Category Archives: In the News

What you need to know about J&J’s newly authorized one-shot COVID-19 vaccine

In the News, News Stories & Editorials, We're In the News, , , , ,

Tina Hesman Saey, ScienceNews: February 27, 2021

And then there were three: A single-shot vaccine is the latest weapon to join the battle against COVID-19 in the United States.

On February 27, the U.S. Food and Drug Administration gave emergency use authorization for Johnson & Johnson’s vaccine against SARS-CoV-2, the coronavirus that causes COVID-19. South Africa is the only other country to OK Johnson & Johnson’s vaccine so far, though other countries are poised to follow suit.

The FDA determined that Johnson & Johnson’s vaccine meets the criteria for safety and effectiveness and that there is clear evidence that it may prevent COVID-19, the agency said in a statement.

“With today’s authorization, we are adding another vaccine in our medical toolbox to fight this virus,” said Peter Marks,  director of the FDA’s Center for Biologics Evaluation and Research.

Its authorization for emergency use in the United States – for people age 18 and older – follows similar authorizations in December for vaccines made by Moderna and by Pfizer and its German partner BioNTech.

[….]

As of February 25, more than 52,000 people were hospitalized in the United States fighting COVID-19, according to the COVID Tracking Project. That’s down from the record-setting daily peaks of more than 130,000 in early January and the lowest since early to mid-November. More than half a million people in the United States have now died from COVID-19.

In Johnson & Johnson’s clinical trial, two of the 19,514 people in the vaccine group were hospitalized with COVID-19 starting 14 days after vaccination. That compares with 29 hospitalizations among the 19,544 people in the placebo group. None of the vaccinated people died, but there were seven deaths related to COVID-19 in the placebo group. Those numbers are small and some researchers say the data aren’t clear-cut on the benefits.

“The data indicate that the vaccine is effective, but doesn’t prove that the vaccine is especially effective against moderate to severe COVID,” said Diana Zuckerman, president of the National Center for Health Research, a Washington, D.C.–based think tank that analyzes health research.

The data were also collected after only two months of follow-up. Normally, the FDA requires a year or more of data to fully approve a vaccine. Some questions about the vaccine can’t be answered with less than six months of data, Zuckerman said during a public comment period in the Feb. 26 advisory board hearing.  “Let’s be very honest with the public about what we do know and what we won’t know” for some time to come.

For all the vaccines, no one knows how long immunity will last. And what’s already authorized might need to be tweaked if resistant variants become widespread. Booster shots may be needed, Benjamin says.

[….]

To read the entire article, click here.

Who Will Be the Next F.D.A. Chief?

We're In the News,

Sheila Kaplan, New York Times: February 20, 2021

One month into his presidency, President Biden still has not named a candidate to head the Food and Drug Administration, a critical position at a time when new vaccines and coronavirus treatments are under the agency’s review.

The glaring vacancy lags behind the president’s selections of most other top government health posts, and has spurred a public lobbying campaign by supporters of the two apparent front-runners, Dr. Joshua Sharfstein, a former high-ranking F.D.A. official and Dr. Janet Woodcock, the acting commissioner.

It has also exposed rifts among Congressional lawmakers, within the public health and medical communities as well as the health and drug industries that depend on the F.D.A. for approval of their products. In particular, some public health officials have used the open position to debate the leadership qualifications needed to restore the agency’s morale and credibility after a year fighting both a pandemic and a president who often belittled the F.D.A.’s process for approving treatments and vaccines.

Administration officials say that Dr. Sharfstein and Dr. Woodcock have gone through at least partial vetting for the job. They attributed the delay to their focus on solving Covid vaccine shortages and distribution problems. They also noted that Xavier Becerra, the attorney general of California and who Mr. Biden has nominated for secretary of the Health and Human Services Department, faces Republican opposition that could jeopardize his confirmation.

[….]

Dr. Woodcock’s decades of service at the F.D.A. have made her more of a target for critics, and she has drawn particular fire over her agency roles during the opioid crisis.

Dr. Sharfstein, who held the No. 2 slot at the F.D.A. for nearly two years in the Obama administration, has extensive public health interests. At 51, he is a prolific writer, with more than 100 articles, editorials and journal papers published in the past few years on subjects ranging from training physicians to treating opioid addiction to reducing drug prices. He often criticized the Trump administration’s pandemic response, and called for the F.D.A. to “stand up for itself and for science, not politics.”

Early in the coronavirus outbreak, Dr. Sharfstein urged public health officials to focus on protecting racial and ethnic minorities, poor people and others who face social inequities. He has called for expanding housing to hold people with mild symptoms in quarantine; protecting tenants from eviction and offering incentives to food providers to deliver food to low-income neighborhoods for free or at a discount. He also proposed a federal coronavirus insurance program.

