Q: Products Online Claim To Prevent Or Treat Covid
A: The FDA advises consumers to be beware of websites and stores selling products that claim to prevent, treat, or cure COVID-19. If you have a question about a product sold online that claims to treat, prevent, or cure COVID-19, talk to your health care provider or doctor.
Please report websites selling products with fraudulent claims about treatment or prevention of COVID-19. If you have experienced a bad reaction to a product sold with COVID-19 claims, report it to the FDAs MedWatch Adverse Event Reporting program:
- Complete and submit the report online or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
Include as much information as you can about the product that caused the reaction, including the product name, the manufacturer, and the lot number .
Q: Are There Any Approved Products That Can Prevent Or Treat Covid
A: No. Under the Federal Food, Drug, and Cosmetic Act, articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals are drugs. The FDA has not approved any drugs for the diagnosis, cure, mitigation, treatment, or prevention of COVID-19 in animals. The U.S. Department of Agricultures Animal and Plant Health Inspection Service Center for Veterinary Biologics regulates veterinary biologics, including vaccines, diagnostic kits, and other products of biological origin. Similarly, APHIS CVB has not licensed any products to treat or prevent COVID-19 in animals.
The FDA has taken action against unapproved products claiming to prevent or cure COVID-19. The public can help safeguard human and animal health by reporting any products claiming to do so to or 1-888-INFO-FDA .
Q: Are Antibiotics Effective In Preventing Or Treating Covid
A: No. Antibiotics do not work against viruses they only work on bacterial infections. Antibiotics do not prevent or treat COVID-19, because COVID-19 is caused by a virus, not bacteria. Some patients with COVID-19 may also develop a bacterial infection, such as pneumonia. In that case, a health care professional may treat the bacterial infection with an antibiotic.
Don’t Miss: Cost Of Cvs Covid Test
Novavax Vaccine Waiting For Fda Authorization
Another COVID-19 vaccine candidate, created by Novavax, is awaiting the FDA’s decision. Instead of an mRNA vaccine or a viral vector vaccine , .
The World Health Organization listed the Novavax vaccine for emergency use in December 2021. Since then, several countries have rolled out this vaccine, including Australia, Bangladesh, Canada, Great Britain, India, Indonesia, New Zealand, the Philippines and South Korea.
In the U.S., Novavax must be authorized for emergency use by the FDA before people can receive the shot. The FDA is currently reviewing the Novavax vaccine data.
What Is The Process For An Eua
The EUA process for a vaccine is similar to the BLA, or full approval, process in most ways. A manufacturer must conduct laboratory research, followed by animal testing, and submit an application. Phase I, II, and III clinical trials run as they normally would, as does the FDA assessment of manufacturing practices. But here are some notable steps that have a degree of overlap:
- Safety board: An independent data safety monitoring board evaluates data from the Phase III trial and tells the manufacturer whether or not they have met criteria for a clinical endpoint that had been pre-established by the FDA. Based on the groups findings, the manufacturer decides whether and when to submit an EUA request. The DSMBs are different than VRBPAC. Safety boards are established by the vaccine manufacturer as part of a trial and have access to unblinded trial data that they review while the trial is ongoing to see if there are any safety or efficacy signals that warrant action being taken before the trial is scheduled to conclude. DSMBs arent specific to the EUA or BLA pathways, but for the EUA COVID vaccines, it was their interim assessment that indicated the vaccines were highly effective and prompted submission to the FDAwhere VRBPAC then met and reviewed the formal submission.
Also Check: Cvs Pcr Test For Travel Cost
Pfizer Seeks Fda Approval For Three Covid Vaccine Doses For Children Below Five
Partners Pfizer, Inc and BioNTech SE urged the FDA to authorize three vaccine doses for children below five, the Wall Street Journal reports.
The companies previously asserted that three doses of the shot were 80% effective at preventing symptomatic Covid-19 with robust immune response in children between six months to five years.
After mixed results in the children who received two doses, the companies studied three doses to determine the relative efficacy of an extra dose. The FDA also postponed its review to wait for additional testing.
