Tag Archives: AstraZeneca Plc

U.S. puts J&J in charge of plant that botched COVID vaccine, removes AstraZeneca

By Shubham Kalia

(Reuters) – The United States has put Johnson and Johnson in charge of a plant that ruined 15 million doses of its COVID-19 vaccine and has stopped British drugmaker AstraZeneca Plc from using the facility, a senior health official said on Saturday.

J&J said it was “assuming full responsibility” of the Emergent BioSolutions facility in Baltimore, reiterating that it will deliver 100 million doses to the government by the end of May.

In a separate statement late Sunday, Emergent said it expects to align with the U.S. government and AstraZeneca to ramp down manufacturing for AstraZeneca’s COVID-19 vaccine at its Baltimore plant.

The Department of Health and Human Services has also increased Emergent’s order by $23 million for expansion of production specific to J&J’s vaccine doses, Emergent added.

“The $23 million will be used for the purchase of biologics manufacturing equipment specific to Johnson & Johnson’s COVID-19 vaccine for the potential expansion of manufacturing of that bulk drug substance into a third suite of Emergent’s Baltimore Bayview facility,” the company said.

The Department of Health and Human Services facilitated the move, the health official said in an email, asking not to be named due to the sensitivity of the matter.

AstraZeneca, whose vaccine has not been approved in the United States, said it will work with President Joe Biden’s administration to find an alternative site to produce its vaccine.

White House officials did not immediately respond to a request for comment.

The development, first reported by the New York Times, further hampers AstraZeneca’s efforts in the United States. The government has criticized the drugmaker for using outdated data in the results of its vaccine trial. It later revised its study.

Workers at the Emergent BioSolutions plant several weeks ago conflated ingredients for the J&J and AstraZeneca vaccines, the Times said earlier in the week. J&J said at the time the ruined batch had not advanced to the fill-and-finish stage.

The government’s move to have the facility make only the J&J single-dose vaccine is meant to avoid future mix-ups, the Times said, citing two senior federal health officials.

The top U.S. infectious disease doctor told Reuters on Thursday the country may not need AstraZeneca’s vaccine even if it wins approval.

The United States has loan deals to send Mexico and Canada roughly 4 million doses of the AstraZeneca vaccine, made at its U.S. facility.

(Reporting by Shubham Kalia, Vishal Vivek and Aakriti Bhalla in Bengaluru; Additional reporting by Steve Holland in Washington; Editing by William Mallard and Stephen Coates)

Exclusive: Oxford study indicates AstraZeneca effective against Brazil variant, source says

By Rodrigo Viga Gaier

RIO DE JANEIRO (Reuters) – Preliminary data from a study conducted at the University of Oxford indicates that the COVID-19 vaccine developed by AstraZeneca PLC is effective against the P1, or Brazilian, variant, a source with knowledge of the study told Reuters on Friday.

The data indicates that the vaccine will not need to be modified in order to protect against the variant, which is believed to have originated in the Amazonian city of Manaus, said the source, who requested anonymity as the results have not yet been made public.

The source did not provide the exact efficacy of the vaccine against the variant. They said the full results of the study should be released soon, possibly in March.

Early results indicated the AstraZeneca vaccine was less effective against the South African variant, which is similar to P1. South Africa subsequently paused the use of the vaccine in the country.

The information comes as a small-sample study suggested the COVID-19 vaccine developed by China’s Sinovac may not work effectively against the Brazilian variant.

Responding to a request for comment, Fiocruz, which sent the samples that formed the basis of the study, told Reuters it did not have any information on the study, as it was being led by AstraZeneca and the University of Oxford.

Representatives for AstraZeneca and the University of Oxford did not immediately respond to requests for comment.

Brazil is currently confronting a brutal and long-lasting second wave of the coronavirus, hitting a daily record of 1,910 deaths on Wednesday.

The P1 variant is among the factors that epidemiologists believe is contributing to a rise in cases and deaths, and there has been concern in the scientific community about the variant’s resistance to vaccines.

(Reporting by Rodrigo Viga Gaier; Writing by Gram Slattery; Editing by Hugh Lawson)

Not perfect, but saves lives, AstraZeneca says as Africa backs COVID-19 shot

By Pushkala Aripaka and Ludwig Burger

(Reuters) – AstraZeneca’s COVID-19 vaccine is not perfect, but will have a big impact on the pandemic, its chief executive predicted on Thursday, as the drugmaker pledged to double output by April and the African Union gave its backing for the shot.

The two-dose inoculation, developed with Oxford University, has been hailed as a “vaccine for the world” because it is cheaper and easier to distribute than some rivals.

But its rapid approval in Europe and elsewhere has been clouded by doubts over its most effective dosage and interval between doses.

