Tag Archives: coronavirus

FDA Panel To Lay Regulatory Groundwork For COVID-19 Vaccine


Noel King and Sydney Lupkin, NPR: October 22, 2020


NOEL KING, HOST:

There are several COVID-19 vaccines in development. But before they are approved, they have to be safe. It’s the FDA’s job to ensure that. Today an FDA advisory panel is meeting for the first time about the coronavirus vaccine. It’ll be making recommendations based not on politically motivated timetables, but on data.

Sydney Lupkin covers the pharmaceutical industry for NPR. Good morning, Sydney.

SYDNEY LUPKIN, BYLINE: Good morning.

KING: So what is the deal with this FDA panel? Who’s on it? What are they going to be doing?

LUPKIN: Well, the FDA regularly turns to committees of outside advisers for guidance. Most often, these panels are asked to evaluate specific drugs or health products, and that helps the agency to decide whether to approve these products. Today’s meeting of the committee that looks at vaccines is going to be a little different.

KING: How?

LUPKIN: Like everything else in this pandemic, it’s a bit unusual. The big difference is that the committee isn’t going to be sifting through data for a specific coronavirus vaccine like it normally would. The meeting will be a broader discussion of how the agency should think about safety and effectiveness of these new kinds of vaccines, particularly safety. Dr. Paul Offit is a committee member who works at the Children’s Hospital of Philadelphia.

PAUL OFFIT: How robust should safety data be? How long, for example, after the first or second dose should patients be followed or participants be followed for any possible safety issue?

LUPKIN: They’ll be discussing FDA’s existing guidance to companies, which includes some of that information. They’ll also discuss how studies should continue after the first vaccine is given the green light. What do you do for patients who got a placebo once a vaccine is widely available? Of course, the FDA usually heeds the advice of these committees, but it doesn’t have to.

KING: So since there’s no vaccine to review, I would think that in ordinary times, we would not know about this meeting. It would not be news at all. It’s very clear that the FDA wants to make public that this is happening. Why do they want to do that?

LUPKIN: Well, I mean, it gives the American public a window into the process. There’s been so much discussion around whether the FDA will put politics ahead of science. So it’s important to see what’s going on. And the FDA has questions that it wants answers to. Here’s Dr. Miles Braun, a former FDA epidemiologist.

MILES BRAUN: There is a level of humility that the FDA is coming to its advisers with. And I think that’s a good thing. And if they find out they’ve missed some important things, they’ll address those.

LUPKIN: Committee members will hear presentations from scientists at the FDA, the Centers for Disease Control and Prevention and the Biomedical Advanced Research and Development Authority. The public will also have an opportunity to weigh in. Diana Zuckerman is the president of the National Center for Health Research, an advocacy group slated to speak.

DIANA ZUCKERMAN: We’ve seen the guidance of what they’re telling companies they’re supposed to be studying. Frankly, they’re not very stringent, so we are concerned about them.

LUPKIN: She hopes the meeting will delve into making sure the clinical trials are diverse, for example. She also questions whether the study approach the FDA suggested to manufacturers is long enough to assess vaccine safety.

[…]

Read or listen to the full article here

CRS: Congress Can Rein in FDA’s Flexible Covid-19 Vaccine Trial Policies

Beth Wang, Inside Health Policy: June 03, 2020


The Congressional Research Service says Congress could rein in FDA’s broad discretionary authority over vaccine clinical trial policies by legislating how the agency and Institutional Review Boards approach clinical trial designs and reviews for the current COVID-19 pandemic, as well as for future emergencies. In a Tuesday (June 2) report, CRS suggests Congress could provide more specific direction to FDA and IRBs on how to approach clinical trials in emergency situations, and also could appoint a neutral scientific body to consider ethical and scientific issues as well as general guidelines for trials. Congress also could fund global collaboration among regulators, and provide additional funding and resources to facilitate clinical trials, the report suggests, echoing recent calls from lawmakers who have said the United States should get involved with global efforts to fund and develop COVID-19 vaccines and treatments.

Diana Zuckerman, president of the National Center for Health Research, applauded CRS for explaining the vaccine approval process to Congress and for telling lawmakers what their options are so Congress can, in Zuckerman’s words, “ensure a better outcome than we’ve seen with the disastrous coronavirus testing situation (in terms of accuracy, transparency, and availability).” The document, she told Inside Health Policy, does a good job of explaining that FDA has authority to lower approval standards for any drug or vaccine unless Congress steps in. “[B]ased on FDA’s actions of the last 3 months, it seems likely that they will do so in ways that could create the free-for-all that currently exists for coronavirus testing,” Zuckerman wrote in an email. “So the CRS is telling Congress that legislation is the option they have if they want to ensure a better outcome.”