[….]

“I think Josh would be a good choice,” said David Nexon, a former executive at the Advanced Medical Technology Association, known as AdvaMed. “He’s a very smart guy, very committed to public health and he has a broad public health background, which would be an asset because of F.D.A.’s wide-ranging responsibilities.”

Dr. Woodcock, 72, also commands deep support, especially within the vast network of cancer-related patient advocacy groups, researchers and the drug companies that help finance them. But Dr. Woodcock, who has spent over 36 years working for the agency, has also generated much stiffer opposition in this round than Dr. Sharfstein.

“In the past, even when the F.D.A. review of the drug was scathing, quite often Janet Woodcock or another high level F.D.A. official would be at the meeting, clearly pushing the advisory committee to recommend approval,” said Diana Zuckerman, president of the National Center for Health Research, a think tank and advocacy group. “But by law, these advisory committees are supposed to make recommendations independent of any F.D.A. pressure.”

But the loudest objections to Dr. Woodcock focus on the F.D.A.’s role in the opioid epidemic during her two stints as chief of its drug division, from 1994 to 2004 and then again from 2007 until she moved to Operation Warp Speed last May. (Between those two postings, she held other roles at the agency.)

In January, a group of nonprofit advocacy groups wrote to Mr. Becerra, the health secretary nominee, and Norris Cochran, the acting health secretary, saying that Dr. Woodcock’s 25-year tenure as F.D.A.’s drug division chief should disqualify her from consideration for commissioner.

“Much of the responsibility for the opioid crisis clearly rests with industry,” the group wrote. “But the fact that opioid manufacturers for decades disseminated false claims about the risks and benefits of opioids points to a dereliction of duty” by Dr. Woodcock’s division.

The letter cited a 2017 presidential commission report on the opioid crisis, which found that it was caused in part by “inadequate oversight by the F.D.A.”

Dr. Woodcock’s role in the approval of new opioid products has also drawn strong opposition from some members of Congress, including Democratic Senators Maggie Hassan of New Hampshire and Edward J. Markey of Massachusetts. Senator Joe Manchin of West Virginia, has also been very critical of the F.D.A.’s handling of opioids under Dr. Woodcock.

“Multiple past F.D.A. commissioners have acknowledged that the F.D.A. made mistakes regarding the opioid crisis, yet the agency still has not fully reckoned with its past missteps,” Senator Hassan said in an email. “The F.D.A.’s decision-making processes for the approval and labeling of opioid drugs going back decades remain of serious concern, and it’s important that the next F.D.A. commissioner is someone who has demonstrated that they have learned from the F.D.A.’s past mistakes — not someone who has been involved in repeating them.”

The nonprofit advocacy groups’ letter prompted a defense of Dr. Woodcock orchestrated in large part by Ellen Sigal, co-founder of Friends of Cancer Research. Ms. Sigal is also chairwoman of the Reagan-Udall Foundation for the F.D.A., an influential organization created by Congress to help advance the agency’s mission and to speed development of new medical treatments.

Friends of Cancer Research receives much of its funding from drug companies. The 2019 top donor list for Friends of Cancer Research includes Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly Co., Genentech, Gilead, Merck, Pfizer and PhRMA, the pharmaceutical industry trade group. The Reagan-Udall Foundation receives funding directly from the F.D.A., but also lists drug industry donors, among them: Biogen, Johnson & Johnson, Teva and the Biotechnology Innovation Organization, known as BIO, which gave Dr. Woodcock an award in 2019 in conjunction with the Science History Institute.

[….]

Dr. Sharfstein’s supporters countered with a letter on Feb. 5, signed by 18 top academic physicians and researchers. “Dr. Sharfstein knows the F.D.A. and will ensure that its decision-making is scientifically beyond reproach, transparent and based on the principles of public health,” they wrote.

[….]

To read the entire article, click here: https://www.nytimes.com/2021/02/20/health/Covid-FDA-Biden.html

FDA blasts Merck’s Keytruda data for new breast cancer indication

In the News, News Stories & Editorials, We're In the News, , , ,

Ed Silverman, Stat News: February 5, 2021

Merck (MRK5 ) may have readily turned its Keytruda cancer drug into a medical and financial juggernaut, but its bid to win regulatory approval for at least one additional use may not come so easily, judging by documents from the Food and Drug Administration. The drug maker wants to sell the medicine to combat high-risk, early-stage triple-negative breast cancer along with chemotherapy before surgery, and then by itself after surgery.

[…]

Given the FDA review, though, the likelihood of a recommendation next week is not high, according to Ira Loss of Washington Analysis, who tracks pharmaceutical regulatory and legislative matters for investors. “The agency believes, and we think the (FDA expert) committee will agree, that further data from the trial are needed to make an informed decision,” he wrote to investors.

