Moderna begins study of COVID-19 vaccine in kids

(Reuters) – Moderna Inc has begun dosing patients in a mid-to-late stage study of its COVID-19 vaccine, mRNA-1273, in children aged six months to less than 12 years, the company said on Tuesday.

The study will assess the safety and effectiveness of two doses of mRNA-1273 given 28 days apart and intends to enroll about 6,750 children in the United States and Canada.

The vaccine has already been authorized for emergency use in Americans who are aged 18 and older.

In a separate study which began in December, Moderna is also testing mRNA-1273 in adolescents between 12 and 18 years old.

The latest study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Shailesh Kuber)

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)

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)

4.2 million COVID-19 cases in November

WASHINGTON (Reuters) – The United States entered the final month of the year hoping that promising vaccine candidates will soon be approved to halt the rapidly spreading novel coronavirus after 4.2 million new cases were reported in November.

The new COVID-19 cases were more than double the previous monthly record set in October, as large numbers of Americans still refuse to refuse to wear masks and continue to gather in holiday crowds, against the recommendation of experts.

A Food and Drug Administration panel of outside advisers will meet on Dec. 10 to discuss whether to recommend the FDA authorize emergency use of a vaccine developed by Pfizer Inc.

A second candidate from Moderna Inc could follow a week later, officials have said, raising hopes that Americans could start receiving inoculations before the end the year, although widespread vaccinations could take months.

Other global pharmaceuticals including AstraZeneca PLC and Johnson & Johnson also have vaccines in the works, leading a member of the Trump administration’s “Operation Warp Speed” program to predict the country could be vaccinated by June.

“One hundred percent of the Americans that want the vaccine will have the vaccine by (June). We will have over 300 million doses available to the American public well before then,” Paul Ostrowski, the vaccine program’s director of supply, production and distribution, told MSNBC television on Monday.

In the meantime, leading health officials are pleading with Americans to follow their recommendations and help arrest a pandemic that killed more than 36,000 people in November, pushing hospitalizations to a record high of nearly 93,000 on Sunday, according to a Reuters tally.

The widespread impact of the pandemic has led Merriam-Webster to choose “pandemic” as the Word of the Year after it racked up the most online dictionary lookups of any word.

“Sometimes a single word defines an era, and it’s fitting that in this exceptional – and exceptionally difficult – year, a single word came immediately to the fore,” the dictionary publisher said.

In the absence of a federal blueprint to curb the spread of the virus, states are issuing new or revamped restrictions on businesses and social life.

California’s governor said he may renew a stay-at-home order in the coming days, warning that ICU admissions are on track to exceed statewide capacity by mid-December unless public health policies and social behavior change.

“The red flags are flying,” Governor Gavin Newsom told reporters in an online briefing. “If these trends continue, we’re going to have to take much more dramatic, arguably drastic, action.”

(Reporting by Reuters staff; Writing by Daniel Trotta; Editing by Bernadette Baum)

Moderna to seek U.S. and EU authorization for its vaccine on Monday

By Julie Steenhuysen and Michael Erman

(Reuters) – Moderna Inc will apply for U.S. and European emergency authorization for its COVID-19 vaccine on Monday after full results from a late-stage study showed it was 94.1% effective with no serious safety concerns, the company said.

Moderna also reported that its vaccine’s efficacy rate was consistent across age, race, ethnicity and gender demographics as well as having a 100% success rate in preventing severe cases of a disease that has killed nearly 1.5 million people.

The filing sets Moderna’s product up to be the second vaccine likely to receive U.S. emergency use authorization this year following a shot developed by Pfizer and BioNTech which had a 95% efficacy rate.

“We believe that we have a vaccine that is very highly efficacious. We now have the data to prove it,” Moderna Chief Medical Officer Tal Zaks said. “We expect to be playing a major part in turning around this pandemic.”

Of the 196 people who contracted COVID-19 out of over 30,000 volunteers, 185 had received a placebo and 11 got the vaccine. Moderna reported 30 severe cases, all in the placebo group, which means the vaccine was 100% effective against severe cases.

Moderna shares opened 13% higher at a record $144 following the results and then went on to hit a peak of $150.14, or a gain of 668% so far this year.

“As the numbers of cases reported grows, confidence grows that this amazing protection will be maintained in a product that can be rolled out to protect the public,” said Alexander Edwards, associate professor in biomedical technology at Britain’s University of Reading.

