Tag Archives: Johnson & Johnson

COVID-19 vaccine makers tell Congress U.S. supply will surge soon

By Michael Erman and Manojna Maddipatla

NEW YORK (Reuters) – COVID-19 vaccine makers told Congress on Tuesday that U.S. supplies should surge in the coming weeks due to manufacturing expansions and new vaccine authorizations.

Executives from Pfizer Inc, Moderna Inc and Johnson & Johnson – speaking at a hearing at the U.S. House of Representatives – said they would be able to supply enough vaccine to fully inoculate 130 million people in the United States by the end of March.

The drugmakers also reaffirmed their commitments to supply more than enough doses necessary to vaccinate all Americans by the end of July.

Pfizer Chief Business Officer John Young said it was plausible that there could be a surplus of vaccine in the United States sometime in the second quarter of this year.

“We certainly hope that we’re going to be in a position where every eligible adult will be able to receive vaccinations,” Young said.

Around 44.5 million people in the United States had received at least one dose of two-shot vaccines developed by Pfizer and BioNTech or Moderna, as of Tuesday morning.

Johnson & Johnson’s single-dose vaccine will be considered by an outside advisory committee to the U.S. Food and Drug Administration later this week, and emergency use authorization could come shortly afterward.

Richard Nettles, Vice President of Medical Affairs at J&J’s Janssen Pharmaceuticals unit, said the company would be able to ship nearly 4 million doses of its COVID-19 vaccine upon authorization and 20 million doses by the end of March.

Additional doses could also come from AstraZeneca Plc and from Novavax Inc, which are currently running clinical trials of their experimental vaccines.

An AstraZeneca executive said the drugmaker could supply doses necessary to vaccinate another 25 million people by the end of April if their vaccine is authorized by U.S. regulators.

(Reporting by Michael Erman; Editing by Bill Berkrot)

J&J adds to COVID-19 vaccine armory with 66% efficacy in global trial

By Julie Steenhuysen

(Reuters) – Johnson & Johnson said on Friday that its single-dose vaccine was 66% effective in preventing COVID-19 in a large global trial against multiple variants which will give health officials another weapon to tackle the coronavirus.

In the trial of nearly 44,000 volunteers, the level of protection against moderate and severe COVID-19 varied from 72% in the United States, to 66% in Latin America and just 57% in South Africa, from where a worrying variant has spread.

A high bar has been set by two authorized vaccines from Pfizer/BioNTech and Moderna, which were around 95% effective in preventing symptomatic illness in pivotal trials when given in two doses.

Those trials, however, were conducted mainly in the United States and before new variants emerged.

The top U.S. infectious disease specialist Anthony Fauci said the variations in effectiveness around the world underlined the need to vaccinate as many people as quickly as possible to prevent new variants from emerging.

“It’s really a wake up call for us to be nimble and to be able to adjust as this virus will continue for certain to evolve,” Fauci said.

J&J’s main goal was the prevention of moderate to severe COVID-19, and the vaccine was 85% effective in stopping severe disease and preventing hospitalization across all geographies and against multiple variants 28 days after immunization.

That “will potentially protect hundreds of millions of people from serious and fatal outcomes of COVID-19,” Paul Stoffels, J&J’s chief scientific officer, said of the results, which were based on 468 symptomatic cases.

SEEKING APPROVAL

J&J plans to seek emergency use authorization from the U.S. Food and Drug Administration next week. It has said it plans to deliver 1 billion doses in 2021 and will produce the vaccine in the United States, Europe, South Africa and India.

Public health officials are counting on the J&J vaccine to increase much-needed supply and simplify immunization in the United States, which has a deal to buy 100 million doses of J&J’s vaccine and an option for an additional 200 million.

J&J said the vaccine would be ready immediately upon emergency approval, but Stoffels declined to say how many doses.

“Right now, any protection and additional vaccine is great. The key is not only overall efficacy but specifically efficacy against severe disease, hospitalization, and death,” Walid Gellad, a health policy associate professor at the University of Pittsburgh, said.

Michael Breen, Director of Infectious Diseases and Ophthalmology at research firm GlobalData said “Most countries are still desperate to get their hands on doses, regardless of whether or not the vaccine is considered highly effective. Moderately effective will do just fine for now.”

None of the vaccine recipients in the J&J trial died from COVID-19, compared with 5 in the placebo group, the National Institutes of Health said. Three deaths in the vaccine group overall, but none were determined to be from the virus. That compares with 16 deaths overall in the placebo arm, it added.