Existing law, CRS says, requires FDA and IRBs to weigh considerations about safety and effectiveness against the desire to bring products to market quickly when evaluating proposed clinical trial designs for vaccines.

[…]

Congress previously told FDA what to do in the drug trial and approval space through passage of the 21st Century Cures Act, but FDA was given leeway in how to interpret the law, Zuckerman explained. “It pushed FDA in a particular direction but still gave the FDA the authority to rely on the agency’s subjective judgment,” she said. If Congress were to step in and tell FDA what it should do, it would be a radical departure, Zuckerman added. “[But it’s] probably necessary given FDA’s response to the pandemic so far, and the Administration’s track record of ignoring Congress when it suits them,” she said.

Read the entire article here.

Tests for COVID-19: Has the FDA said yes too many times?

By Robert M. Kaplan and Diana Zuckerman, The Hill Opinion Contributors, May 6, 2020


There are many controversies about the coronavirus, but there is one point of consensus: We need testing, testing, and then more testing. But yesterday, in response to criticisms from chairs of two House health subcommittees, the FDA tightened their standards for antibody tests intended to identify people who were previously exposed to the coronavirus. Why?

Typically, the FDA approves tests based on evidence of accuracy. But, under the urgency of the pandemic, the FDA temporarily lifted the requirement that tests be validated before they are marketed. Until the new policy was announced, it was not clear when or if the FDA would review the accuracy of each test.

The FDA website shows that, to date, the FDA has temporarily approved coronavirus testing for 84 different labs and companies. There were 14 new approvals in the last week alone and more than 400 more applications are waiting for FDA’s review. Unfortunately, none of the tests currently available – not the 84 and not the other 400 — have a record of proven accuracy that can be independently verified.

[….]

What happens when hundreds of unvalidated tests flood the market? Monitoring a pandemic requires accurate, consistent information. With so many tests, we can’t know when cases are peaking, stabilizing, or decreasing in different communities — and therefore, when it is possible to loosen restrictions on social distancing.

Read the article here https://thehill.com/opinion/healthcare/496403-tests-for-covid-19-has-the-fda-said-yes-too-many-times

What People With Cancer or Compromised Immune Systems Need to Know about Coronavirus (COVID-19)

National Center for Health Research: Updated November 15th, 2022


The coronavirus can infect anyone, young or old, healthy or frail. People with cancer and other serious health conditions, and their loved ones, need to be especially careful. Here’s what you need to know.

Some cancer treatments, such as chemotherapy, targeted therapies, immunotherapy, and radiation, can weaken the immune system and possibly cause lung problems. People who have weakened immune systems or lung problems are more likely to have serious symptoms if they become infected with this virus. Anyone with cancer in the lungs (whether lung cancer or cancer that has spread to the lungs) is especially at risk if they develop COVID-19.

What is coronavirus?

Coronaviruses are a large group of viruses that can cause respiratory illness. The new (novel) coronavirus is called SARS-CoV-2 and the illness it causes is called coronavirus disease 2019, which is why it’s abbreviated as COVID-19.  Since it is new, nobody has immunity from it.

How does COVID-19 spread between people?

The virus usually spreads through close contact with other people, especially through droplets when a person coughs or sneezes – or even when they breathe normally. These droplets can travel through the air and can be inhaled or get into the noses, mouths, or eyes of people nearby.

It is most contagious when the person has symptoms, but it is possible to catch the virus from infected people who have no symptoms at all. In addition, these droplets (as well as fecal matter containing the virus) can end up on surfaces where it can survive for short periods of time.

Symptoms tend to start between 2 and 14 days after coming into contact with the virus. Although some people have compared the symptoms to a cold or flu, not everyone with COVID-19 has those types of symptoms. In fact, some people (especially children, teens, and younger adults) have very mild symptoms or none at all, which is why getting tested is so important before you spend time with others. These symptoms have been reported in people with COVID-19:

·       Fever or chills

·       Cough

·       Shortness of breath or difficulty breathing

·       Fatigue

·       Muscle pains

·       Headache

·       New loss of taste or smell

·       Sudden confusion (delirium)

·       Skin rash, redness on toes/fingers

·       Chest pains

·       Sore throat

·       Congestion or runny nose

·       Nausea or vomiting

·       Diarrhea

·       Skipping meals

·       Abdominal pains

·       Sneezing

·       Changes in the mouth or tongue

Studies out of the United Kingdom show that the most common symptom associated with COVID-19 is a sore throat, with fever and loss of smell becoming rarer in patients. Tim Spector, a professor of genetic epidemiology at King’s College London, reported that “COVID starts in two-thirds of people with a sore throat,” which is something to keep an eye out for if you think you may have COVID.