Another FDA watcher was even more blunt. “It’s important to have good treatment because this disproportionately occurs among Black women,” said Diana Zuckerman, who heads the National Center for Health Research, a nonprofit think tank. “But they’re saying this may not be needed, may not work and may be harmful – that’s pretty damning. And there are some real safety issues that can have terrible impact on patients… This is one of the most negative reviews I’ve ever seen.”

[….]

Read the full article here

Patients Continue to Be Inadequately Informed of Risk for Breast Implant-Associated ALCL

In the News, News Stories & Editorials, We're In the News, , , , , ,

Christina Bennet, MS, Cancer Therapy Advisor: February 8, 2021

Although the risk for breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) has been well-documented, patients considering breast implants continue to be inadequately informed of the propensity for disease development. Awareness of BIA-ALCL has risen since 2020, but adequate safeguards have not yet been put in place, according to experts in the field.

“There have been efforts made [to ensure patients are informed], but they have not been successful,” Diana Zuckerman, PhD, president of the National Center for Health Research (NCHR), said in an interview with Cancer Therapy Advisor.

The most recent effort to more frontally disclose the risk for BIA-ALCL is a final guidance document released by the FDA on September 28, 2020.1 The guidance, which applies to all breast implants, advised breast implant manufacturers to add a black box warning that mentions the risks associated with breast implants such as BIA-ALCL. In the guidance, the FDA also encouraged manufacturers to incorporate a patient decision checklist in the labeling to “better ensure certain information is received and understood by patients.”1,2 Manufacturers, however, are not required to follow these recommendations.

Zuckerman, who is a member of the Breast Implant Working Group, said she was surprised by the FDA’s decision to recommend rather than require these facets of the guidance. “We don’t have the answer to that question other than we have talked to FDA officials who said that at least some of this will at some point be a requirement, but we don’t know when that is,” she said.

With no mandates in place to ensure that patients receive information about the risks for BIA-ALCL—among other breast implant-associated complications—upfront, the industry is left to educate—and this does not seem to be working.

Patient advocates Terri McGregor and Jennifer Cook, both of whom have received a BIA-ALCL diagnosis, discussed a misleading patient brochure that has further contributed to the misinformation about breast implant-associated cancer risk. Sold online by the American Society of Plastic Surgeons (ASPS), the brochure featured the symbol for breast reconstruction awareness—a modified pink ribbon—and the slogan “Closing the loop on breast cancer.”3

The brochure was sponsored by several companies, including 2 prominent breast implant manufacturers, Allergan and Mentor. Though the document was promoted on Twitter by the ASPS and users were encouraged users to “stock up now” ahead of Breast Reconstruction Day,3,4  it notably made no mention of BIA-ALCL—not even on the page that describes the risks and safety issues associated with breast implants.

Conflicts of Interest Cloud Risk Disclosure

[…]

Eric Swanson, MD, a plastic surgeon at the Swanson Center for Cosmetic Surgery in Leawood, Kansas, told Cancer Therapy Advisor that plastic surgeons’ financial ties to breast implant manufacturers are part of the reason why they have been slow to respond to the issue of BIA-ALCL. “There’s a big problem with conflict of interest in plastic surgery. Once [a person has] taken funds from a company, it is very rare for the taker to be critical of that company,” Swanson said.

[….]

Zuckerman described the ASPS brochure as “terribly” out of date. “The Institute of Medicine report is more than 20 years old, and there has been a great deal of research since then,” she said.

[….]

The ASPS Brochure: Current Status

When Cancer Therapy Advisor inquired about the content of the brochure, an ASPS representative agreed that the information was “outdated” and removed the brochure from sale on its website.

Enclosed in the ASPS brochure was a list of websites that included breastimplantsafety.org, which—despites its domain name—did not include any safety information about breast implants. Instead, the domain redirected users to a different domain, smartbeautyguide.com, the patient site for The Aesthetic Society, a professional organization for plastic surgeons. A representative for The Aesthetic Society told Cancer Therapy Advisor that breastimplantsafety.org was active until 2015, when it migrated to their patient site, Smart Beauty Guide.

“We have been developing and will launch our new Aesthetic Society website that will include a dedicated section for patient education,” the representative wrote in an email. Within days of being contacted by Cancer Therapy Advisor, The Aesthetic Society updated the breastimplantsafety.org domain name to direct users to an existing page that provides resources about breast implants, including information about BIA-ALCL and breast implant illness, a systemic condition characterized by a wide range of symptoms that is currently under FDA investigation.18

Read the full article here

A C.D.C. analysis describes anaphylaxis after people have received the Pfizer-BioNTech vaccine as ‘rare’

We're In the News, , , , ,

Roni Caryn Rabin, New York Times: January 11, 2021

Any site that administers the currently authorized vaccines must be prepared to recognize and treat a severe allergic reaction that may occur, though it is “a rare outcome,” federal health officials said.