Unlike the Pfizer and Moderna vaccines, J&J’s does not require a second shot weeks after the first or need to be kept frozen, making it a strong candidate for use in parts of the world where transportation and cold storage are an issue.

SOUTH AFRICAN VARIANT

Several studies have emerged this month showing that a South African variant has mutated in areas of the virus that are key targets of vaccines, reducing their efficacy.

“What we are learning is there is different efficacy in different parts of the world,” Stoffels told Reuters.

In a sub-study of 6,000 volunteers in South Africa, Stoffels said, the J&J vaccine was 89% effective at preventing severe disease. In the South Africa portion of the trial, 95% of cases were infections with the South African variant.

“I am overwhelmed by the fact that this vaccine protected against severe disease even in South Africa,” said Glenda Gray, the joint lead investigator of the South African vaccine trial.

Gray, who is the chief executive of the South African Medical Research Council, said this is by far the best vaccine for South Africa to fight the mutant strain and can prevent a large number of hospitalizations and deaths.

A mid-stage trial of a Novovax coronavirus vaccine in South Africa also showed lower efficacy, proving to be 60% effective among volunteers who didn’t have HIV. In a separate, late-stage trial in Britain it was 89.3% effective.

In the J&J trial, which was conducted in eight countries, 44% of participants were from the United States, 41% from Central and South America and 15% from South Africa. Slightly more than a third of the volunteers were over 60.

J&J’s vaccine uses a common cold virus to introduce coronavirus proteins into cells in the body and trigger an immune response, whereas the Pfizer/BioNTech and Moderna vaccines use a new technology called messenger RNA (mRNA).

(Reporting by Julie Steenhuysen; Additional reporting by Manas Mishra, Dania Nadeem and Manojna Maddipatla in Bengalaru and Rebecca Spalding and Michael Erman in New York; Writing by Alexander Smith; Editing by Caroline Humer, Peter Henderson, Edwina Gibbs and Keith Weir)

Racing the virus: Why tweaking the vaccines won’t be simple

By Julie Steenhuysen and Michael Erman

CHICAGO (Reuters) – After developing and rolling out COVID-19 vaccines at record speed, drugmakers are already facing variants of the rapidly-evolving coronavirus that may render them ineffective, a challenge that will require months of research and a massive financial investment, according to disease experts.

Executives from Moderna Inc and Pfizer Inc and partner BioNTech SE are considering new versions of their vaccines to respond to the most concerning variants identified so far. That is just one piece of the work needed to stay ahead of the virus, nearly a dozen experts told Reuters.

A global surveillance network to assess emerging variants must be built. Scientists need to establish what level of antibodies will be required to protect people from COVID-19 and determine when vaccines need to be altered. And regulators must convey what is needed to demonstrate updated vaccines are still safe and effective.

“At this point, there is no evidence that these variants have changed the equation in terms of protection from the vaccine,” said Dr. Michael Osterholm, an infectious disease expert at the University of Minnesota. “But we have to be prepared for that.”

Johnson & Johnson told Reuters the concerning variant first identified in South African has got its attention and will tweak its vaccine accordingly if needed. Pfizer said it could produce a new vaccine relatively quickly, but a top vaccine executive said manufacturing it presents additional challenges.

The urgency of this effort is clear.

Moderna on Monday said lab studies showed antibodies made in response to its vaccine were six times less effective at neutralizing a lab-created version of a South African variant than prior versions of the virus.

A study released on Wednesday ahead of peer review found the South African variant reduced neutralizing antibodies 8.6-fold for the Moderna vaccine and by 6.5-fold for the Pfizer/BioNTech shot, although a separate Pfizer-backed study released on Wednesday suggests its vaccine may be more hardy. Moderna said this week it is starting work on a potential booster shot.

COULD TAKE MONTHS

Just how far protection can drop before a COVID-19 vaccine needs to be altered is not yet known. With influenza, an eightfold drop in vaccine-induced antibody protection means time to update. That does not necessarily apply to this coronavirus.

“The problem is we don’t know what the cut point is for coronavirus,” said Dr. John Mascola, director of the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID), whose scientists helped develop Moderna’s vaccine.

Mascola said both studies testing the Moderna vaccine against the South African variant are roughly in the “same ballpark.” It could be that antibody protection is high enough from the vaccine that it will still be effective, he said.

