Pfizer says earliest COVID-19 vaccine application to U.S. regulators would be after election

By Manas Mishra and Michael Erman

(Reuters) – Pfizer Inc said on Friday it may file for U.S. authorization of the COVID-19 vaccine it is developing with German partner BioNTech in late November, making it unlikely a vaccine will be available before the U.S. election as President Donald Trump has promised.

Pfizer said that it may say if the vaccine is effective as soon as this month based on its 40,000 person clinical trial but that it also needs safety data that will not be available until November at the earliest.

The Pfizer news, published in a letter from its chief executive on its website, lifted the U.S. stock market and the company’s shares. Shares were up slightly in rival vaccine maker Moderna Inc, which is close to Pfizer in its vaccine development.

“So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November,” Pfizer Chief Executive Albert Bourla said.

Trump has said repeatedly that there would be a vaccine available before the election, but health officials and companies had only said that data might be available this month. The possibility of further delays was raised after trials for two rival vaccines were put on hold in the United States this fall.

The president’s rush to a vaccine has also raised concerns that the U.S. Food and Drug Administration, acting in haste, might not conduct an adequate review of the vaccine.

U.S. health officials have sought to assuage those concerns out of fear that not enough Americans would take a vaccine early on. Earlier this month, the FDA formalized a requirement that the vaccine makers collect two months of safety data on one-half of trial participants.

Pfizer’s comments on its time line raise the possibility of U.S. authorization of a coronavirus vaccine this year, a key step in controlling the COVID-19 pandemic, which has killed more than a million people and ravaged the global economy.

Moderna could also apply for an emergency use authorization (EUA) this year. It has said that it may have interim data on its 30,000 person trial as soon as November.

Both companies are also applying for approval in Europe, where they are racing against AstraZeneca PLC. AstraZeneca’s U.S. trial has been on hold since September.

After the FDA announced the two-month requirement on Oct. 6, which was approved by the White House but undercut the likelihood of a vaccine before voters go to polls on Nov. 3., Trump called the move a ‘political hit job.’

In addition to safety and efficacy, the FDA will also examine Pfizer’s manufacturing operations for the vaccine.

Bourla said the filing depended on several other factors, including initial data on effectiveness that may or may not be available by late October.

He said the company plans to share efficacy data with the public as soon as practical. (https://bit.ly/31bWdpP)

A BioNTech spokeswoman confirmed the time frame for the possible EUA application to the FDA.

Pfizer’s shares rose 2.1% in premarket trading, while BioNTech’s U.S-listed shares were up 4% before the opening bell. Moderna was unchanged and U.S. futures were higher.

(Reporting by Manas Mishra, Manojna Maddipatla in Bengaluru and Michael Erman in New Jersey, Patricia Weiss in Frankfurt; writing by Caroline Humer in New York; Editing by Patrick Graham, Saumyadeb Chakrabarty and Steve Orlofsky)

Exclusive: New global lab network will compare COVID-19 vaccines head-to-head

By Kate Kelland

LONDON (Reuters) – A major non-profit health emergencies group has set up a global laboratory network to assess data from potential COVID-19 vaccines, allowing scientists and drugmakers to compare them and speed up selection of the most effective shots.

Speaking to Reuters ahead of announcing the labs involved, Melanie Saville, director of vaccine R&D at the Coalition for Epidemic Preparedness Innovations (CEPI), said the idea was to “compare apples with apples” as drugmakers race to develop an effective shot to help control the COVID-19 pandemic.

The centralized network is the first of its kind to be set up in response to a pandemic.

In a network spanning Europe, Asia and North America, the labs will centralize analysis of samples from trials of COVID-19 candidates “as though vaccines are all being tested under one roof”, Saville said, aiming to minimize the risk of variation in results.

“When you start off (with developing potential new vaccines) especially with a new disease, everyone develops their own assays, they all use different protocols and different reagents – so while you get a readout, the ability to compare between different candidates is very difficult,” she told Reuters.

“By taking the centralized lab approach … it will give us a chance to really make sure we are comparing apples with apples.”

The CEPI network will initially involve six labs, one each in Canada, Britain, Italy, the Netherlands, Bangladesh and India, Saville said.

Hundreds of potential COVID-19 vaccines are in various stages of development around the world, with shots developed in Russia and China already being deployed before full efficacy trials have been done, and front-runners from Pfizer, Moderna and AstraZeneca likely to have final-stage trial results before year-end.

Typically, the immunogenicity of potential vaccines is assessed in individual lab analyses, which aim to see whether biomarkers of immune response – such as antibodies and T-cell responses – are produced after clinical trial volunteers receive a dose, or doses, of the vaccine candidate.

