies the shot can also cut transmission of the disease.

J&J’s vaccine was 66% effective in preventing COVID-19 against multiple variants in a global trial involving nearly 44,000 people, the company said last month.

Its effectiveness varied from 72% in the United States to 66% in Latin America and 57% in South Africa, where a new variant has spread, though the vaccine was 85% effective overall in stopping severe cases of the disease.

The vaccine was effective in reducing the risk of COVID-19 and preventing PCR-test confirmed COVID-19 at least 14 days after vaccination, the FDA said in its briefing documents.

Fourteen days after injection, only two vaccine recipients developed COVID-19 severe enough to need medical intervention, compared with 14 in the placebo group. After 28 days, no vaccine recipients developed COVID severe enough to require medical intervention whereas seven in the placebo group did.

Three vaccine recipients had severe side effects in the trial that were likely related to the vaccine, but the FDA said its analysis did not raise any specific safety concerns that would preclude issuance of an emergency use authorization.

The FDA said the most common solicited adverse reactions were injection site pain at 48.6%, headache at 39%, fatigue at 38.2% and myalgia at 33.2%. Other side effects included a fever in 9% of participants and a high fever in 0.2% of those who received the vaccine.

The regulator said one case of pericarditis, a heart disease, may have been caused by the vaccine. It said cases of a rare disorder, Guillain-Barre Syndrome, were unlikely to be related to the shot though data was insufficient to determine whether or not the vaccine had caused these side effects.

J&J had not previously released details of its clinical trial data beyond efficacy rates.

(Reporting by Manas Mishra in Bengaluru; Mike Erman, Caroline Humer and Rebecca Spalding; Editing by Bernard Orr and David Clarke)

Trials of retooled vaccines for variants could take months: U.S. FDA

By Michael Erman

(Reuters) – Drugmakers should test any COVID-19 vaccines that have been retooled to combat new variants of the coronavirus in clinical trials designed to track the immune response of hundreds of test subjects, which could take months, U.S. regulators said on Monday.

Vaccine developers may need to modify their shots to provide protection against new variants of the coronavirus that turn up in the United States should they fail to elicit immune response in their current form, the U.S. Food and Drug Administration said in a statement.

The FDA said it believes currently authorized vaccines from Pfizer Inc with partner BioNTech SE and Moderna Inc. are effective against variants currently circulating in the United States.

Acting FDA Commissioner Janet Woodcock said drugmakers should not wait until a mutated virus is demonstrated to be able to escape the vaccines to begin developing new versions.

“We need to anticipate this and work on it, so that we have something in our back pocket before the threshold is upon us,” she said at a news conference.

The emergence of new, more contagious variants has prompted the U.S. government to step up efforts to track coronavirus mutations and try to keep vaccines and treatments effective against any new variants.

Pfizer and Moderna have both said they plan to run clinical trials of versions of their vaccine that have been redesigned to combat the highly contagious COVID-19 variant that has become prevalent South Africa and has turned up in several U.S. States.

The FDA made the comments as part of a newly updated guidance for companies making vaccines, tests and therapeutics for COVID-19.

As part of its updated guidance, the FDA recommended that vaccine makers test any modified vaccines in both previously unvaccinated people and vaccinated people. The manufacturers should compare the immune response of a modified vaccine against both the new variant as well as the original virus.

The FDA also recommended monitoring test subjects’ safety for at least seven days, to support emergency use authorization for modified vaccines.

The agency is trying to allow drugmakers to make the change with a minimal amount of extra data needed, said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

Still, the type of trial the agency wants, “might take a few months, whether it be two or three,” Marks said. “I can’t say exactly how long but again, that type of the scale of the amount of time.”

“We want to be ready so that we can move it into production, when it’s ready and when it’s needed,” he said.

(Additional reporting by Manojna Maddipatla and Mrinalika Roy in Bengaluru; Editing by Jonathan Oatis and Bill Berkrot)

Pfizer wants to store vaccine at higher temperatures, making deliveries easier

FRANKFURT (Reuters) – Pfizer Inc and BioNTech SE have asked the U.S. health regulator to relax requirements for their COVID-19 vaccine to be stored at ultra-low temperatures, potentially allowing it to be kept in pharmacy freezers, they said on Friday.

Approval by the Food and Drug Administration (FDA) could send a strong signal to other regulators around the world that may ease distribution of the shot in lower-income countries.

The companies have submitted new temperature data to the FDA to support an update to the current label that would allow vials to be stored at -25 to -15 degrees Celsius (-13°F to 5°F) for a total of two weeks.

The current label requires the vaccine to be stored at temperatures between -80ºC and -60ºC (-112ºF to -76ºF), meaning it has to be shipped in specially designed containers.