The latest Pfizer-BioNTech study results were pending peer-review by independent experts or published in a medical journal.
The Food and Drug Administration also weighed a request from Moderna, Inc to authorize two doses of its vaccine for children below six.
The FDA has scheduled meetings of outside medical advisers on June 14-15 to discuss data and review the applications from Pfizer-BioNTech’s and Moderna’s vaccine trials in young children.
The FDA clearance could come before the end of June.
U.S.’s last remaining group of people, or the 19 million young children, would get access to the vaccine on clearance from the Centers for Disease Control and Prevention.
Price Action: PFE shares traded lower by 0.71% at $52 in the premarket on the last check Thursday.
See more from Benzinga
Q: Is Bamlanivimab A Monoclonal Antibody Fda
A: No. On April 16, 2021, the FDA revoked the emergency use authorization for bamlanivimab administered alone for the treatment of COVID-19. Based on the totality of scientific evidence available, the Agency concluded that the known and potential benefits of bamlanivimab administered alone no longer outweigh the known and potential risks for the product. Read more about this action.
Read Also: How Long Does The Cvs Rapid Test Take
Q: How Can I Prevent Covid
A: The best way to prevent illness is to avoid being exposed to the virus. The CDC recommends everyday preventive actions to help prevent the spread of respiratory diseases. They include:
- Wash your hands often with plain soap and water. The CDC recommends washing your hands often with soap and water for at least 20 seconds, especially after you have been in a public place, or after blowing your nose, coughing, or sneezing. If soap and water are not available, the CDC recommends using an alcohol-based hand sanitizer that contains at least 60 percent alcohol. Learn more about safely using hand sanitizer.
- Cover your mouth and nose with a cloth face covering or non-surgical mask when around others. Find more information about how to select, wear, and clean your mask.
- Get the COVID-19 vaccinewhen it is offered to you. Once you are fully vaccinated, you may be able to start doing some things that you had stopped doing because of the pandemic.
I Misinformation From The Local Pharmacy
Misinformation on COVID-19 vaccines. Where does it come from?
On January 4, 2022, I informed my readers that there was no FDA-approved COVI-19 vaccine product available in the U.S. Shortly, after I posted that article, I recall reading that Modernas COVID-19 vaccine was approved. But I did not dig into the issue deeply to verify this news. It was approved supposedly. But was it available? Was it produced? Could it be ordered? Would it be distributed? If it was similar to past news that Pfizers COVID-19 vaccine was approved, then perhaps Modernas approved vaccine product also was not available for distribution in the U.S.
Yesterday, I was at the local Wal-Mart near the pharmacy so I thought Id do some exploration out of curiosity. Guess what? I struck a vein of misinformation gold.
A. Misinformation from Wal-Marts Pharmacy Technician
1. Moderna Paperwork
The Moderna paperwork packet she gave me included this page as page 2 of the packet:
The paperwork she gave me on the Moderna COVID-19 vaccine that they were ready, willing, and able to inject me with was for the EUA version, not an approved version. The sheet itself even says its unapproved. But I had to flip to the second page in the packet to find that information. And it says, There is no FDA-approved vaccine to prevent COVID-19.
2. Pfizer-BioNTech Paperwork Packet
B. The Wal-Mart Pharmacist
A. Availability of Modernas Approved Spikevax in the U.S.
Also Check: Hank Aaron Dies After Vaccine
Q: Should I Purchase Personal Protective Equipment Such As Facemasks Or N95 Respirators For Me And My Family
A: No. Surgical masks and N95s need to be reserved for use by health care workers, first responders, and other frontline workers whose jobs put them at much greater risk of acquiring COVID-19. The cloth face coverings recommended by CDC are not surgical masks or N95 respirators. Surgical masks and N95s are critical supplies that must continue to be reserved for health care workers and other medical first responders, as recommended by CDC.
