Pfizer to Enroll Kids as Young as 12 in COVID-19 Vaccine Study | Top News

(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)

Copyright 2020 Thomson Reuters.

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J&J Pauses Coronavirus Vaccine Trials Due to Unexplained Illness | Top News

(Reuters) – Johnson & Johnson

has paused clinical trials of its coronavirus vaccine candidate due to an unexplained illness in a study participant, delaying one of the highest profile efforts to contain the global pandemic.

The move comes around a month after AstraZeneca

also suspended trials of its experimental coronavirus vaccine – which uses a similar technology – due to a participant falling ill.

J&J said on Monday the illness was being reviewed by an independent data and safety monitoring board as well as the U.S. group’s clinical and safety physicians.

The company, which reports quarterly financial results on Tuesday morning, said such pauses are normal in big trials, which can include tens of thousands of people.

It added the voluntary “study pause” in giving doses of the vaccine candidate was different from a “regulatory hold” imposed by health authorities.

AstraZeneca last month paused late-stage trials of its experimental coronavirus vaccine developed with the University of Oxford due to an unexplained illness in a British study participant.

While AstraZeneca’s trials in Britain, Brazil, South Africa and India have since resumed, its U.S. trial is still on hold, pending a regulatory review.

The J&J and AstraZeneca vaccines are both based on a so-called adenovirus, a harmless modified virus that instructs human cells to produce vaccine proteins.

They are both also part of the U.S. government’s Operation Warp Speed programme to support vaccine development.

“This could be a second case of adenoviral vaccine to spur safety concerns,” said Bryan Garnier analyst Olga Smolentseva.

AstraZeneca and medical experts say trial suspensions to look into the cause of a participant’s illness are not uncommon. Underwriters of clinical trial insurance have said premiums for coronavirus vaccines studies are only marginally higher than for pre-pandemic vaccines.

J&J on Sept. 22 became the fourth Warp-Speed participant to enter the final stage of testing on humans, with the aim of enrolling 60,000 volunteers in the United States and abroad.”Everybody is on the alert because of what happened with AstraZeneca,” Dr. William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine, said by email, adding it could take a week to gather information.

“This is likely to be a neurological event,” he said. Last month, J&J said its vaccine candidate produced a strong immune response in an early-to-mid stage clinical trial. This prompted the company to start the large scale trial, with results expected by the end of this year or early 2021.

J&J declined to elaborate on the illness due to privacy concerns. It did say some participants in studies get placebos, and it was not always clear whether a person suffering a serious adverse event in a trial received a placebo or the treatment.

Stat News reported https://www.statnews.com/2020/10/12/johnson-johnson-covid-19-vaccine-study-paused-due-to-unexplained-illness-in-participant/?utm_content=buffer37312&utm_medium=social&utm_source=twitter&utm_campaign=twitter_organic the pause earlier, citing a document sent to outside researchers, which stated that a “pausing rule” had been met, the online system used to enroll patients in the study had been closed and the data and safety monitoring board would be convened.

(Reporting by Ayanti

Abbott Wins U.S. Emergency Use Authorization for New COVID-19 Antibody Test | Top News

(Reuters) – Abbott Laboratories said on Monday the U.S. Food and Drug Administration has issued an emergency use authorization for its lab-based COVID-19 antibody blood test.

The test, AdviseDx, can be used to identify a type of antibody called Immunoglobulin M (IgM) in blood samples to determine if someone has been exposure to the novel coronavirus, potentially indicating a recent or prior infection.

Abbott has already received emergency use authorization for seven tests, including molecular tests, a rapid antigen test and another test which can detect a type of antibody called IgG.

The FDA’s emergency use authorization allows the use of unapproved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases with no adequate or approved alternatives.

IgG is longer lasting in the body after an infection, but IgM is more useful for determining a recent exposure to the coronavirus as these antibodies become undetectable weeks to months following an infection, Abbott said http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20201012:nPn8KFxtXa.

Unlike molecular tests, which can detect whether someone has the coronavirus, antibody tests determine if someone has had a previous infection by detecting disease-fighting proteins called antibodies.