The shot’s cold-storage requirements set off a scramble among U.S. states at the beginning of the rollout for dry ice, in which it can be stored temporarily when there are no specialized freezers available, for instance in rural areas.

Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security, said the higher temperatures should “greatly expand the ability to use this vaccine in many parts of the world (or even the U.S.) that do not have the capacity for deep freeze storage”.

Pfizer/BioNTech’s vaccine, along with Moderna Inc’s two-dose shot, has already won U.S. emergency-use authorization and is being widely distributed as part of the country’s mass vaccination efforts.

The update from the drugmakers comes as two studies from Israel found that the vaccine greatly reduced virus transmission, and the shot was backed by two of the South African government’s top advisers.

The new data also will be submitted to global regulatory agencies within the next few weeks, the two companies said.

A BioNTech spokeswoman declined to provide more details on the timing and which agencies would be contacted.

“The data submitted may facilitate the handling of our vaccine in pharmacies and provide vaccination centers an even greater flexibility,” BioNTech Chief Executive Ugur Sahin said.

Deutsche Post, which has shipped COVID-19 vaccines to several European countries, Israel, Bahrain, Mexico and Singapore, among other states, said -25 degrees would provide some relief but transportation would still not be easy.

A spokeswoman said air freight would likely no longer require dry ice on board, increasing storage capacity per plane.

BioNTech has said it imposed long-term storage and transportation requirements of -70 degrees out of caution because it had started stability and durability tests on its vaccine relatively late.

Even though it launched its COVID-19 vaccine development program as early as January 2020, working on four compounds in parallel, it did not decide until July which of the four to proceed with, and only then started stability tests.

If approved, the less onerous storage requirements would provide significant logistical relief.

The World Health Organization’s COVAX global vaccine-sharing program has so far limited distribution of Pfizer-BioNTech vaccines to just a few countries, partly out of concern over a lack of infrastructure in developing nations.

The WHO said it was hopeful that eased requirements could broaden its reach.

“We are aware of reports of this and look forward to seeing the data. If proven correct, this could make rollout of the vaccine easier in all countries, and particularly in low-income ones,” it said.

Moderna’s product, which like Pfizer’s is based on so-called messenger RNA molecules, is already cleared for storage at -25 to -15 degrees Celsius.

(Reporting by Manojna Maddipatla and Ankur Banerjee in Bengaluru, Ludwig Burger in Frankfurt, John Miller in Zurich, Matthias Inverardi in Duesseldorf, Michael Erman in Maplewood, N.J. and Lisa Baertlein in Los Angeles; Editing by Shounak Dasgupta, Anil D’Silva, Jan Harvey and Nick Macfie)

High levels of toxic heavy metals found in some baby foods: report

WASHINGTON (Reuters) – U.S. congressional investigators found “dangerous levels of toxic heavy metals” in certain baby foods that could cause neurological damage, a House Oversight subcommittee said in a report released on Thursday.

The panel examined baby foods made by Nurture Inc, Hain Celestial Group Inc, Beech-Nut Nutrition and Gerber, it said, adding that it was “greatly concerned” that Walmart Inc, Campbell Soup Co and Sprout Organic Foods refused to cooperate with the investigation.

The report said internal company standards “permit dangerously high levels of toxic heavy metals, and documents revealed that the manufacturers have often sold foods that exceeded those levels.”

Campbell said in a statement on its website that its products are safe and cited the lack of a current FDA standard for heavy metals in baby food. The company said it thought it had been “full partners” in the study with congressional researchers.

Walmart did not immediately respond to a request for comment. Hain could not immediately be reached for comment.

The report was critical also of the administration of then-President Donald Trump, saying it “ignored a secret industry presentation to federal regulators revealing increased risks of toxic heavy metals in baby foods.”

The report said “in 100% of the Hain baby foods tested, inorganic arsenic levels were higher in the finished baby food than the company estimated they would be based on individual ingredient testing.”

It said that in August 2019 the FDA received a secret slide presentation from Hain that said “corporate policies to test only ingredients, not final products, under represent the levels of toxic heavy metals in baby foods.”

The report said the FDA took no new action in response. “To this day, baby foods containing toxic heavy metals bear no label or warning to parents. Manufacturers are free to test only ingredients, or, for the vast majority of baby foods, to conduct no testing at all,” the report said.

The Food and Drug Administration (FDA) has declared that inorganic arsenic, lead, cadmium, and mercury are dangerous, particularly to infants and children. They have “no established health benefit” and “lead to illness, impairment, and in high doses, death.”

(Reporting by Susan Heavey and David Shepardson; Editing by Howard Goller)