Most people who are infected with this coronavirus have mild symptoms and can recover at home in about 2 weeks. However, symptoms can become severe. These are the ones that require immediate medical attention:

  • Difficulty breathing or shortness of breath
  • Persistent chest pain or pressure
  • Confusion or inability to awaken
  • Blueish color in the lips or face

People who are older than 60 or with other medical conditions are more likely to develop severe illness and complications from COVID-19. The most serious complications include pneumonia, stroke, blood clots, organ failure, and death.

How can I protect myself and others?

If you live in the U.S., the best way to protect yourself and others it to get one of the 3 vaccines available. The vaccines are widely available throughout the U.S. in multiple locations from community health centers to local pharmacies. Treatment options for COVID-19 do not cure the virus but FDA has designated treatments can help prevent hospitalization and death. The FDA has approved one drug treatment for COVID-19 and granted emergency use authorizations (EUAs) for 12 drug treatments, two of which were later rescinded. However, several of the remaining 10 treatments are now rarely used. Details about available treatments are described here.

What if you are pregnant?  Research shows that COVID infection is dangerous to pregnant women and that vaccinating pregnant women is safe.  For example, a study of more than 24,000 newborns, of whom almost 17,000 were exposed to a mRNA COVID vaccine in the first or second trimesters when their mothers were vaccinated, found no differences in preterm birth rates, neonatal hospitalizations, congenital abnormalities or infant mortality.  A small study found that most infants born to COVID-vaccinated mothers had persistent antibodies at 6 months, compared with infants born to mothers who had been infected with SARS-CoV-2.

In contrast to vaccination, a COVID infection increases the chances of serious harm for pregnant women.  A retrospective study of more than 14,000 pregnant women found that those with COVID infections were more likely to die or have serious illness related to hypertensive disorders of pregnancy, postpartum hemorrhage, or infection other than SARS-CoV-2 compared to pregnant women who did not have a COVID infection (13% vs 9%).  All 5 maternal deaths in the study were women who were infected with COVID.

What should I do if I develop symptoms?

If you develop more than one of the symptoms listed above, get tested for COVID, using an at-home test. That’s the fastest way to get results, but keep in mind that the rapid tests (whether at home or anywhere else) are not as accurate as the PCR test. If you have symptoms but your rapid test is negative, test yourself again a day or 2 later, because the tests get more accurate after a few days of symptoms.

If you have symptoms that worry you, call your doctor whether or not you test positive. If you have severe symptoms, such as difficulty breathing, persistent chest pain or pressure, confusion or inability to awaken, or blueish color in the lips or face, you need to call 911. Tell the 911 operator that you think you have COVID-19 so the responders can take the necessary precautions to protect themselves.

People who experience mild symptoms can usually stay home and will recover in about 2 weeks. People are discouraged from simply showing up at the doctor’s office with symptoms: Call them first so you have tell them about your symptoms and any other health problems so that they can help decide what to do. If you do become sick, you can take the following steps to protect others:

  • Get tested for COVID-19, ideally with a PCR test to confirm the results (positive or negative) of your at-home test
  • Wear a face mask
  • Stay home, unless you need essential medical care
  • Stay away from others in your home as much as possible
  • Cover your mouth and nose when you cough or sneeze, properly dispose of tissues, and wash your hands
  • Monitor your symptoms and temperature

If you were not tested for COVID-19, you should follow those steps until at least one or two weeks have passed since you first noticed symptoms or your fever or other symptoms go away for 3 full days without medicine. If you have been diagnosed with COVID-19 based on test results, you should follow those same steps until you have 2 negative test results taken 24-hours apart, and your symptoms improve.

What if my cancer treatment is delayed?

When a person is diagnosed with cancer, they are likely to want treatment as soon as possible.  Treatment or testing may seem more urgent than it really is, especially with cancers that often grow slowly, such as prostate cancer or breast cancer. And, if you don’t have COVID-19, you don’t want to be exposed to it during cancer surgery, testing, or follow-up appointments.  Talk to your doctor about what is the best strategy to get the treatment you need when it is safe to do so.

Questions?

We are here to help by answering your questions.  We do not provide medical care.  If you have questions contact info@center4research.org and we’ll get back to you as soon as possible.