But with more than 320 COVID-19 vaccine candidates in the works, Saville said, the many differences in data collection and evaluation methods are an issue.

As well as potential variations in markers of immunity, there are differences in how and where samples are collected, transported and stored – all of which can impact the quality and usefulness of the data produced, and make comparisons tricky.

And with a range of different vaccine technologies being explored – from viral vector vaccines to ones based on messenger RNA – standard evaluation of their true potential “becomes very complex”, she said.

“With hundreds of COVID-19 vaccines in development … it’s essential that we have a system that can reliably evaluate and compare the immune response of candidates currently undergoing testing,” she said.

By centralizing the analysis in a lab network, much of what Saville called the “inter-laboratory variability” can be removed, allowing for head-to-head comparisons.

CEPI says all developers of potential COVID-19 vaccines can use the centralized lab network for free to assess their candidates against a common protocol. For now, the network will assess samples from early-stage vaccine candidate testing and first and second stage human trials, but CEPI said it hoped to expand its capacity to late stage (Phase III) trial data in the coming months.

Results produced by the network will be sent back to the developer, with neither CEPI nor the network owning the data.

CEPI itself is co-funding nine of the potential COVID-19 vaccines in development, including candidates from Moderna, AstraZeneca, Novavax and CureVac.

(Reporting by Kate Kelland, editing by Mark Potter)

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)

Philippines presidential spokesman links pardon of U.S. Marine to vaccine access

MANILA (Reuters) – Philippine President Rodrigo Duterte’s decision to pardon a United States Marine convicted of killing a transgender woman nearly six years ago may have stemmed from his desire to get access to coronavirus vaccines being developed by U.S. firms, his spokesman said on Thursday.

“His decision didn’t surprise me. Why? Because I know he is upholding the higher national interest”, Harry Roque said in a regular news briefing when asked to give his “personal take” on the president’s move.

Duterte on Monday pardoned Lance Corporal Joseph Scott Pemberton who was serving a six- to 10-year sentence for killing Jennifer Laude near a former U.S. navy base in 2014, sparking condemnation from activists who described the move as a “mockery of justice”.

Roque, who served as lawyer in the prosecution of Pemberton, had likened Laude’s killing to the “death of Philippine sovereignty”.

“I think this pardon, although this is my personal opinion, was to ensure Filipinos would benefit from a vaccine against COVID-19 should the Americans develop one,” Roque said. “I don’t see any problem with that”.

The Philippines, among a number of developing countries with large populations keen to secure a supply a COVID-19 vaccine, met with representatives of U.S. drugmaker Pfizer Inc last week.

U.S. public health officials and Pfizer said a COVID-19 vaccine could be ready for distribution in the United States as soon as next month

Duterte has pledged that the country, which has the most coronavirus infections and second largest number of COVID-19 deaths in Southeast Asia, would be “back to normal” by December, pinning his hopes on access to affordable vaccines from countries like China and Russia.

The Southeast Asian nation, which has more than 248,000 confirmed COVID-19 cases, plans to buy 40 million doses worth $400 million for 20 million people, about a fifth of its 107 million population.

(Reporting by Karen Lema; editing by Philippa Fletcher)

U.S., European COVID vaccine developers pledge to uphold testing rigor

By Ludwig Burger, Patricia Weiss and Caroline Copley

FRANKFURT (Reuters) – Nine leading U.S. and European vaccine developers pledged on Tuesday to uphold the scientific standards their experimental immunizations will be held against in the global race to contain the coronavirus pandemic.

The companies, including Pfizer, GlaxoSmithKline and AstraZeneca, issued what they called a “historic pledge” after a rise in concern that safety and efficacy standards might slip in the rush to find a vaccine.

The companies said in a statement they would “uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines”.

The other signatories were Johnson & Johnson, Merck & Co., Moderna, Novavax, Sanofi and BioNTech.

The promise to play by established rules underlines a highly politicized debate over what action is needed to rein in COVID-19 quickly and to jump start global business and trade.

The head of the U.S. Food and Drug Administration (FDA) said last month COVID-19 vaccines may not necessarily need to complete Phase Three clinical trials – large-scale testing intended to demonstrate safety and efficacy – as long as officials are convinced the benefits outweigh the risks.

This prompted a call for caution from the World Health Organization (WHO).

Developers globally have yet to produce large-scale trial data showing actual infections in participants, yet Russia granted approval to a COVID-19 vaccine last month, prompting some Western experts to criticize a lack of testing.

The head of China’s Sinovac Biotech has said most of its employees and their families have already taken an experimental vaccine developed by the Chinese firm under the country’s emergency-use program.