In addition to filing its U.S. application, Moderna said it would seek conditional approval from the European Medicines Agency, which is already reviewing its data, and would continue to talk with other regulators doing similar rolling reviews.

“Although we await the full details of these results in published form, we can now assume that this vaccine will be approved for use in December,” said Gillies O’Bryan-Tear, chair of policy and communications at Britain’s Faculty of Pharmaceutical Medicine.

He expected Britain’s Medicines and Healthcare products Regulatory Agency to approve the vaccine within two weeks.

Pfizer has already applied for emergency use authorization in the United States and Europe, putting it about a week ahead of Moderna.

‘JUST OVERWHELMING’

Moderna said it was on track to have about 20 million doses of its vaccine ready to ship in the United States by the end of 2020, enough to inoculate 10 million people.

Switzerland’s Lonza, which has a contract with Moderna to supply ingredients for the vaccine, rose 4.4%.

The vaccines developed by both Moderna and Pfizer/BioNTech use a new technology called synthetic messenger RNA (mRNA) whereas others, such as Britain’s AstraZeneca, are using more traditional methods.

AstraZeneca has announced an average efficacy rate of 70% for its shot and as much as 90% for a subgroup of trial participants who got a half dose, followed by a full dose. But some scientists have expressed doubts about the robustness of the 90% efficacy figure for the smaller group.

Moderna’s latest efficacy result is slightly lower than an interim analysis released on Nov. 16 of 94.5% effectiveness, a difference that Zaks said was not statistically significant.

“At this level of effectiveness, when you just do the math of what it means for the pandemic that’s raging around us, it’s just overwhelming,” said Zaks, who said he cried when he saw the final results over the weekend.

Both the Moderna and Pfizer vaccines proved more effective than anticipated and were far superior to the 50% benchmark set by the U.S. Food and Drug Administration (FDA).

The past few weeks of positive vaccine results have ignited hopes for an end to a pandemic that has battered economies and come as new infections and COVID-19 hospitalizations are at record levels across the United States.

Independent advisers to the FDA are scheduled to meet on Dec. 10 to review Pfizer’s data and make a recommendation to the U.S. regulator. They will review Moderna’s data a week later.

Soon after getting the green light, Moderna expects its vaccine to be shipped to distribution points across the United States by the government’s Operation Warp Speed program and drug distributor McKesson Corp.

The distribution is expected to be easier than Pfizer’s because while it needs to be stored in a freezer, it does not require the ultra-cold temperature needed by Pfizer’s vaccine.

CONSISTENT ACROSS AGE AND ETHNICITY

Moderna said the 196 COVID-19 cases in its trial included 33 adults over 65 years old and 42 volunteers from racially diverse groups, including 29 Latinos, 6 Blacks, 4 Asian Americans and 3 multiracial participants. There was one death related to COVID-19 in the placebo group during the trial.

“This is as black and white as an effect on a population will be. Your chances of actually being sick if you’ve been vaccinated are decreased 20-fold,” said Moderna’s Zaks.

Azra Ghani, chair in infectious disease epidemiology at Imperial College London, said Monday’s details confirmed the vaccine was highly effective, including against severe cases.

“Whilst this does not exclude some risk of severe disease after vaccination given the relatively small number of severe cases, these results suggest very high efficacy,” she said.

Moderna reported no new side effects since its interim analysis, which showed the most common side effects were fatigue, injection site redness and pain, headache and body aches, which rose after the second dose and were short-lived.

Zaks said the vaccine caused significant flu-like symptoms in some participants which, “goes hand-in-hand with having such a potent vaccine.” But it has not caused any significant safety concerns so far, he said.

Moderna plans to start a new trial to test the vaccine in adolescents before the end of the year, followed by another in even younger volunteers early in 2021. It hopes to have the vaccine available for adolescents by September, Zaks said.

Other vaccine makers have said they are studying their vaccines in young people as well.

(Reporting by Julie Steenhuysen and Michael Erman; Additional reporting by Ankur Banerjee and Manas Mishra in Bengaluru and Kate Kelland in London; Editing by Bill Berkrot, Edwina Gibbs and David Clarke)

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)

Moderna says UK deal will supply COVID-19 vaccine from March

(Reuters) – Moderna Inc confirmed on Tuesday it had agreed to supply its COVID-19 vaccine candidate, mRNA-1273, to the United Kingdom starting from the beginning of March, as long as it succeeds in gaining local regulatory approval.