However, antibody tests are not recommended as the sole basis of diagnosis of COVID-19 as these antibodies may not be detected in the early days of the infection.

Shares of Abbott were up 0.5% at $110.21 in early trading.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Amy Caren Daniel)

Copyright 2020 Thomson Reuters.

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As Globe Gallops Into Vaccine Trials, Insurers Remain Unfazed | Top News

By Noor Zainab Hussain, Carolyn Cohn and Ludwig Burger

LONDON/FRANKFURT (Reuters) – The world is racing towards a vaccine in record time, stirring public concerns about safety to the extent that nine leading developers have felt compelled to issue a pledge to uphold scientific standards and testing rigour.

Yet, while more than 40 experimental COVID-19 vaccines are being tested on humans, the insurance companies with decades of experience in assessing the risks of clinical trials don’t see anything to be unduly concerned about.

Executives at insurer Allianz and brokers Gallagher and Marsh, among the leading players in clinical trials insurance, told Reuters that premiums had only marginally increased so far in the current pandemic.

They argued there was little structural difference to trials carried out in the past, despite drugmakers around the world competing to shatter the fastest time in history for developing a vaccine, which stands at around four years.

“Rates have been relatively stable. Even this year we have so far seen only moderate price increases on average, with higher price jumps for particularly exposed COVID-19 trials,” said Mark Piazzi, senior underwriter liability at Allianz Global Corporate & Specialty (AGCS).

This was echoed by David Briggs, managing director, life sciences practice at Gallagher, who said every trial was rated on its methods and the kinds of patients involved.

Gallagher said premiums in Britain, for example, started at about 5,000 pounds ($6,500) per trial.

Total claims limits in policies were typically set at roughly $6-12 million, depending on the country’s rules, according to several insurance companies interviewed by Reuters.

In Britain, for instance, claim limits were usually set at no lower than 5 million pounds, while in Germany the figure was around 10 million euros ($11.8 million).

‘LOSS EXPERIENCE NOT DRAMATIC’

However part of the reason why premiums have not risen as sharply as some people might have expected is that claims from trial are generally uncommon, according to executives. This is because patients have often signed so-called informed consent agreements, they said.

Jim Walters, managing director of Life Sciences & Chemical Group at broker Aon, said such agreements outlined the risks that patients were taking by participating in the trial.

“So, you know, everything from you could have a sore spot on your arm. To you could potentially die. And you know, they would literally go that far in some of these protocols,” he added.

“Those generally tend to hold up in courts and in legal systems around the world. That means that the loss experience coming out of clinical trials is not very dramatic.”

Claims are often limited to circumstances linked to the improper conduct of trials or any wrongdoing, rather than side-effects of the treatment, executives said.

Such have been the worries about the vaccine race among some members of the public, who fear safety standards could slip, that nine developers issued a joint pledge last month to “uphold the integrity of the scientific process”.

ASTRAZENECA TRIAL SUSPENSION

AstraZeneca and Oxford University’s suspension of global Phase

Defender Surender Kumar focused on returning to top fitness level

New Delhi [India], October 12 (ANI): Indian men’s hockey team defender Surender Kumar has said that he is focused on returning to his top fitness level.

In early August, Surender Kumar was among the six players who had tested positive for COVID-19.

“I would often tell myself that so many people around the globe have battled this virus including top sportspeople and have come out of it. It was a difficult phase but I am really grateful for the kind of support system we had from Hockey India and SAI who made every effort to get us the best treatment,” said Surender in an official Hockey India release.

“The coaching staff ensured we were in a good space mentally for that entire period of 2-3 weeks where we were in the hospital followed by mandatory isolation,” stated the defender from Karnal Haryana who was part of the Indian Team for Rio Olympics in 2016.

Having returned to the pitch in mid-September and join the rest of the team, Surender’s main aim is to gain full fitness. “I am happy to be back to the regular schedule with the rest of the Core Group. Initially, Chief Coach would emphasis on taking it slow and not exerting too much even though we would feel no discomfort in pushing ourselves. It’s now been over 3 weeks since I have returned to training. I am feeling good and aiming to hit top fitness levels,” said Surender.