Chinese companies or institutions, which are involved in several leading vaccine projects, did not sign the statement.

PROMISE ON SAFETY AND EFFICACY

“We want it to be known that also in the current situation we are not willing to compromise safety and efficacy,” said co-signatory Ugur Sahin, chief executive of Pfizer’s German partner BioNTech.

“Apart from the pressure and the hope for a vaccine to be available as fast as possible, there is also a lot of uncertainty among people that some development steps may be omitted here.”

BioNTech and Pfizer could unveil pivotal trial data as early as October, potentially placing them at the center of bitter U.S. politics before the Nov. 3 presidential election.

President Donald Trump has said it is possible the United States will have a vaccine before the election. His Democratic rival, Kamala Harris, has said she would not take his word alone on any potential coronavirus vaccine.

The nine companies said they would follow established guidance from expert regulatory authorities such as the FDA.

Among other hurdles, approval must be based on large, diverse clinical trials with comparative groups that do not receive the vaccine in question. Participants and those working on the trial must not know which group they belong to, according to the pledge.

BioNTech’s Sahin said there must be statistical certainty of 95%, in some cases higher, and that a positive reading on efficacy does not come just from random variations but reflects the underlying workings of the compound.

The development race has intensified safety concerns about an inoculation, polls have shown.

Western regulators have said they would not cut corners but rather prioritize the review workload and allow for development steps in parallel that would normally be handled consecutively.

Sahin declined to comment on regulators specifically or on what events prompted the joint statement.

The chief executive of German vaccine developer Leukocare, which did not sign the pledge, was more forthright.

“What Russia did – and maybe also there are tendencies in the U.S. to push the approval of a vaccine which has not been sufficiently developed in clinic – bears a huge risk,” said CEO Michael Scholl.

“My biggest fear is that we will approve vaccines that are not safe and that will have a negative impact on the concept of vaccinations in general.”

Leukocare is working with Italy’s ReiThera and Belgium’s Univercells to produce a COVID-19 vaccine currently in phase I testing.

(Reporting by Ludwig Burger, Patricia Weiss in Frankfurt and Caroline Copley in Berlin; Editing by Susan Fenton and Timothy Heritage)

Two Major Cyber Attacks disrupt service on major sites

An attendee looks at a monitor at the Parsons booth during the 2016 Black Hat cyber-security conference in Las Vegas, Nevada, U.S

By Jim Finkle and Dustin Volz

(Reuters) – Cyber attacks targeting the internet infrastructure provider Dyn disrupted service on major sites such as Twitter and Spotify on Friday, mainly affecting users on the U.S. East Coast.

It was not immediately clear who was responsible and Gillian Christensen of the U.S. Department of Homeland Security said the agency was “investigating all potential causes.”

Dyn said it had resolved one attack, which disrupted operations for about two hours, but disclosed a second attack a few hours later that was causing further disruptions.

In addition to the social network Twitter and music-streamer Spotify, the discussion site Reddit, hospitality booking service Airbnb and The Verge news site were among the companies whose services were reported to be down.

Amazon.com Inc’s web services division, one of the world’s biggest cloud computing companies, also disclosed an outage that lasted several hours on Friday morning. Amazon could not immediately be reached for comment.

The attacks were the latest in an increasingly menacing string of distributed denial of service, or DDoS, attacks disrupting internet sites by overwhelming servers with web traffic.

The U.S. Department of Homeland Security warned on Oct. 14 that hackers were using a powerful new approach to launch these campaigns – infecting routers, printers, smart TVs and other connected devices with malware that turns them into “bot” armies that can launch DDoS attacks.

“We have begun monitoring and mitigating a DDoS attack against our Dyn Managed DNS infrastructure,” the company said on its website. “Our engineers are continuing to work on mitigating this issue.”

Doug Madory, director of internet analysis at Dyn, told Reuters he was not sure if the outages at Dyn and Amazon were connected.

“We provide service to Amazon but theirs is a complex network so it is hard to be definitive about causality at the moment,” he said.

Dyn is a Manchester, New Hampshire-based provider of services for managing domain name servers (DNS), which act as switchboards connecting internet traffic. Requests to access sites are transmitted through DNS servers that direct them to computers that host websites.

Dyn’s customers include some of the world’s biggest corporations and Internet firms, such as Pfizer, Visa, Netflix and Twitter, SoundCloud and BT.

(Reporting By Jim Finkle in Boston and Dustin Volz in Washington; Additional reporting by Eric Auchard in Frankurt and Malathi Nayak in New York, Jeff Mason in Washington; Editing by Bill Trott)