The company’s statement did not disclose other terms of the agreement, including the number of doses it agreed to supply.

UK Health Minister Matt Hancock told a news conference on Monday that the deal would see the U.S. startup, one of two vaccine makers who have so far published positive data on final-stage trials, supply five million doses from next spring.

Moderna on Monday said mRNA-1273 was 94.5% effective in preventing COVID-19 based on interim data from its late-stage clinical trial.

Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) in October started a real-time review of the vaccine candidate, a process which allows for a faster approval of a treatment.

The company on Tuesday also said it was on track to deliver about 500 million doses per year and possibly up to 1 billion doses per year, beginning in 2021.

It has tied up with manufacturing partners Lonza of Switzerland and ROVI of Spain, for manufacturing and fill-finish outside of the United States, to supply the vaccine to Europe and other countries outside U.S.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Krishna Chandra Eluri and Patrick Graham)

Pfizer to start pilot delivery program for its COVID-19 vaccine in four U.S. states

(Reuters) – Pfizer Inc. has launched a pilot delivery program for its experimental COVID-19 vaccine in four U.S. states, as the U.S. drugmaker seeks to address distribution challenges facing its ultra-cold storage requirements.

Pfizer’s vaccine, which was shown to be more than 90% effective in preventing COVID-19 based on initial data, must be shipped and stored at -70 degrees Celsius (minus 94°F), significantly below the standard for vaccines of 2-8 degrees Celsius (36-46°F).

“We are hopeful that results from this vaccine delivery pilot will serve as the model for other U.S. states and international governments, as they prepare to implement effective COVID-19 vaccine programs,” Pfizer said in a statement on Monday.

It picked Rhode Island, Texas, New Mexico, and Tennessee for the program after taking into account their differences in overall size, diversity of populations, immunization infrastructure, and need to reach individuals in varied urban and rural settings.

The four states will not receive vaccine doses earlier than other states by virtue of the pilot, nor will they receive any differential consideration, Pfizer said.

The company expects to have enough safety data on the vaccine from the ongoing large scale late-stage trials by the third week of November before proceeding to apply for emergency use authorization (EUA).

Pfizer and its partner BioNTech SE have a $1.95 billion deal to supply 100 million doses of the vaccine to the U.S. government, which has an option to acquire up to an additional 500 million doses.

Earlier on Monday, rival Moderna Inc. said its experimental vaccine was 94.5% effective in preventing COVID-19 based on interim data from a late-stage trial, boosting hopes that vaccines against the disease may be ready for use soon.

Both the Pfizer and Moderna vaccines use a new technology called synthetic messenger RNA to activate the immune system against the virus.

(Reporting by Shubham Kalia in Bengaluru; Editing by Anil D’Silva and Richard Pullin)

Moderna could begin analyzing COVID-19 vaccine data within days, says Fauci

By Manas Mishra and Dania Nadeem

(Reuters) – Moderna Inc. could have data from a large trial of its experimental COVID-19 vaccine anywhere between “a couple of days” to “a little more than a week”, the top U.S. infectious disease expert said on Wednesday.

A high degree of effectiveness for the vaccine would make sense as it was “almost identical” to the Pfizer shot, Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, said at a conference organized by the Financial Times.

“It may not be 95%, it might be 90%, or 96%, or 89%, but it is going to be up there,” he said.

Hopes of the world soon getting an effective vaccine against the virus that has killed over a million people were raised on Monday after Pfizer Inc. said its COVID-19 vaccine was more than 90% effective based on interim trial results.

Moderna, which uses a technology similar to Pfizer’s, said earlier on Wednesday that its November timeline for initial data was on track.

It did not immediately respond to a Reuters request for comment on when it would disclose the data, though the company has said it would publish the data as soon as it is available.

The company would still have to wait for two-month follow up data on safety, which is expected in the second half of this month, before applying for U.S. emergency use authorization.

Earlier in the day, Chief Executive Officer Stephane Bancel said at a Credit Suisse conference the world would have to wait for more data to understand whether the use of a particular vaccine would be more widespread.

There are no vaccines that have gained global approval yet, although a handful, including Moderna’s, are in late-stage studies.

Moderna’s shares were up roughly 7% at $81.25 in afternoon trading.

(Reporting by Manojna Maddipatla, Manas Mishra and Dania Nadeem in Bengaluru; Editing by Saumyadeb Chakrabarty and Sriraj Kalluvila)

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)