Data at the weekend also showed it was less effective against a fast-spreading variant of the virus in South Africa, prompting the country to pause rollout of the shot, and the company has also been embroiled in a row with the European Union over supply delays.

“Is it perfect? No, it’s not perfect, but it’s great. Who else is making 100 million doses in February?” CEO Pascal Soriot said on a conference call about the vaccine.

“We’re going to save thousands of lives and that’s why we come to work everyday.”

The company said it aimed to produce more than 200 million doses per month by April, double this month’s level as the world tries to tame a pandemic that has killed 2.35 million.

Head of operations Pam Cheng said on the call that the group was working to further expand global capacity and productivity.

AstraZeneca has set a target to produce 3 billion doses this year, with India’s Serum Institute making much of that aimed at poorer nations.

On Wednesday, the company enlisted Germany’s IDT Biologika as a contract manufacturer, but the bulk of IDT’s contribution will only come onstream late next year.

AstraZeneca said it expected much-anticipated data from the U.S. trial of the vaccine before the end of March, and that it was confident the shot offered relatively good protection against severe disease and death for the South African variant. Its disappointing results were against milder cases.

However, after rising to become Britain’s most valuable company last summer, the company has now slipped to sixth, in a move some analysts attribute to doubts over the vaccine.

“In a year or two we will look back and everybody will realize we made a big impact,” Soriot said.

POSTER CHILD

AstraZeneca’s shares were up 0.95% in afternoon trade, paring some earlier gains, after the company forecast a pick up in earnings growth this year on strong demand for its cancer and other new therapies.

It has pledged not to make any money from its COVID-19 vaccine during the pandemic.

It has been a tumultuous week for the drugmaker after South Africa put on hold giving the shot to its citizens, choosing one developed by its U.S. rival Johnson & Johnson instead.

That came after the trial data raised concerns about the AstraZeneca vaccine’s effectiveness on mild symptoms from the more infectious 501Y.V2 variant of the virus dominant in South Africa, which has spread to 41 nations around the world.

Despite that blow, the World Health Organization endorsed the British vaccine on Wednesday and the African Union said it would target its use in countries that have not reported cases of the variant.

Kenya and Morocco are also planning to administer it.

AstraZeneca said it expected 2021 revenues to rise by a low teens percentage and core earnings of $4.75 to $5.00 per share, as it beat expectations for fourth-quarter sales.

The earnings guidance equates to 18-24% growth, after 15% in 2020, but was a little lower than the $5.10 per share analysts were expecting, as the company flagged more spending this year.

The COVID-19 vaccine is not included in the guidance and the company said its sales would be reported separately from the first quarter of 2021.

While public interest is focused on the vaccine, AstraZeneca’s core business of diabetes, heart, kidney, and cancer medicines has been steadily growing, helping the company to turn around years of decline.

“The company is arguably the poster child for big pharma turnarounds,” said Third Bridge senior analyst Sebastian Skeet.

(Reporting by Pushkala Aripaka and Ludwige Burger. Editing by Josephine Mason and Mark Potter)

Explainer-When and how will COVID-19 vaccines become available?

By Julie Steenhuysen and Carl O’Donnell

NEW YORK (Reuters) – Pfizer Inc with partner BioNTech SE and Moderna Inc have released trial data showing their COVID-19 vaccines to be about 95% effective at preventing the illness, while AstraZeneca Plc this week said its vaccine could be up to 90% effective.

If regulators approve any of the vaccines in coming weeks, the companies have said distribution could begin almost immediately with governments around the world to decide who gets them and in what order. The following is an outline of the process:

WHEN WILL COMPANIES ROLL OUT A VACCINE?

Pfizer, Moderna and AstraZeneca have already started manufacturing their vaccines. This year, Pfizer said it will have enough to inoculate 25 million people, Moderna will have enough for 10 million people and AstraZeneca will have enough for more than 100 million people.

The U.S. Department of Defense and the Centers for Disease Control and Prevention (CDC) will manage distribution in the United States, likely starting in mid-December with an initial release of 6.4 million doses nationwide.

UK health authorities plan to roll out an approved vaccine as quickly as possible, also expected in December.

In the European Union, it is up to each country in the 27-member bloc to start distributing vaccines to their populations.

WHO WOULD GET AN APPROVED VACCINE AND WHEN IN THE UNITED STATES?

Upon authorization from the U.S. Food and Drug Administration, the CDC has said first in line for vaccinations would be about 21 million healthcare workers and 3 million residents in long-term care facilities.

Essential workers, a group of 87 million people who do crucial work in jobs that cannot be done from home, are the likely next group. This includes firefighters, police, school employees, transportation workers, food and agriculture workers and food service employees.

Around 100 million adults with high-risk medical conditions and 53 million adults over the age of 65, also considered at higher risk of severe disease, are the next priority.