NIAID scientists are analyzing data from Moderna’s late-stage trial to see what level of neutralizing antibodies is required for protection. They are comparing individuals who were vaccinated but got sick anyway to vaccinated people who remained healthy.

It could take two months to complete this work, Mascola said. They hope to produce a benchmark for the minimum level of vaccine-induced antibodies needed to protect against COVID-19.

A global surveillance network is also needed to identify troubling new variants as they emerge, similar to one used to track fast-mutating flu viruses. That could cost tens to hundreds of millions of dollars in the United States alone.

Richard Webby, a flu surveillance expert from St. Jude Children’s Research Hospital, said the United States could probably build a system to identify variants fairly quickly. Developing the capability to determine whether they evade current vaccines will take more time.

The United States is currently conducting genetic sequencing to look for changes in the virus in just 0.3% of positive coronavirus tests. That pales compared with 10% in the UK, which was first to discover a major mutation in the virus that increases transmission by at least 50%. Experts said countries should sequence at least 5% of positive cases to detect significant changes in the virus.

Companies are waiting for the U.S. Food and Drug Administration to relay what testing will be needed for altered vaccines, said Phil Dormitzer, one of Pfizer’s top viral vaccine scientists. With influenza vaccines, companies can make changes without new trials. “But that’s after doing it for 50 years,” he said.

Peter Marks, who oversees the FDA’s vaccine approval process, has said small trials testing updated vaccines in around 400 participants may be needed at first. Even that could add months to the process.

Norman Baylor, chief executive of Biologics Consulting and a former FDA vaccines official, said the agency will lay out the regulatory road. But public health agencies like the U.S. Centers for Disease Control and Prevention and the World Health Organization would decide when vaccines should be updated, as with flu.

Altering Pfizer’s vaccine would require “a very minor change,” Dormitzer said.

Like Moderna’s, it uses messenger RNA (mRNA) technology, which relies on synthetic genes that can be generated and manufactured in weeks.

He estimates the company could make a prototype version in a week or so, and take another two months to scale up and update their lab tests.

J&J, which is expected to release late-stage trial data on its vaccine within days, has laid the groundwork to address troubling virus changes, Chief Scientific Officer Paul Stoffels told Reuters. Its trial included sites in South Africa, which should give the company insight on that variant.

If a change is necessary, Stoffels said J&J likely would add a second strain into its existing vaccine.

“We are looking at this with a lot of attention,” he said.

(Reporting by Julie Steenhuysen in Chicago and Michael Erman in New York; Editing by Caroline Humer and Bill Berkrot)

J&J COVID-19 vaccine could be available in Europe in April: source

By Francesco Guarascio

BRUSSELS (Reuters) – Johnson & Johnson could deliver the first doses of its COVID-19 vaccine to Europe in April, an EU official told Reuters on Wednesday after a top lawmaker said the U.S. healthcare company was likely to seek EU regulatory approval in February.

Clinical data on the vaccine has been assessed by the European Medicines Agency (EMA) since Dec. 1 under a rolling review to speed up possible approval.

A senior EU official, who is involved in negotiations with vaccine makers and spoke on condition of anonymity, said the J&J shot could be available from April 1 in Europe.

Earlier on Wednesday, an EU lawmaker said J&J could seek EU approval for its one-shot vaccine in February.

“EU Health Commissioner Stella Kyriakides announced during our (EU lawmakers) group meeting this morning that the vaccine manufacturer Johnson & Johnson is likely to submit an application for approval to the EU for their vaccine in February,” said Peter Liese, who speaks on health matters for the EU’s center-right group, the assembly’s largest.

Following Liese’s comments, a spokesman for Kyriakides said: “We cannot give any precise indications regarding an application for conditional marketing authorization, but we of course hope that an application could be submitted in the coming weeks.”

EMA, in a statement, said “a date for submission of a marketing authorization application has not yet been confirmed.”

J&J had no immediate comment on the timeline described by the EU source and the lawmaker, which appeared to be slightly behind expectations for the vaccine in the United States.

J&J Chief Scientific Officer Dr. Paul Stoffels told Reuters the drugmaker expects to have clear data on how effective its vaccine is by the end of this month or early February and was on track for a U.S. rollout in March.

The EU drugs regulator had said in December it expected the J&J to apply in the first quarter of this year.

It took EMA 20 days to approve the vaccine developed by BioNTech SE and Pfizer Inc, and just over a month to authorize the Moderna Inc shot after their applications were submitted in early December. The two vaccines are so far the only ones approved in the EU, while AstraZeneca submitted its application on Tuesday.

