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Pfizer to enroll kids as young as 12 in COVID-19 vaccine study

(Reuters) – Pfizer Inc will enroll participants as young as 12 in its large, late-stage COVID-19 vaccine trial to understand how it works in a wider age group.

While severe COVID-19 symptoms are extremely rare in infected children, they can pass on the virus to high-risk groups such as the elderly.

That makes determining the effectiveness of a potential vaccine in children crucial, as vaccines work differently in kids and adults, the FDA said in its guidelines https://www.fda.gov/media/139638/download in June.

The U.S. Food and Drug Administration (FDA) granted permission to the drugmaker and German partner BioNTech SE to enroll younger participants this month, according to an update on the U.S. company’s website https://www.pfizer.com/science/coronavirus/vaccine on Monday.

Last month, Pfizer scaled up its trial to about 44,000 participants, from up to 30,000, to enroll people as young as 16 and those with chronic, stable HIV, hepatitis C and hepatitis B.

The company said on Tuesday it would enroll children in its study based on satisfactory safety data in older adolescents and young adults, but did not specify a timeline.

Pfizer is racing to develop a safe and effective vaccine for the new coronavirus with rivals such as Moderna Inc, AstraZeneca Plc and Johnson & Johnson.

Late-stage vaccine trials initiated by Moderna, J&J and Novavax Inc are testing their respective candidates only in adults.

AstraZeneca’s U.K. vaccine trial, targeting more than 12,000 volunteers, will have one out of 11 subgroups with children 5 to 12 years of age. Chief Executive Officer Pascal Soriot said last month that tests on children had not yet started.

(Reporting by Manojna Maddipatla in Bengaluru and Ludwig Burger in Frankfurt; Editing by Sriraj Kalluvila and Shinjini Ganguli)

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Pfizer to start testing its Covid-19 vaccine in kids as young as 12

It will be the first coronavirus vaccine trial to include children in the United States.

A team at Cincinnati Children’s Hospital will begin vaccinating teenagers aged 16 and 17 this week, and will move to enroll 12-to 15-year-olds later, said Dr. Robert Frenck, director of the Vaccine Research Center at the hospital.

The company confirmed on its website it has approval from the US Food and Drug Administration to enroll children as young as 12 in its trial.

“We really think a vaccine for adolescents and children is going to be critical for getting Covid under control,” Frenck told CNN in a telephone interview.

“I think one of the things that is important to remember is that although the death rate for children with Covid is lower than in older adults, it’s not zero,” he saId, noting that more than half a million children have been diagnosed with coronavirus in the US. “It is not a nonexistent infection in children.”

Children can develop serious illness and also die from coronavirus and there is no way to predict which ones will, he said. They also can spread it to other, more vulnerable people, including parents, grandparents, healthcare workers and others. And children can develop a rare but serious side-effect from coronavirus infection called multisystem inflammatory syndrome in children or MIS-C.
Kids struggle with Covid-19 and its months of aftermath

Frenck also believes more children have been infected with coronavirus than the official data show. “I think we are probably under detecting the number of kids that are infected because they are not getting sick enough to where a parent says they need to go to a doctor,” he said.

“Most of the time in kids, you have a young kid at home and they have a runny nose, they have a cough — you are not going to bring them to a doctor,” he added.

“And most of the time, what a coronavirus causes is a cold.”

Plus, the FDA has asked the companies working to make a coronavirus vaccine to test them in diverse groups — including in people usually missed in drug and vaccine trials, such as the elderly, Blacks, Hispanics and Native Americans.

New ads encourage minorities to roll up their sleeves and participate in coronavirus vaccine trials

Pfizer, one of four companies to have vaccines in advanced, Phase 3 clinical trials in the US, says it has enrolled close to 38,000 volunteers in its trial. More than 31,000 of them have received the second of two shots.

Frenck said more than 90 people have responded to an ad looking for volunteers to sign up teens for the trial.

Pfizer developed its two-dose coronavirus vaccine with Germany’s BioNtech. It uses pieces of viral genetic material to induce immunity to the coronavirus.

“If regulatory approval or authorization is obtained, the companies expect to manufacture globally up to 100 million doses by the end of 2020 and potentially 1.3 billion doses by the end of 2021,” the company said on its website.

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U.S. vaccine program head Slaoui expects Pfizer, Moderna vaccine data readouts in November-December

(Reuters) – The chief adviser for the U.S. government’s Operation Warp Speed COVID-19 vaccine program, Moncef Slaoui, on Tuesday said efficacy data readouts are expected from Pfizer Inc and Moderna Inc between next month and December.



a man wearing a suit and tie: U.S. President Trump holds coronavirus response event in the Rose Garden at the White House in Washington


© Reuters/Kevin Lamarque
U.S. President Trump holds coronavirus response event in the Rose Garden at the White House in Washington

Speaking at a symposium conducted by the Johns Hopkins University and the University of Washington, Slaoui said data readouts from leading vaccine developers are expected to come in three waves over the next several months.

The first wave would be coming from Pfizer and Moderna, both of which are developing mRNA-based vaccines for the coronavirus, he said.

