Tag Archives: U.S. Food and Drug Administration

U.S. to announce new warning on J&J coronavirus vaccine for autoimmune disorder -Washington Post

(Reuters) -The U.S. Food and Drug Administration is expected to announce a new warning on Johnson & Johnson’s coronavirus vaccine related to a rare autoimmune disorder, the Washington Post reported on Monday, citing four people familiar with the matter.

According to the Post, about 100 preliminary reports of Guillain-Barré syndrome (GBS) have been detected in the United States after vaccination with J&J shot, mostly in men, many of whom were 50 or older. Around 12.8 million people have received the one-dose vaccine in the United States.

J&J and the FDA were not immediately available for comment.

GBS is a rare neurological condition in which the body’s immune system attacks the protective coating on nerve fibers. Most cases follow a bacterial or viral infection.

The condition has been linked in the past to vaccinations – most notably to a vaccination campaign during a swine flu outbreak in the United States in 1976, and decades later to the vaccine used during the 2009 H1N1 flu pandemic.

Last week, European regulators recommended a similar warning for AstraZeneca’s COVID-19 shot, which is based on a similar technology as Johnson & Johnson’s vaccine.

A warning would be another setback for the J&J shot, which was supposed to be an important tool for vaccinating in hard-to-reach areas and the vaccine hesitant 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 use of the vaccine has already been linked to very rare, potentially life threatening blood clotting condition and slowed by production problems at the main plant where it is being made.

U.S. regulators decided in April that the vaccine’s benefits outweigh the risk from the blood clotting issue.

(Reporting by Lisa Lambert in Washington and Michael Erman in New Jersey; Editing by Chris Reese and Peter Graff)

U.S. FDA set to authorize Pfizer COVID-19 shot for ages 12-15 early next week – NYT

(Reuters) – The U.S. Food and Drug Administration is preparing to authorize Pfizer Inc and German partner BioNTech SE’s COVID-19 vaccine for adolescents aged between 12 and 15 years by early next week, the New York Times reported on Monday, citing federal officials familiar with the agency’s plans.

An approval is highly anticipated after the drugmakers said in March that the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year-olds in a clinical trial.

Responding to a Reuters request for comment, the FDA said its review of expanding the vaccine’s emergency use authorization is ongoing, but did not provide further details.

The vaccine has already been cleared in the United States for people aged 16 and above.

Pfizer declined to comment on the NYT report.

The U.S. Centers for Disease Control (CDC) Director Rochelle Walensky said earlier in April that the vaccine could be approved by mid-May.

If an approval for the 12-15 year old’s is granted, the CDC’s vaccine advisory panel will likely meet the following day to review the clinical trial data and make recommendations for the vaccine’s use in adolescents, the report added.

A potential approval of the vaccine would boost the country’s immunization drive and help allay fears of parents anxious to protect their children from COVID-19.

Moderna Inc and Johnson & Johnson are also testing their vaccines in 12- to 18-year old’s, with data from Moderna’s trial expected to come soon.

Pfizer and Moderna have also launched trials in even younger children, aged six months to 11 years old. Both companies have said they hope to be able to vaccinate children under 11 as soon as early 2022.

(Reporting by Trisha Roy in Bengaluru; Editing by Devika Syamnath)

Q&A: Where are we in the COVID-19 vaccine race?

(Reuters) – Drugmakers and research centers around the world are working on COVID-19 vaccines, with large global trials of several of the candidates involving tens of thousands of participants well underway.

The following is what we know about the race to deliver vaccines to help end the coronavirus pandemic that has claimed over 1.26 million lives worldwide:

Who is furthest along?

U.S. drugmaker Pfizer Inc and German partner BioNTech SE were the first to release data showing on Monday that their vaccine worked in a large, late-stage clinical trial.

Russia’s sovereign wealth fund published interim late-stage trial results for its Sputnik V vaccine on Wednesday showing the shot is 92% effective at protecting people from COVID-19.

The next data releases will likely be from U.S. biotech firm Moderna Inc, possibly in November, and from Britain-based AstraZeneca Plc with the University of Oxford in November or December. Johnson & Johnson says it is on track to deliver data this year.

What happens in these trials?

The companies are testing their vaccines against a placebo – typically saline solution – in healthy volunteers to see if the rate of COVID-19 infection among those who got the vaccine is significantly lower than in those who received the dummy shot.

Why is Pfizer ahead with its data?

The trials rely on subjects becoming naturally infected with the coronavirus, so how long it takes to generate results largely depends on how pervasive the virus is where trials are being conducted. Each drugmaker has targeted a specific number of infections to trigger a first analysis of their data.

Pfizer said its interim analysis was conducted after 94 participants in the trial developed COVID-19 while Russia’s examination was conducted after 20 participants in the trial developed the disease.

AstraZeneca said last week a slowdown in infections during the summer is delaying data analysis for its UK trial.