Of the nearly 2 million Americans who received coronavirus vaccinations developed by Pfizer and BioNTech during a 10-day stretch last month, 21 experienced a serious and potentially life-threatening allergic reaction called anaphylaxis, federal health officials said Wednesday.

Although the risk is ten times higher than the risk for anaphylaxis after a seasonal flu vaccine, officials described the reaction as “a rare outcome.”

The rate of anaphylaxis following vaccination was estimated to be 11.1 per million doses administered, compared with 1.3 cases of anaphylaxis per million doses of influenza vaccine administered, officials said.

“We know that safety is one of the public’s biggest concerns about the Covid vaccine,” said Dr. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention.

“The anaphylaxis rate may seem high compared to the flu vaccine, but I want to reassure you: This is still a rare outcome.”

Any site that administers the vaccine must be prepared to recognize and treat a severe allergic reaction that may occur, federal health officials said. And though there is less information about reactions to the Moderna vaccine than to the Pfizer-BioNTech vaccine, Dr. Messonnier said, “At this point we really don’t have enough data to say there’s any difference in the risks, so the recommendations apply to both.” Recipients who experience anaphylaxis after receiving the first dose of the vaccine should not receive the second dose, officials said.

Other than the anaphylaxis reactions, which occurred shortly after vaccination, “Our vaccine safety systems haven’t picked up any worrisome signals,” Dr. Messonnier added. “The known and potential benefits of the Covid vaccine outweigh the risk of getting Covid-19.”

The C.D.C.’s analysis of adverse reactions, published on Wednesday, included only those to the Pfizer-BioNTech vaccine administered between Dec. 14 and Dec. 23.

[…]

The vast majority of anaphylaxis reactions — 90 percent — occurred in women, who made up slightly more than half of vaccine recipients. A surprising number of those who went into anaphylaxis — 14 of the 21 — had never experienced an anaphylactic reaction prior to receiving the vaccine, and four had no known allergies at all.

Of the 21 who had reactions, 20 had recovered or been discharged home, and information was lacking on one individual. Nineteen were treated with epinephrine, and four were hospitalized, including three in intensive care. Seventeen were treated in an emergency department.

The C.D.C. said it was still investigating another seven reports of anaphylaxis following the vaccine, which have not been confirmed. The Vaccine Adverse Event Reporting System also identified 83 cases of nonanaphylaxis allergic reactions after the Pfizer-BioNtech vaccination; these people developed symptoms like rash and mild respiratory symptoms within a day of receiving the vaccine.

Among the 21 vaccine recipients who experienced anaphylaxis, 17 were known to have allergies to a variety of triggers, including foods, insects, pets and medications. The median time for anaphylactic reaction was 13 minutes after immunization, but one patient developed the reaction two and a half hours afterward.

Patients with known allergies have been warned to bring an epinephrine injector when they get vaccinated, and providers have been advised to keep patients with allergies for observation for 30 minutes following inoculation.

The new information is disconcerting, said Diana Zuckerman, president of the National Center for Health Research.

“The flaw in the system is that there was a small number of people who had a reaction 30 minutes or later,” she said. “It’s one thing to say everybody should hang around for 15 minutes. But the range was up to 150 minutes, and people aren’t going to hang around that long.”

To read entire article, see https://www.nytimes.com/live/2021/01/06/world/covid-19-coronavirus

Congressman calls for FDA to continue vaccine trials

In the News, News Stories & Editorials, We're In the News, , , , ,

D’Andre Henderson, ABC News: December 29, 2020.

WASHINGTON, D.C. (WRIC) — Americans are hopeful that the COVID-19 vaccines will make 2021 a better year than 2020. However, there are concerns that Pfizer and Moderna will stop their clinical trials and immediately treat everyone in their placebo group.

Some scientists, doctors and now a Congressman argues that can be dangerous because they said there is still so much unknown about the vaccines.

Rep. Llyod Doggett of Texas wrote a letter to the Food and Drug Administration (FDA) urging for the clinical trials to continue.

“the continuation of clinical trials is critical to our understanding of the efficacy and length of immunity the vaccines offer,” Doggett wrote.

In the letter, Doggett said while the initial results received from Pfizer and Moderna are showing positive results, it’s not definitive given the limited data.

[…]

“Clinical trials have suffered from a lack of diverse participant enrollment and evaluation of subpopulations,” Doggett said. “Including individuals with comorbidities, children, pregnant and breastfeeding patients, long-term care residents and individuals with diverse racial and ethnic backgrounds.”

Diana Zuckerman, President of the National Center for Health Research, a non-partisan think tank in Washington D.C., agrees that the clinical trials should continue. She said healthcare workers who volunteered for the clinical trials should have immediate access to the vaccine if they want it.