Slaoui said efficacy data on one or two vaccines will be available within the next month or two, for which there will be enough doses to immunize 30 million people between November and December.

Commenting on AstraZeneca’s vaccine program, Slaoui said while the company’s U.S. study remains on hold, data readouts on the vaccine’s effectiveness may be expected somewhere in late October or November from ongoing studies in the UK, Brazil and South Africa.

“At that time, we will have very few doses to be able to, if the decision was to approve the vaccine, immunize,” he said, adding that efforts are in place to scale up manufacturing and stockpiling of the vaccine.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Andrea Ricci)

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Pfizer, BioNTech, Regeneron Hit With Patent Lawsuits Over COVID-19 Drugs And Vaccines

Three top names in the fight against the coronavirus and the COVID-19 disease that can result from it have been sued for patent infringement. The trio includes Regeneron Pharmaceuticals (NASDAQ:REGN), Pfizer (NYSE:PFE), and BioNTech (NASDAQ:BNTX). The plaintiff is privately held Allele Biotechnology and Pharmaceuticals.

Allele alleges that the three all used its mNeonGreen fluorescent protein to develop their COVID-19 products without paying royalties for the substance. Medical researchers inject fluorescent proteins into cells to track reactions within those bodies. This tracking is used to help determine the effect of medicines and vaccines on the body.

Regeneron is currently developing REGN-COV2, an experimental cocktail of two antibodies to treat COVID-19. The company became a hot topic last week when it was revealed President Donald Trump was administered REGN-COV2 as part of his treatment for COVID-19.

Pfizer and BioNTech have teamed up to develop a coronavirus vaccine; their candidate, BNT162b2, is considered one of the front-runners in the race to bring a vaccine to market.

mNeonGreen was allegedly used in both programs. Allele said in its complaint, filed in a California federal court, that “only through the use of mNeonGreen” were the companies able to develop their products with relative speed.

This, in turn, allowed them to be awarded “an immediate $400 million in grants and over $4 billion in sales of the vaccine to date,” although BNT162b2 has, like other candidates, not yet been approved for use by any major pharmaceutical regulator. Allele is seeking to recover the royalties for its product, although it wasn’t immediately clear how much it is requesting.

Regeneron said it disagreed with Allele’s complaint and would “vigorously defend” its position in court. Neither Pfizer nor BioNTech has formally reacted to the lawsuit.

This article originally appeared in the Motley Fool.

Eric Volkman has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

The Pfizer company logo is seen in front of Pfizer's headquarters in New York The Pfizer company logo is seen in front of Pfizer’s headquarters in New York Photo: AFP / Don EMMERT

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Pfizer CEO pushes back against Trump claim on vaccine timing

The head of Pfizer, one of the drugmakers racing to develop a coronavirus vaccine, told employees he was disappointed that its work was politicized during this week’s presidential debate and tried to reassure U.S. staff that the company won’t bend to pressure to move more quickly.

Chief Executive Officer Albert Bourla told the employees Thursday that the company is “moving at the speed of science,” rather than under any political timing, according to a staff letter obtained by The Associated Press.

“The only pressure we feel — and it weighs heavy — are the billions of people, millions of businesses and hundreds of government officials that are depending on us,” Bourla wrote.


Despite top U.S. federal health officials repeatedly stating that a vaccine is unlikely to be available widely until 2021, President Donald Trump has insisted that a vaccine will be ready before Election Day.

During Tuesday’s debate with former Vice President Joe Biden, Trump said he had talked with the companies whose experimental vaccines are furthest along in testing.

“I’ve spoken to Pfizer, I’ve spoken to all of the people that you have to speak to, Moderna, Johnson & Johnson, and others. They can go faster than that by a lot,” Trump claimed. “It’s become very political.”

Pfizer has said that it expects to have data from its ongoing late-stage test by October that could show whether the vaccine is safe and effective. In his letter to employees, Bourla wrote that the company hopes to have “a hundred million doses delivered by the end of the year.”

Those doses could not be distributed until the Food and Drug Administration reviews Pfizer’s data and decides whether to issue what’s called an emergency use authorization. That would allow distribution of the vaccine on a limited basis, with initial shots expected to go to medical and other frontline workers, nursing homes and people most at risk of catching or becoming seriously ill from the virus.

Moderna’s chief executive, Stéphane Bancel, told the UK’s Financial Times on Wednesday that Moderna would not be ready to seek emergency use authorization from the FDA for its vaccine candidate before Nov. 25 at the earliest.

Johnson & Johnson just started the late-stage and final patient study of its vaccine last week.

And AstraZeneca, which has a candidate in late-stage trials around the world, has its U.S. study on hold while the FDA reviews a possible safety problem.

Bourla and top executives of eight other companies developing COVID-19 vaccines and treatments pledged in early September not to seek even emergency use authorization, let alone a full approval of their products, until they were proven safe and effective.

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Johnson reported from Fairless Hills, Pennsylvania. Lemire reported from Washington.

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Follow Linda A. Johnson at https://twitter.com/LindaJ_onPharma

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