COVID-19 cases, however, soared in October and early November, setting daily records in the United States and Europe.

How well are the vaccines supposed to work?

The World Health Organization has recommended a minimum standard for effectiveness of at least 50%. The United States and some other regulators are following that guideline – which means there must be at least twice as many infections among volunteers who received a placebo as among those in the vaccine group. The European Medicines Agency has said it may accept a lower efficacy level.

Pfizer and Russia both said their vaccines are more than 90% effective against COVID-19.

When will regulators rule on safety and efficacy?

Regulators review vaccines after companies submit applications seeking either emergency use authorization (EUA) or formal approval.

The earliest the U.S. Food and Drug Administration could make a decision is in December because Pfizer/BioNTech and Moderna do not expect to have enough safety data until the second half of November. The FDA has asked companies to watch trial participants for side effects for two months after receiving a final vaccine dose.

Regulators for Europe, the United Kingdom and Canada are considering data on a rolling basis, as it becomes available. They expect to conduct expedited reviews as well. It is not clear when companies will submit efficacy data to these agencies or when the agencies would make a decision.

Could these be the first widely available coronavirus vaccines?

Yes, although China is on a similar timeline. The country launched an emergency use program in July aimed at essential workers and others at high risk of infection that has vaccinated hundreds of thousands of people.

At least four vaccines are far along including those from China National Biotec Group (CNBG), CanSino Biologics and Sinovac. Sinovac and CNBG have said to expect early trial data as soon as November.

Russia has also given the Sputnik V vaccine developed by the Gamaleya Institute to 10,000 members of the general population considered at high risk of contracting the virus.

In late October, the director of the Gamaleya Institute, Alexander Gintsburg, said 20,000 volunteers had received the first shot so far and 9,000 the second.

(Reporting by Carl O’Donnell in New York; Additional reporting by Julie Steenhuysen in Chicago, Michael Erman in New York, Ludwig Burger in Frankfurt, Alistair Smout in London and Polina Ivanova in Moscow; Editing by Caroline Humer, Bill Berkrot, Edwina Gibbs, David Clarke and Josephine Mason)

U.S. has a plan to start Pfizer vaccine shots in December: Health Secretary Azar

By Doina Chiacu and Deena Beasley

WASHINGTON (Reuters) – If Pfizer Inc. submits the positive initial data from its COVID-19 vaccine trial to health regulators as quickly as expected, the U.S. government plans to begin vaccinating Americans in December, Health Secretary Alex Azar said on Tuesday.

Pfizer on Monday said the vaccine it has been developing with German partner BioNTech SE was 90% effective against COVID-19, based on an early look at results from its large, late-stage trial.

The U.S. drugmaker said it expects to have safety data as soon as next week that it needs to apply for emergency use authorization (EUA) with the U.S. Food and Drug Administration.

Upon FDA authorization, the United States would receive about 20 million doses of the Pfizer vaccine per month, Azar said on a call with reporters, noting that HHS could being procuring supplies at the end of this month.

The United States has a $1.95 billion contract for 100 million doses of the Pfizer vaccine – enough to inoculate 50 million people – with an option to acquire 500 million more.

Earlier on Tuesday, Azar said on CNBC that final decisions are subject to a close look at the vaccine efficacy data.

Based on recommendations to the government, it will likely start with inoculations of the elderly in nursing homes and assisted living facilities, healthcare workers and first responders, with a goal to complete those shots by the end of January.

Top U.S. infectious disease expert Anthony Fauci also said in an interview with MSNBC that he expects the doses of the vaccine to be available for certain high priority groups in December.

Azar said he anticipates there will soon be more vaccines to protect against COVID-19 from other companies, including Moderna Inc <MRNA.O>, which is expected to announce interim results of a large trial of its experimental vaccine at the end of the month.

“By the end of March, early April, we expect to have enough for every American who would like to be vaccinated,” Azar told CBNC.

ANTIBODY DRUG DISTRIBUTION

Azar also said the U.S. government would begin distribution of Eli Lilly and Co’s antibody treatment this week, starting first in areas with the highest numbers of hospitalized COVID-19 patients and overall cases.

The treatment, which is administered by infusion, received an EUA on Monday.

“We’ll ensure equitable distribution, and we’ll work tightly with our governors,” Azar said. He said the government will use the same process employed to distribute remdesivir, an antiviral drug from Gilead Sciences Inc used to treat people hospitalized with COVID-19.

According to the Health and Human Services website, the agency will ship more than 79,000 doses of the antibody therapy this week, with the largest number going to Wisconsin, Texas, California, and Illinois.

The United States has purchased 300,000 doses of the treatment for this year and has an option to buy an additional 650,000 doses next year.

Azar said health officials and Eli Lilly were exploring ways to provide the treatment outside of hospitals, including through outpatient infusion centers.

Fauci described the Lilly treatment as “an important first step in the development and distribution of interventions that are given early in the course of disease.”