“Like most public health experts, I’ve been very concerned that Pfizer and Moderna told the FDA that they want to stop their clinical trials of the COVID vaccine and instead immediately inoculate everyone in their placebo groups,” Zuckerman said. “While I understand the desire to reward the clinical trial volunteers for their service, it would be a huge loss of information from a public health point of view. Losing the placebo group means we’d have no way to scientifically determine which of the vaccines – if any — have 95% efficacy rates that last more than 2 or 3 months. Or how long the vaccine works on people over 75.”

Zuckerman added the people who volunteer for the clinical trials shouldn’t be vaccinated before those in priority groups such as teachers, essential workers, etc.

“Since many of the study volunteers are young and healthy, it also seems unfair for them to “cut in line” for a vaccine while healthcare workers and others at high risk are still waiting their turn,” she said.

[…]

Read the full article here

Covid-19: Should vaccine trials be unblinded?

In the News, News Stories & Editorials, We're In the News, , , , ,

Jeanne Lenzer, BMJ: December 29, 2020.

The lack of planning for how to treat participants in covid-19 vaccine trials is a bad precedent, with the loss of potentially valuable safety and efficacy data, say research experts. Jeanne Lenzer reports:

 

In October the US Food and Drug Administration issued non-binding guidance to manufacturers of covid-19 vaccines urging them to devise a method to allow volunteers in their studies’ placebo arms to receive the vaccine while also maintaining the integrity of ongoing scientific data collection.1 Emergency use authorisation was not “grounds for stopping blinded follow-up,” said the agency.23

The companies say they have an ethical obligation to unblind volunteers so they can receive the vaccine. But some experts are concerned about a “disastrous” loss of critical information if volunteers on a trial’s placebo arm are unblinded.45

To try to tackle the problem the FDA invited Steven Goodman, associate dean of clinical and translational research at Stanford University, for a recommendation that could balance the right of volunteers to find out whether they were in the placebo arm and the simultaneous need to preserve scientific data.

Goodman recommended a study design endorsed by Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases: a blinded crossover study in which placebo recipients would be given the vaccine, and vice versa.235 That would ensure that all volunteers receive the vaccine but would be unaware of which shot they received at which time. This would allow ongoing surveillance of safety issues and more time to observe any waning effects of the vaccine and the possible need for booster doses.

But the companies said that the demands of a blinded crossover design were “onerous” and might not be feasible.6 And even before the FDA advisory committee meeting on Moderna’s vaccine on 17 December, the company notified volunteers that they could learn their status if they chose to receive the vaccine.

Pfizer also sent a letter to its trial participants one week after its vaccine was authorised on 10 December.7 It told them that, on request, they could learn whether they were in the placebo arm so they could receive the vaccine as it became available and according to recommendations of the US Centers for Disease Control and Prevention.

Asked by The BMJ whether the FDA had set any baseline requirements for the companies regarding the removal of blinding, the agency declined to answer, referring the journal to the respective companies for their plans.

Pfizer told The BMJ that the “move from the placebo group to the vaccine group would be completely optional, and participants would be encouraged to remain blinded throughout the full study duration.” Moderna failed to respond to several requests for comment.

Loss of data

Diana Zuckerman, president of the National Center for Health Research, told The BMJ that the FDA could have demanded that companies use the blinded crossover design for them to win full approval for their vaccines. She said that failure to do that meant the loss of future reliable data, which is especially concerning given that preliminary data are insufficient to determine efficacy.

“I’m especially concerned that Pfizer’s vaccine trials included only five people aged 75 and older who were diagnosed with covid-19, with an unspecified number of those defined by Pfizer as severe cases,” she said. “That makes it impossible to determine how effective the vaccine is for frail elderly patients.”

Although the FDA has granted the vaccines emergency use authorisation, to get full licence approval two years of follow-up data are needed. The data are now likely to be scanty and less reliable given that the trials are effectively being unblinded.

Consumer representative Sheldon Toubman, a lawyer and FDA advisory panel member, said that Pfizer and BioNTech had not proved that their vaccine prevents severe covid-19. “The FDA says all we can do is suggest protection from severe covid disease; we need to know that it does that,” he said.

He countered claims, based on experience with other vaccines, six weeks of follow-up was long enough to detect safety signals. Six weeks may not be long enough for this entirely new type of “untested” [mRNA] vaccine, Toubman said.

Goodman wants all companies to be held to the same standard and says they should not be allowed to make up their own rules about unblinding. He told The BMJ that, while he was “very optimistic” about the vaccines, “blowing up the trials” by allowing unblinding “will set a de facto standard for all vaccine trials to come.” And that, he said, “is dangerous.”