“If all goes well, we will already have the fourth corona vaccine available in a few weeks,” Liese added.

The EU has booked 200 million doses of the J&J vaccine and has an option to order another 200 million shots. The J&J vaccine is administered as a single shot, while those from Moderna and Pfizer/BioNTech require two doses three or four weeks apart for full protection.

The EU has invested about 360 million euros ($438 million) to secure the J&J vaccine with a down payment that would need to be complemented with payments by EU governments willing to buy the vaccine after approval.

The U.S. government secured 100 million doses from the company for $1 billion in an August agreement, with an option to buy an additional 200 million doses.

(Reporting by Francesco Guarascio; Additional reporting by Julie Steenhuysen in Chicago; Editing by Jason Neely, Louise Heavens and Bill Berkrot)

Johnson & Johnson ordered to pay $120 million damages in New York baby powder case

By Jonathan Stempel

NEW YORK (Reuters) – Johnson & Johnson has been ordered by a New York state judge to pay $120 million in damages to a Brooklyn woman and her husband, after she blamed her cancer on asbestos exposure from using the company’s baby powder.

Justice Gerald Lebovits of the state supreme court in Manhattan reduced the payout from the $325 million a jury awarded Donna Olson, 67, and Robert Olson, 65, in May 2019 following a 14-week trial.

While upholding the jury’s liability finding, Lebovits wrote on Nov. 11 that the damages were too high, and the Olsons could either accept $120 million or have a new trial on damages.

The judge approved the lowered payout on Wednesday, court records show. It includes $15 million of compensatory damages and $105 million of punitive damages, down from an original $25 million and $300 million, respectively.

Johnson & Johnson said it will appeal the verdict, citing “significant legal and evidentiary errors” at the trial.

“We deeply sympathize with anyone suffering from cancer, which is why the facts are so important,” the company said. “We remain confident that our talc is safe, asbestos free, and does not cause cancer.”

Jerome Block, a lawyer for the Olsons, said they were satisfied with the result and confident it would stand.

He also said Donna Olson’s mesothelioma “is at an advanced stage, and we are hoping for the best.”

Donna Olson had testified that she used Johnson’s Baby Powder or Shower to Shower daily for more than 50 years.

Lebovits wrote that jurors could find that Johnson & Johnson was for many years “knowingly deceitful about” or “willfully blind to” potential health risks of its talc products, in part to maintain market share and profit.

The New Brunswick, New Jersey-based company is appealing to the U.S. Supreme Court a $2.12 billion damages award in Missouri to women who blamed their ovarian cancer on asbestos in its baby powder and other talc products.

Johnson & Johnson has faced intense scrutiny of its raw talc’s safety following a 2018 Reuters investigative report that found it knew for decades about asbestos in its talc.

Internal company records, trial testimony and other evidence show that from at least 1971 to the early 2000s, J&J’s raw talc and finished powders sometimes tested positive for small amounts of asbestos.

(Reporting by Jonathan Stempel in New York; Editing by Chizu Nomiyama and Matthew Lewis)

Johnson & Johnson fails to overturn $2.12 billion baby powder verdict, plans Supreme Court appeal

By Jonathan Stempel

(Reuters) – Missouri’s highest court on Tuesday refused to consider Johnson & Johnson’s appeal of a $2.12 billion damages award to women who blamed their ovarian cancer on asbestos in its baby powder and other talc products.

The Missouri Supreme Court let stand a June 23 decision by a state appeals court, which upheld a jury’s July 2018 finding of liability but reduced J&J’s payout from $4.69 billion after dismissing claims by some of the 22 plaintiffs.

Johnson & Johnson said it plans to appeal to the U.S. Supreme Court.

It said the verdict was the product of a “fundamentally flawed trial, grounded in a faulty presentation of the facts,” and was “at odds with decades of independent scientific evaluations confirming Johnson’s Baby Powder is safe, does not contain asbestos and does not cause cancer.”

Kevin Parker, a lawyer for the plaintiffs, said in a statement: “Johnson & Johnson should accept the findings of the jury and the appellate court and move forward with proper compensation to the victims.”

Johnson & Johnson said in May it would stop selling its Baby Powder talc in the United States and Canada.

The New Brunswick, New Jersey-based company said last month it faces more than 21,800 lawsuits claiming that its talc products cause cancer because of contamination from asbestos, a known carcinogen.