Unlike his other compatriots who had tested positive and recovered, Surender had developed venous thrombosis, a condition in which there are blood clots. It is one of the many complications related to the COVID-19 recovery phase.

“Again, I am grateful to Hockey India and SAI for ensuring my recovery is closely monitored. I get my routine check-ups done regularly. We also have a doctor on campus who I can consult in case of any discomfort. I feel we are just fortunate to have this kind of support. My focus now is on hockey,” Surender said. (ANI)

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Wisconsin to Open Field Hospital as COVID-19 Hospitalizations Surge | Top News

(Reuters) – Wisconsin will open a field hospital outside of Milwaukee to handle a surge in COVID-19 cases that have overwhelmed hospitals across the state, Governor Tony Evers said on Wednesday.

The hospital will open within the next week after hospitalizations across the state nearly tripled over the last month. There were 853 patients hospitalized with COVID-19 as of Tuesday, an increase of 71 from the day before, Evers said in a statement.

“Yesterday I learned our health care systems were teetering and that they are on the brink,” Evers said during a news conference. “We hoped this day won’t come but Wisconsin is in a much different, dire place today.”

The 530-bed facility, built last spring, is located at the Wisconsin State Fair Park in West Allis, just west of Milwaukee. It will not accept walk-in patients, but will treat patients who are transitioning out of the hospital and require less medical care, Ever said.

A total of 55 of Wisconsin’s 72 counties meet the threshold of very high disease activity level, an increase of 10 counties over the last week. Wisconsin’s remaining counties are at a high activity level, Wisconsin Department of Health Services Secretary-designee Andrea Palm said.

“Every region in Wisconsin has hospitals reporting current and imminent staffing shortages,” she said. “Our state is in a danger place.”

Wisconsin is one of a handful of U.S. states, including the Dakotas and Montana, that are seeing record hospitalizations. A Reuters tally shows Wisconsin has about 15 hospitalizations per 100,000 residents, three times more than it did in June.

The state is also experiencing a spike in its seven-day average positivity rate by person, which stands at 17% after it was 11% a month ago, state data showed.

“Wearing a mask is simply not enough to flatten the curve. I’m once again calling on Wisconsinites to hunker down,” Evers said.

(Reporting by Brendan O’Brien in Chicago; Editing by Chizu Nomiyama and Marguerita Choy)

Copyright 2020 Thomson Reuters.

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VA Coronavirus Hospitalizations Top 1K, Positive Rate Below 5%

VIRGINIA — The Virginia Department of Health reported 509 new cases of the coronavirus on Wednesday, down from 625 new cases on Tuesday. In Virginia, there have been 153,691 cumulative coronavirus cases, 11,345 hospitalizations and 3,303 deaths.

COVID-19 hospitalizations stand at 1,003 patients statewide as of Wednesday, the first time they have climbed above 1,000 since Sept. 16 when they reached 1,027. That includes 240 in the central region, 234 in the eastern region, 217 in the northern region, 194 in the southwest region and 118 in the northwest region.

According to the Virginia Hospital & Healthcare Association, the current hospitalizations include 228 in the intensive care units and 109 on ventilators.

Ventilator use stands at 22 percent among all Virginia hospital patients, and ICU occupancy is at 80 percent. There are no hospitals reporting difficulty obtaining personal protective equipment in the next 72 hours. According to the association, 18,189 COVID-19 total patients have been discharged from hospitals as of Wednesday.

The seven-day average of new coronavirus cases has been below 1,000 since Sept. 18 and now stands at 774. On Wednesday, the southwest region led the state with 124 new cases of the coronavirus, followed by the northern region with 124 cases, the northwest region with 81, the central region with 65 and the eastern region with 58.

The seven-day positive average of PCR tests in Virginia is 4.8 percent as of Oct. 3. The regional averages are 4.4 percent in the northern region, 4.5 percent in the central region, 4.6 in the eastern region, 4.9 percent in the northwest region and 6.4 percent in the southwest region. There have been 2,170,313 PCR tests completed as of Wednesday, an increase of 26,145 from Tuesday.