Footnotes

  • Correction: On 30 December we amended the final paragraph to clarify Steven Goodman’s comment.

This article is made freely available for use in accordance with BMJ’s website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.

https://bmj.com/coronavirus/usage

References

  1. ↵ Food and Drug Administration. Emergency use authorization for vaccines to prevent covid-19: guidance for industry. 2020. https://www.fda.gov/media/142749/download.
  2. ↵ Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee meeting December 10, 2020. 2020. https://www.fda.gov/media/144245/download.
  3. ↵ Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee December 17, 2020 meeting briefing document. 2020 https://www.fda.gov/media/144434/download.
  4. ↵ WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation. Placebo-controlled trials of covid-19 vaccines—why we still need them. N Engl J Med2020. doi:10.1056/NEJMp2033538.
  5. ↵ Weiland CZ. Noah. Many trial volunteers got placebo vaccines. Do they now deserve the real ones? New York Times. 2 Dec 2020. https://www.nytimes.com/2020/12/02/health/covid-vaccine-placebo-group.html.
  6. ↵ Karlin-Smith S. Covid-19 vaccine sponsors want US FDA to find alternatives for control-arm data after first EUA. Pink Sheet. 2020. https://pink.pharmaintelligence.informa.com/PS143143/COVID-19-Vaccine-Sponsors-Want-US-FDA-To-Find-Alternatives-For-Control-Arm-Data-After-First-EUA.
  7. ↵ Tanne JH. Covid-19: FDA panel votes to approve Pfizer BioNTech vaccine. BMJ2020;371:m4799.  doi:10.1136/bmj.m4799 pmid:33310748 FREE Full TextGoogle Scholar 

Read the full article here

How Effective Is the Mask You’re Wearing? You May Know Soon

News Stories & Editorials, We're In the News,

A CDC division is working with an industry standards group to develop filtration standards — and products that meet them will be able to carry labels saying so.

Sheila Kaplan, The New York Times: December 16, 2020

More than 100,000 varieties of face masks are currently for sale. They come in silk, cotton and synthetics; with filters and without; over-the-head and over-the-ears. They have sparkles and sunflowers; friendly greetings and insults; cartoon characters and teeny reindeer.

What they don’t have is a label that shows how well they block infectious particles, an omission that has frustrated public health officials during the coronavirus pandemic. Those experts note that there is a big range in the effectiveness of various designs, and some barely filter out particles at all.

“The most fundamental, basic question is, What is the safest mask and how do I assure that I have that, and my family members and children have that?” said Fran Phillips, who stepped down in August from her post as deputy health secretary of Maryland. “It’s so startling that we are here in this moment and we don’t have that information.”

That may change soon. A division of the Centers for Disease Control and Prevention is working to develop minimum filter efficiency standards, and labels showing which products meet them, for the vast and bewildering marketplace for masks and other face coverings.

The National Institute for Occupational Safety and Health, a division of the C.D.C. known as NIOSH, has been quietly writing guidelines with an industry standard-setting organization, ASTM International (formerly the American Society for Testing and Materials), that are expected to be made public next month.

“By having a standard in place you will be able to know what level of protection is being achieved and you’ll have a consistent way of evaluating these products,” said Maryann D’Alessandro, director of the NIOSH National Personal Protective Technology Laboratory.

Since the pandemic began, there has been little federal oversight of masks and other face coverings. Both the Food and Drug Administration and the C.D.C. have some authority over the industry. The F.D.A., which regulates medical devices, shares authority with NIOSH for oversight of N95 respirators, which are the most protective devices available. But most of the masks the general public wears are just pieces of cloth and don’t come under any regulatory oversight.

Sales of masks took off after the F.D.A. issued an emergency measure in April that said in part that the agency would not take action against companies selling them to the general public. At the same time, however, the F.D.A. also noted that these products “may or may not meet fluid barrier or filtration efficiency levels.” That warning didn’t hurt the market, and some critics now blame the F.D.A. for the poor quality of many of the products being sold.

“There were many things the F.D.A. could have done to improve the situation, especially after research started coming out about which masks worked and which didn’t,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit health policy group. “F.D.A. could have issued a guidance that masks should be fitted, at least two layers of cloth, not made of stretchy materials, etc. Instead, there was a free-for-all.”

The effectiveness of masks can range “from 0 to 80 percent, depending on material composition, number of layers and layering bonding,” said Dale Pfriem, president of Protective Equipment Consulting Services and a member of the standards development working group addressing mask guidelines.

[…]

Read the full article here https://www.nytimes.com/2020/12/16/health/covid-masks-effectiveness.html

FDA Panel Reviewing Pfizer Vaccine Leaves Out Some Experts Who Raised Concerns

News Stories & Editorials, Uncategorized, We're In the News, , , , , , , ,

David Hilzenrath, Project on Government Oversight: December 9, 2020.