In its June decision, the Missouri Court of Appeals said it was reasonable to infer from the evidence that Johnson & Johnson “disregarded the safety of consumers” in its drive for profit, despite knowing its talc products caused ovarian cancer. It also found “significant reprehensibility” in the company’s conduct.

Johnson & Johnson has faced intense scrutiny of its baby powder’s safety following a 2018 Reuters investigative report that found it knew for decades that asbestos lurked in its talc.

Internal company records, trial testimony and other evidence show that from at least 1971 to the early 2000s, J&J’s raw talc and finished powders sometimes tested positive for small amounts of asbestos.

Johnson & Johnson shares were up 2 cents at $138.71 in late afternoon trading on the New York Stock Exchange.

(Reporting by Jonathan Stempel in New York; Additional reporting by Nate Raymond in Boston; Editing by Leslie Adler and Matthew Lewis)

McKesson says states seek $21 billion from drug distributors in opioid settlement

By Nate Raymond

(Reuters) – McKesson Corp said on Tuesday that it and two other major U.S. drug distributors could be expected pay up to $21 billion under a new proposal by state attorneys general to resolve lawsuits alleging they helped fuel the U.S. opioid crisis.

McKesson and rivals AmerisourceBergen Corp and Cardinal Health Inc last year proposed paying a combined $18 billion to resolve the roughly 3,200 lawsuits, with drugmaker Johnson & Johnson paying another $4 billion.

That proposal, part of a settlement framework negotiated with four state attorneys general, met resistance from lawyers for local governments and several states, leading to further talks. J&J on Oct. 13 said it would now contribute $5 billion.

McKesson in a quarterly report said that under the new $21 billion settlement framework proposed by attorneys general, the San Francisco-based company would pay about $8 billion over 18 years.

The company said the proposal was subject to further negotiations and that it “has not reached a point where settlement is probable.”

AmerisourceBergen declined to comment. Cardinal Health did not immediately respond to a request for comment.

The lawsuits, largely filed by states, counties and cities, seek to hold drug companies responsible for an opioid addiction epidemic that according to U.S. government data resulted in 450,000 overdose deaths from 1997 to 2018.

The lawsuits generally accuse drugmakers of deceptively marketing opioids and distributors of ignoring red flags indicating the prescription painkillers were being diverted for improper uses. They deny wrongdoing.

McKesson on Tuesday said in addition to the $21 billion, the proposed settlement also calls for the distributors to make changes to their programs to guard against the diversion of drugs for illicit purposes.

OxyContin maker Purdue Pharma and generic painkiller manufacturer Mallinckrodt Plc previously filed for bankruptcy protection in connection with their own multibillion-dollar proposals to resolve claims against them in the litigation.

(Reporting by Nate Raymond in Boston and Manas Mishra in Bengaluru; Editing by Peter Graff and Bill Berkrot)

J&J to contribute up to $5 billion to potential U.S. opioid settlement

(Reuters) – Johnson & Johnson on Tuesday said it will contribute up to $1 billion more to a potential settlement of lawsuits alleging it and other companies fueled the U.S. opioid epidemic, bringing the total amount it would pay to $5 billion.

The New Brunswick, New Jersey-based drugmaker said the additional money represented an increase to a proposed $4 billion settlement framework it negotiated with a group of state attorneys general that was announced last year.

That October 2019 proposal also called for the drug distributors McKesson Corp, Cardinal Health and AmerisourceBergen to pay a combined $18 billion, but the framework met resistance from some states and local governments.

Negotiations have been ongoing since then, and the dollar amounts have been shifting. J&J in a statement said the additional $1 billion it would pay reflected continued negotiations and said additional terms are being finalized.

Lawyers for the plaintiffs in the opioid litigation and representatives for several state attorneys general did not immediately respond to requests for comment.

More than 3,000 lawsuits have been filed nationally largely by states, counties and municipalities seeking to hold drug companies responsible for the U.S. opioid addiction epidemic.

The lawsuits generally accuse drugmakers including J&J of deceptively marketing opioids and distributors of ignoring red flags indicating the painkillers were being diverted for improper uses.

The companies including J&J deny wrongdoing. J&J is separately appealing a $465 million judgment the state of Oklahoma won against it in the first case to go to trial in the litigation.

(Reporting by Nate Raymond in Boston; Editing by Chris Reese)

Johnson & Johnson to pay more than $100 million to settle over 1,000 talc lawsuits: Bloomberg

Reuters) – Johnson & Johnson will pay more than $100 million to settle over 1,000 lawsuits that allege the company’s Baby Powder caused cancer, Bloomberg news reported on Monday, citing people with knowledge of the pacts.