Here are the latest coronavirus data updates for our coverage area between Tuesday and Wednesday:

  • Alexandria: 3,938 cases, 327 hospitalizations, 71 deaths; increase of six cases

  • Arlington County: 4,083 cases, 508 hospitalizations, 152 deaths; increase of 15 cases

  • Fairfax County: 21,447 cases, 2,180 hospitalizations, 594 deaths; increase of 33 cases and two deaths; removal of one hospitalization

  • Fairfax City: 140 cases, 13 hospitalizations, eight deaths; removal of one hospitalization

  • Falls Church: 72 cases, 13 hospitalizations, seven deaths; no changes

  • Loudoun County: 7,042 cases, 441 hospitalizations, 127 deaths; increase of 16 cases and one death

  • Manassas: 1,961 cases, 130 hospitalizations, 24 deaths; increase of seven cases

  • Manassas Park: 619 cases, 56 hospitalizations, eight deaths; increase of three cases and one hospitalization

  • Prince William County: 12,855 cases, 931 hospitalizations, 208 deaths; increase of 44 cases

  • Fredericksburg: 554 cases, 50 hospitalizations, five deaths; increase of one case

  • Spotsylvania County: 2,197 cases, 137 hospitalizations, 46 deaths; increase of two cases and one hospitalization

  • Stafford County: 2,082 cases, 161 hospitalizations, 18 deaths; increase of one case

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This article originally appeared on the Ashburn Patch

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Huma Mirza, D.D.S. of Smile! Dental Boutique in Warren, New Jersey Named 2020 NJ Top Dentist

SCOTCH PLAINS, N.J., Oct. 7, 2020 /PRNewswire-PRWeb/ — Huma Mirza, DDS of Smile! Dental Boutique in Warren, New Jersey has been reviewed and approved by NJ Top Dentists for 2020. Dr. Mirza provides a full spectrum of general dentistry and cosmetic dentistry services at her Warren, New Jersey office. She has expertise with porcelain veneers, dental implants, crowns, and bridges.

Dr. Mirza’s key mission as a dentist is to provide her patients with a new, positive outlook on dentistry.

Dr. Mirza graduated from United Medical and Dental School of Guys’, Kings and St Thomas’ in London in 2002. This is one of the most prestigious dental schools in the United Kingdom. She graduated at the top of her class, winning prizes in orthodontics, pediatric dentistry, dental public health, microbiology, immunology, pathology, conservative dentistry, and was entered to win the Gold Medal prize for best dental student in London, in which she achieved the runner up position.

Upon graduating she married and moved to America where she attended NYU College of Dentistry graduating in 2006 with the highest GPA in her class. She was on the Dean’s list for all 3 years at NYU and won the Ethics prize and a certificate of achievement in recognition of outstanding achievements. Dr. Mirza then took part in the honors program in Oral Surgery, and was inducted into the omega chapter of OKU, an elite dental society joined by invitation only. Upon graduating from dental school Dr. Huma has taken extensive continuing education classes to improve her skill range, enabling her to be able to provide an extensive range of treatments for her patients, and helping her keep abreast of new technologies available.

Whether you need a simple filling or a full cosmetic reconstruction, Dr. Mirza has the knowledge, expertise and equipment to meet your needs with the best treatment the industry has to offer.

To learn more about Dr. Huma Mirza and her practice, Smile! Dental Boutique please visit: https://njtopdocs.com/nj-dentists/drhumamirza/

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About Us

NJ Top Dentists is a division of NJ Top Docs. NJ Top Docs is a comprehensive, trusted and exclusive healthcare resource featuring reviewed and approved Top Doctors and Dentists in New Jersey online in an easy to use format. NJ Top Docs only reviews and approves providers based on merit after they have been extensively vetted.

NJ Top Docs is a division of USA Top Docs which allows patients to meet providers online before making their appointment.

For more information, please click here to contact us or visit http://www.NJTopDocs.com.

You can also follow us on Facebook, Twitter, & Instagram.

 

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Q&A: Where Are We in the COVID-19 Vaccine Race? | Top News

NEW YORK (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.