When an FDA advisory committee meets tomorrow to review Pfizer’s coronavirus vaccine, the lineup of committee members will look different from the group that met in October to begin the committee’s discussion of coronavirus vaccines.

Four people who participated in the earlier meeting as temporary committee members, including experts who raised questions and expressed concerns about the testing process, do not appear on the “draft roster” of panelists the FDA has posted for tomorrow’s meeting.

Meanwhile, there will be new faces. The FDA has added 10 temporary committee members who did not participate in the earlier meeting.

The changes in the lineup raise concerns, Diana Zuckerman, president of the National Center for Health Research, said in answer to questions from the Project On Government Oversight (POGO).

Zuckerman said experts might have been excluded to avoid tough questions about Pfizer’s data.

“It is not unusual for temporary members of FDA Advisory Committees to change, but seems surprising since the issues they are considering at the Oct meeting and tomorrow are so similar,” Zuckerman said by email.

Zuckerman’s organization analyzes the safety and effectiveness of pharmaceuticals and other medical products.

POGO asked the FDA whether the disappearance of some people from the advisory committee lineup had anything to do with any questions, concerns, or opinions they have expressed. In response, an FDA spokesperson did not directly answer.

The FDA routinely supplements advisory committees with temporary voting members, including “scientists or medical personnel whose expertise may not be represented by the fixed voting membership,” the FDA spokesperson said by email. “Many times, committees need to invite experts who are unrelated to the knowledge and expertise spelled out in the committee charter if a medical product or topic for discussion calls for a specific need for a particular expert,” the spokesperson added.

That does not seem to explain why the FDA would drop temporary voting members it selected to participate in the October meeting. At that meeting, without evaluating any particular vaccine, the committee advised the FDA on how in general it should approach experimental coronavirus vaccines.

Dr. Luigi Notarangelo, an expert on clinical immunology at the National Institute of Allergy and Infectious Diseases, was not invited to participate in the December 10 FDA advisory committee meeting on Pfizer’s coronavirus vaccine. He served as a temporary committee member when the panel met in October and minced no words then as he expressed general concerns about the testing of coronavirus vaccines.

[….]

POGO recapped his commentary at the October meeting in a November 2 story, “FDA Whitewashes Warnings About Coronavirus Vaccine Trials.”

As POGO reported:

Dr. Luigi Notarangelo, a committee member who is a chief researcher at the National Institutes of Health, minced no words as he articulated several of the critiques.

Notarangelo said measures of vaccine effectiveness included in an FDA document the committee was asked to review have two problems.
“First of all, they really are biased—skewed towards mild disease,” he said. “Mild disease may not mean very much.”
“The other problem with those efficacy measures is that most of them are really subjective,” he said. “And I think that’s a major concern. I mean, we’re relying basically upon reporting from the subjects without any objective validation of what they’re reporting.”

At the time, Notarangelo was not commenting specifically on Pfizer’s data.

Another person who served as a temporary member on October 22 but does not appear on the roster for tomorrow is Kathryn Holmes, a professor emerita in the Department of Immunology & Microbiology at the University of Colorado School of Medicine.

“One of the things I have not heard much about during this conversation is infection,” Holmes said at the October meeting. “I’d like to see how we could actually be measuring infection rather than just mild disease. … We should be looking to see what can prevent infection because that is the rubric which would prevent spread through the community most effectively and that is what would protect our elderly as well.”

Holmes could not be reached for comment for this story.

Another person who participated in the October meeting but is not slated to participate tomorrow is Dr. Michael Nelson, president of the American Board of Allergy and Immunology and a physician at Walter Reed Army National Military Medical Center.

At the October meeting, Nelson said “more real-time data might be needed.”

Nelson also noted that, when the acting chair of the committee summarized members’ comments, he omitted “a lot of concern” about an aspect of how vaccine effectiveness was being measured—whether it was focused inordinately on preventing milder cases.

Read the full article here

Four ways Trump has meddled in pandemic science — and why it matters

In the News, News Stories & Editorials, We're In the News, , , , , , , , ,

Giuliana Viglione, Nature: November 3, 2020

As the United States votes today on who will be its next president, Donald Trump’s response to the COVID-19 pandemic looms large. One issue that resonates with the research community is the extent to which the current president and his administration have meddled with science and scientific advice during the pandemic — often with disastrous results.

Last month, a coronavirus-crisis sub-committee within the US House of Representatives released a report documenting 47 instances in which government scientists had been sidelined or their recommendations altered. And the report notes that the frequency of meddling has been increasing in the lead-up to the US election.

“It’s hard to express how unbelievably demoralizing this experience has been,” says Diana Zuckerman, president of the National Center for Health Research, a non-profit organization in Washington DC.