U.S. public health officials said vaccines will be generally available to most Americans in pharmacies, clinics and doctors offices starting in April so that anyone who wants a shot can have one by the end of June.

It is unclear when a vaccine will be available for children. Pfizer and BioNTech have started testing their vaccine in volunteers as young as 12.

WHEN WILL A VACCINE BE AVAILABLE IN OTHER COUNTRIES?

The European Union, the United Kingdom, Japan, Canada and Australia are all running rapid vaccine regulatory processes.

Many of AstraZeneca’s doses this year are expected to go to the United Kingdom, where health officials have said that if approved they could begin vaccinating people in December. At the top of their list is people living and working in care homes.

In Europe, the E.U. drugs regulator has said it could rule on the safety of a COVID-19 vaccine in December.

Most countries have said the first vaccines will go to the elderly and vulnerable and frontline workers like doctors.

Countries say they are buying vaccines via the European Commission’s joint procurement scheme, which has deals for six different vaccines and nearly 2 billion doses.

Delivery timelines vary and most countries are still drawing up plans for distributing and administering shots.

Italy expects to receive the first deliveries of the Pfizer-BioNTech shot and AstraZeneca’s shot early next year. Spain plans to give vaccines in January.

In Bulgaria, the country’s chief health inspector expects the first shipments in March-April. Hungary’s foreign minister said doses will land in the spring at the earliest.

Germany, home to BioNTech, expects to roll out shots in early 2021 with mass vaccination centers in exhibition halls, airport terminals and concert venues. It will also use mobile teams for care homes. Front-line healthcare workers and people at risk for serious COVID-19 are expected to get inoculated first.

WHEN WILL DEVELOPING COUNTRIES HAVE ACCESS TO VACCINES?

COVAX, a program led by the World Health Organization and the GAVI vaccine group to pool funds from wealthier countries and nonprofits to buy and distribute vaccines to dozens of poorer countries, has raised $2 billion.

Its first goal is to vaccinate 3% of the people in these countries with a final goal of reaching 20%. It has signed a provisional agreement to buy AstraZeneca’s vaccine, which does not require storage in specialized ultra cold equipment like the Pfizer vaccine.

It is expected but not certain that less wealthy countries in Africa and South East Asia, such as India, will receive vaccines at low or no cost under this program in 2021. Other countries such as those in Latin America may buy vaccines through COVAX. Several are also striking supply deals with drugmakers.

HOW MUCH WILL IT COST?

Vaccine makers and governments have negotiated varying prices, not all of which are public. Governments have paid from a few dollars per AstraZeneca shot to up to $50 for the two-dose Pfizer regimen. Many countries have said they will cover the cost of inoculating their residents.

(Reporting by Carl O’Donnell and Julie Steenhuysen; Additional reporting by Michael Erman in New York, Caroline Copley in Berlin, Francesco Gaurascio in Brussels, Josephine Mason in London, Krisztina Than in Budapest and Tsvetelia Tsolova in Sofia; Editing by Caroline Humer and Bill Berkrot)

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. inks $1.5 billion deal with Moderna for 100 million doses of COVID-19 vaccine

By Jeff Mason and Carl O’Donnell

(Reuters) – The United States has entered an agreement with drugmaker Moderna Inc to acquire 100 million doses of its potential COVID-19 vaccine for around $1.5 billion, the company and White House said on Tuesday.

The United States in recent weeks has made deals to acquire hundreds of millions of doses of potential COVID-19 vaccines from several companies as part of its Operation Warp Speed program, which aims to deliver a vaccine in the country by the end of the year.

Moderna’s price per dose comes to around $30.50 per person for a two dose regimen.

With the exception of its deal with AstraZeneca, which offered a lower price per drug in exchange for upfront research and development costs, all the deals price COVID-19 vaccines between $20 to $42 for a two dose course of treatment.

Moderna’s vaccine candidate, mRNA-1273, is one of the few that have already advanced to the final stage of testing and is on track to be completed in September, the company said this month.

Moderna’s deal with the U.S. only pays out in full if the drugmaker hits certain unspecific timing benchmarks for vaccine delivery.

The United States has advanced purchase agreements with Johnson & Johnson, AstraZeneca Plc, Pfizer Inc and BioNTech SE, and Sanofi SA and GlaxoSmithKline Plc for their respective vaccine candidates.

The agreements would lock in more than 500 million doses of COVID-19 vaccine for the U.S., assuming that the companies involved receive regulatory approval. Some deals also give the United States an option to purchase additional doses.

The U.S. government previously gave Moderna around $1 billion to fund its research efforts, bringing total U.S. funding to around $2.5 billion.

Other countries, including Japan, the United Kingdom and Canada, have forged similar deals with drugmakers.

(Reporting by Jeff Mason and Carl O’Donnell; Editing by Peter Henderson, Chris Reese and Tom Brown)