As some companies close in on unveiling their initial findings – with Canadian and European regulators already reviewing early data on some vaccines – the following is what we know about the race to deliver vaccines to help end the coronavirus pandemic that has claimed over a million lives:

U.S. drugmaker Pfizer Inc with German partner BioNTech SE <22UAy.F>, U.S. biotech Moderna Inc

and Britain-based AstraZeneca Plc

in conjunction with University of Oxford researchers could provide early analyses of data from their various large trials over the next two months. Johnson & Johnson

is not far behind.

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. Neither trial participants nor researchers know who has received the vaccine or placebo until the data is ready for review, or unblinded. The studies rely on subjects becoming naturally infected with COVID-19, so how long it takes to generate results largely depends on how pervasive the virus is where the trials are being conducted. In areas with large outbreaks and community spread, infections will pile up faster.

How will we know if the vaccine works?

The United States, the European Union, the United Kingdom and the World Health Organization have all set similar minimum standards for effectiveness. Vaccines must demonstrate at least 50% efficacy – meaning at least twice as many infections among volunteers who got a placebo than in the vaccine group. Independent panels oversee the trials to monitor for safety and effectiveness since the data is hidden from companies and researchers. These data safety monitoring boards take a peek at the interim results at pre-determined milestones, such as after a certain number of people have become infected. It the vaccine is looking significantly better than the placebo, the companies can apply for emergency use, and the study may be halted or continue to its intended conclusion. A trial also can be halted if the panel determines the vaccine to be unsafe.

Will regulators ensure a vaccine is safe before making it available to the public?

The U.S. Food and Drug Administration has said it will not approve a vaccine unless it is both effective and safe. On Tuesday, it added more stringent safety guidelines for U.S. vaccines. The FDA wants developers to follow trial subjects for at least two months after they receive their final vaccine dose to check for any side effects that may crop up. The agency will consider an emergency use authorization (EUA) once that data is collected from at least half of the trial’s participants. The UK Medicines and Healthcare products Regulatory Agency will review the vaccines

U.S. FDA Safety Guidelines Likely to Push COVID-19 Vaccine Authorization Past Election | Top News

By Michael Erman and Manas Mishra

(Reuters) – The U.S. Food and Drug Administration told coronavirus vaccine developers on Tuesday it wants at least two months of safety data before authorizing emergency use, a requirement that would likely push any U.S. vaccine availability past the Nov. 3 presidential election.

A senior administration official confirmed the White House had approved the plan, which undercuts President Donald Trump’s hopes of getting a vaccine before voters go to polls.

Trump voiced his displeasure in a Twitter post late on Tuesday: “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!”

The FDA released the guidance laying out more stringent recommendations for drugmakers hoping to apply for an emergency use authorization (EUA) for their experimental vaccines.

The New York Times reported on Monday that the guidelines had been blocked by the White House. The senior administration official said there he had been no holdup of the guidance, which underwent normal regulatory review.

The move is the latest effort by U.S. officials to play down politics around the vaccine and assure public safety.

“Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate and is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” Dr. Peter Marks, director of the FDA division responsible for approving vaccines, said in a statement.

The White House could still force authorization of a vaccine without that additional safety data. Doing so would put it in open disagreement with the FDA and its career scientists, and add to the perception that politics was playing a role in pushing out a vaccine.

If the agency follows its own guidelines, it is unlikely to authorize a vaccine before sometime in late November. It wants two months of data from half of a trial’s volunteers.

Pfizer Inc and partner BioNTech <22UAy.F> are expected to be the first to announce results from a late-stage U.S. clinical trial.

About half the volunteers in the 44,000-subject Phase III trial had received the second dose of the two-shot vaccine by late September.

Pfizer had previously said it expected to release efficacy data as early as this month and provide FDA with safety data, including the median of two months’ safety data after the second dose, on a rolling basis.

The head of the U.S. government’s Operation Warp Speed vaccine development program said on Tuesday efficacy data on one or two vaccines will be available within the next month or two, and that there should be enough supply to immunize 30 million people during November and December.

Moderna Inc

appears likely to be the second company after Pfizer that will have U.S. trial data available for an EUA review.

Pfizer Chief Executive Albert Bourla tweeted on Tuesday that the company had not discussed the FDA’s standards with the White House, saying that could compromise the agency’s independence.