If Trump wins a second term, researchers fear what that could mean for public health and the scientific enterprise. If Democratic challenger and former vice-president Joe Biden wins, he’ll have his work cut out for him to restore the reputation of the US science agencies that Trump has damaged.

Nature chronicles some of the most significant cases of meddling so far, and assesses their impact.

Scientists sidelined, silenced and ignored

At a campaign rally this week, Trump suggested that if he were re-elected, he would fire much-revered and long-standing infectious-disease expert Anthony Fauci, who has led the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), since 1984. Fauci has earned international acclaim as an adviser on HIV/AIDS to six US presidents, and is one of the most-cited researchers in the world.

This display follows a pattern of Trump attempting to silence and discredit Fauci throughout the pandemic: in May, in an unprecedented move, the administration blocked Fauci from testifying about the US pandemic response in front of the Democrat-led House of Representatives’ appropriations committee. “Never in my 30-plus years here in Washington do I recall ever a White House refusing to let an NIH expert testify before Congress,” says Zuckerman. The White House did not respond to Nature’s request for comment.

From cruise ships to asymptomatic spread: expert advice ignored

[….]

 

But Trump’s treatment of Fauci is just one example of the administration’s willingness to sideline its world-famous experts and institutions. The Centers for Disease Control and Prevention (CDC) is a world-renowned health agency and typically plays a major role in tracking and responding to outbreaks. In previous crises, its scientists have issued advice and updates directly to the public through regular media briefings. But compared with previous global-health crises, experts at the CDC have been unusually quiet during the COVID-19 pandemic, according to an analysis by the Union of Concerned Scientists (UCS) that was issued in May.

The report found that during the current pandemic, the CDC has held a much smaller proportion of press events than usual. For instance, during the H1N1 pandemic in 2009, the CDC led all but 3 of the 35 press conferences in the first 13 weeks of the pandemic. In contrast, Trump led close to three-quarters of the 69 press events during the same period of the COVID-19 outbreak. CNN reported that the lack of press briefings by the CDC on the coronavirus was due to pressure from the White House. “It is concerning that the scientists that are doing this great work are unable to talk,” says Anita Desikan, a research analyst at the UCS’s Center for Science and Democracy. The CDC did not respond to Nature’s request for comment.

[….]

In August, now-removed guidance appeared on the CDC’s website that stated that asymptomatic people no longer needed to be tested for the virus, counter to the recommendations of public-health experts. A senior CDC official told CNN that this guidance was issued “from the top down”; it was eventually reversed after public outcry. Officials outside the CDC have allegedly inserted their own documents on the CDC website in a move that Samuel Groseclose, a retired epidemiologist who spent 27 years at the agency, calls “bizarre”.

Revered public-health report delayed

The Trump administration has also attempted to meddle with a mainstay of the American public-health community: a weekly, peer-reviewed report that’s meant to facilitate the rapid release of epidemiological data. In September, Politico reported that political appointees in the Department of Health and Human Services, which oversees the CDC, had attempted to delay or halt the release of and retroactively edit the CDC’s Morbidity and Mortality Weekly Report (MMWR). Officials also demanded oversight before some results were published. The MMWR is “revered in the public-health community”, says Liz Borkowski, a public-health researcher at George Washington University in Washington DC, adding that she was “utterly horrified” to hear of the attempted meddling.

[….]

COVID treatments prematurely approved

Convalescent plasma, antibody-laden blood plasma from someone who survived COVID-19, was a promising treatment early in the pandemic. In August, the Trump administration leaned heavily on Food and Drug Administration (FDA) commissioner Stephen Hahn to issue an Emergency Use Authorization (EUA) for the treatment despite a lack of solid evidence that it helps people, as reported by The New York Times and The Washington Post. The FDA issued the EUA, making plasma available to a wide swath of the US population. But evidence from a clinical trial in India1, posted in September, suggests that the treatment has no effect on patient outcomes. Earlier in the pandemic, the agency had to revoke its authorization of hydroxychloroquine, which Trump had touted as a “game changer” for COVID-19, because it, too, was subsequently shown to be ineffectual at treating the disease.

[….]

To many public-health experts, it is clear that the Trump administration’s persistent meddling is responsible for the disastrous way in which the pandemic has unfolded in the United States. “Some of it is probably real and some of it is probably supposition,” Georges Benjamin, the executive director of the American Public Health Association in Washington DC, says of the media reports about interference. “But at the end of the day, this has been one of the worst risk-communications processes that I’ve ever seen. And I think that’s tragic.”

doi: https://doi.org/10.1038/d41586-020-03035-4

References

  1. 1.

Agarwal, A. et al. Preprint at medRxiv https://doi.org/10.1101/2020.09.03.20187252 (2020).

Read the full article here.