(Reporting by Doina Chiacu in Washington, Caroline Humer and Carl O’Donnell in New York, Deena Beasley in Los Angeles and Manojna Maddipatla in Bengaluru; Editing by Andrew Heavens, Alexandra Hudson and Bill Berkrot)

FDA’s emergency approval of blood plasma as COVID-19 treatment on hold: NYT

(Reuters) – The emergency approval of blood plasma as a potential COVID-19 treatment by the U.S. Food and Drug Administration has now been put on hold, the New York Times reported on Wednesday, citing two senior administration officials.

A group of top federal health officials including Anthony Fauci have argued that the emerging data on the treatment was too weak, the report said, adding that an emergency approval could still be granted in the near future.

The authorization is on hold for now as more data is reviewed, the NYT reported, citing Clifford Lane, the clinical director at the National Institute of Allergy and Infectious Diseases, part of the National Institute of Health.

The FDA and NIH did not immediately respond to Reuters’ requests for comment.

People who survive an infectious disease like COVID-19 are left with blood plasma containing antibodies, or proteins the body’s immune system created, to fight off a virus. This can be transfused into newly infected patients to try to aid recovery.

An FDA emergency-use authorization could allow faster access to a therapy for the pandemic.

(Reporting by Trisha Roy in Bengaluru; Editing by Saumyadeb Chakrabarty)

U.S. FDA approves first rapid coronavirus test with 45 minutes detection time

By Kanishka Singh

(Reuters) – The U.S. Food and Drug Administration has approved the first rapid coronavirus diagnostic test, with a detection time of about 45 minutes, as the United States struggles to meet the demand for coronavirus testing.

The test’s developer, California-based molecular diagnostics company Cepheid, said on Saturday it had received an emergency use authorization from the FDA for the test, which will be used primarily in hospitals and emergency rooms. The company plans to begin shipping it to hospitals next week, it said.

The FDA confirmed its approval in a separate statement. It said the company intends to roll out the availability of its testing by March 30.

Under the current testing regime, samples must be sent to a centralized lab, where results can take days.

“With new tools like point-of-care diagnostics, we are moving into a new phase of testing, where tests will be much more easily accessible to Americans who need them,” U.S. Secretary of Health and Human Services Alex Azar said on Saturday.

The United States is not even close to meeting domestic demand for coronavirus testing. Many medical experts have predicted that delayed and chaotic testing will cost lives, potentially including those of doctors and nurses.

On Friday, Anthony Fauci, director of National Institute of Allergy and Infectious Diseases, was asked whether the United States can currently meet demand for tests.

“We are not there yet,” Fauci said.

The diagnostic test for the virus that causes COVID-19 has been designed to operate on any of Cepheid’s more than 23,000 automated GeneXpert Systems globally, the company said.

The systems do not require users to have special training to perform testing, and are capable of running around the clock, Cepheid President Warren Kocmond said in the statement.

The company did not give further details or say how much the test will cost.

The U.S. FDA has been pushing to expand screening capacity for the virus while the World Health Organization has called for “order and discipline” in the market for health equipment needed to fight the outbreak.

(Reporting by Kanishka Singh in Bengaluru; Editing by Sonya Hepinstall and Daniel Wallis)

Don’t eat romaine: U.S., Canada warn on E.coli in lettuce

FILE PHOTO - Romaine lettuce grows near Soledad, California, U.S., May 3, 2017. REUTERS/Michael Fiala

(Reuters) – Public health officials in the United States and Canada on Tuesday warned against eating romaine lettuce while they investigate an outbreak of E. coli that has sickened 50 people in the two countries, including 13 who were hospitalized.

The alerts, issued as millions of Americans plan their Thanksgiving Day menus, covered all forms of romaine, including whole heads, hearts, bags, mixes and Caesar salad.

Officials were uncertain of the source of the tainted lettuce.

“Consumers who have any type of romaine lettuce in their home should not eat it and should throw it away, even if some of it was eaten and no one has gotten sick,” the U.S. Centers for Disease Control said in its food safety alert.

Refrigerator drawers and shelves where romaine lettuce had been stored should be sanitized, the CDC said.

The Public Health Agency of Canada, which is investigating 18 of the E. coli cases, directed its romaine lettuce alert at consumers in Ontario and Quebec.

In the United States, the CDC said the outbreak affected 32 people in 11 states between Oct. 8 and 31. No deaths have been reported, it said.

Symptoms of the infection often include a moderate fever, severe stomach cramps, vomiting, and diarrhea, which is often bloody, the CDC said. Most people get better in five to seven days, but it can be life-threatening, it said.

The agency said the current outbreak is unrelated to another multi-state rash of E. coli infections related to romaine lettuce earlier this year that left five people dead and sickened nearly 200.

The U.S. Food and Drug Administration and the CDC traced the origin of that contamination to irrigation water in the Yuma, Arizona, growing region.

(Reporting by Peter Szekely in New York; Editing by David Gregorio)