J&J faces more than 19,000 lawsuits from consumers and their survivors claiming its talc products caused cancer due to contamination with asbestos, a known carcinogen. The company has maintained that its talc is safe.

The drugmaker declined to comment on the Bloomberg report but reiterated that its talc is safe, does not contain asbestos and does not cause cancer.

“In certain circumstances, we do choose to settle lawsuits, which is done without an admission of liability and in no way changes our position regarding the safety of our products,” the company said in a statement.

In May, J&J said it would stop selling its talc in the United States and Canada after demand had fallen in the wake of what it called “misinformation” about the product’s safety amid a barrage of legal challenges.

J&J has faced scrutiny over the safety of its baby powder following an investigative report by Reuters in 2018 that found the company knew for decades that asbestos lurked in its talc.

(Reporting by Dania Nadeem in Bengaluru; Editing by Saumyadeb Chakrabarty)

Explainer: When will COVID-19 vaccines be generally available in the U.S.?

By Carl O’Donnell and Michael Erman

(Reuters) – U.S. President Donald Trump and the head of the Centers for Disease Control and Prevention (CDC) this week disagreed about when a COVID-19 vaccine would become widely available. Trump has said one could initially be available by the Nov. 3 election, while the CDC director said vaccines were likely to reach the general public around mid-2021, an assessment more in line with most experts.

WHAT DOES IT MEAN FOR A VACCINE TO BE GENERALLY AVAILABLE?

General availability is when every American who wants the vaccine can get it. There are currently no COVID-19 vaccines approved by U.S. regulators, although a handful are in late-stage trials to prove they are safe and effective.

Experts estimate that at least 70% of roughly 330 million Americans would need to be immune through a vaccine or prior infection to achieve what is known as herd immunity, which occurs when enough people are immune to prevent the spread of the virus to those unable to get a vaccine.

HOW LONG BEFORE VACCINE PRODUCTION IS FULLY RAMPED UP?

Most vaccines in development will require two doses per person.

The CDC anticipates that 35 million to 45 million doses of vaccines from the first two companies to receive authorization will be available in the United States by the end of this year. The current front runners are Pfizer Inc and Moderna Inc.

Drugmakers have been more ambitious with their calculations. AstraZeneca Plc has said it could deliver as many as 300 million doses of its experimental vaccine in the United States by as early as October. Pfizer and German partner BioNTech SE have said they expect to have 100 million doses available worldwide by the end of 2020, but did not specify how much of that was earmarked for the United States. Moderna on Friday said it is on track to make around 20 million doses by the end of the year and between 500 million and 1 billion doses a year beginning in 2021.

Obtaining enough doses to inoculate everyone in the United States will likely take until later in 2021. CDC Director Robert Redfield told a congressional hearing on Wednesday that vaccines may not be widely available to everyone in the United States until the second or third quarter of next year.

WHO WOULD GET AN APPROVED VACCINE FIRST?

The CDC decision will likely broadly follow recommendations from the National Academies of Sciences, Engineering and Medicine. The CDC has said the earliest inoculations may go to healthcare workers, people at increased risk for severe COVID-19, and essential workers.

It is unclear when a vaccine will be available for children as major drugmakers have yet to include them in late-stage trials. Pfizer and BioNTech have filed with regulators seeking to start recruiting volunteers as young as 16 for vaccine studies.

WHICH COMPANIES WILL LIKELY ROLL OUT A VACCINE QUICKLY?

Pfizer has said it could have compelling evidence that its vaccine works by the end of October. Moderna says it could have similar evidence in November. The vaccines would first need to be approved or authorized for emergency use by U.S. regulators.

Drugmakers have already started manufacturing supplies of their vaccine candidates to be ready as soon as they get the go ahead. The U.S. Department of Defense and the CDC plan to start distribution of vaccines within 24 hours of regulatory authorization.

Several drugmakers including Pfizer, AstraZeneca, Johnson & Johnson and Novavax Inc have all said they expect to produce at least 1 billion doses of their vaccines next year if they get regulatory authorization.

Sanofi SA and GlaxoSmithKline Plc are also working on developing a vaccine they say could be authorized next year.

(Reporting by Carl O’Donnell and Michael Erman in New York; additional reporting by Caroline Humer; editing by Peter Henderson and Bill Berkrot)