Us Fda Flags Risk Of Heart Inflammation After Novavax Covid Vaccine
-The U.S. Food and Drug Administration has raised concerns about a possible risk of heart inflammation from Novavax Inc’s COVID-19 vaccine, even as the company’s data showed it could reduce the chances of mild-to-severe disease.
In Novavax’s nearly 30,000 patient trial, conducted between December 2020 and September 2021, there were four cases of a type of heart inflammation called myocarditis detected within 20 days of taking the protein-based shot.
“These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID-19 vaccines,” FDA staff wrote in briefing documents released on Friday.
The agency said it had requested Novavax to flag myocarditis and another kind of heart inflammation called pericarditis as an “important identified risk” in its materials. The company has not yet agreed to do so.
“Based on our interpretation of all the clinical data supporting NVX-CoV2373 … we believe there is insufficient evidence to establish a causal relationship,” the company said in a statement.
One patient in the trial reported myocarditis after receiving placebo.
“Despite the wide availability of authorized or approved vaccines, the SARS-CoV-2 pandemic is not well controlled in the U.S. … there remains a desire for vaccines that have been developed using well-understood technology platforms,” it said.
The FDA analyzed data from Novavax’s trial before the Omicron and Delta variant became the dominant strains.
Don’t Miss: Cost Of Rapid Test At Cvs
Timeline For Full Approval Of Covid
The FDA has not indicated when full approval of the mRNA vaccines might happen.
However, Pfizer and BioNTech as well as Moderna have already submitted applications for full approval of their vaccines officially known as a Biologic License Application to the FDA on May 7, 2021, and June 1, 2021, respectively.
These submissions started the clock on the FDAs regulatory review.
In the first 60 days, the agency checks the application to make sure its complete and decides which type of review will happen.
Tice said given the urgent need for the COVID-19 vaccines, the FDA will likely grant the applications priority review.
The agencys goal for this type of review is to make a decision within 6 months of submission.
That means the FDA would decide on full approval of the Pfizer-BioNTech vaccine by January 2022 and February 2022 for the Moderna vaccine.
This is the maximum review time frame. A decision could come sooner thanks to the work done for the EUAs.
The FDA has already reviewed the initial clinical trials data from both companies and the manufacturing aspects to grant the EUAs, said Tice, so full approval of these vaccines might happen in less than 6 months.
Q: Is The Monoclonal Antibody Actemra Approved For The Treatment Of Covid
A: No. Actemra is not approved as a treatment for COVID-19. However, the FDA issued an emergency use authorization for use of Actemra by healthcare providers for the treatment of COVID-19 in hospitalized adults and pediatric patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation .
Actemra is a monoclonal antibody that reduces inflammation by blocking the interleukin-6 receptor. In the case of COVID-19 infection, the immune system can become hyperactive, which may result in worsening of disease. Actemra does not directly target SARS-COV-2. Actemra is a prescription medication given by intravenous infusion that is FDA-approved for multiple inflammatory diseases, including rheumatoid arthritis.
Monoclonal antibody treatments for COVID-19 may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and have the ability to activate the emergency medical system , if necessary. Please speak with your doctor or contact your local or state public health department for more information.
Read Also: How Much Is Cvs Covid Testing
India Administers Over 175 Billion Vaccines Against Coronavirus So Far
The US Food and Drug Administration has approved a fifth Covid-19 booster shot of Pfizer-BioNTech or the Moderna for people aged over 50 and some immunocompromised individuals.
The FDA had previously authorised a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series. The new approval will now make a second booster dose of these vaccines available to other populations at higher risk for severe disease, hospitalisation and death.
The fifth booster can be administered to individuals 50 years of age and older at least 4 months after receipt of a fourth booster dose of any authorised or approved Covid vaccine.
Individuals 12 years of age and older with weaker immune systems such as those who have undergone solid organ transplantation are also eligible for the shots at least 4 months after receipt of a fifth booster dose.
The current vaccines were developed against the original virus that emerged in Wuhan, China in late 2019, and their effectiveness has declined over time as the virus mutates. The FDA stated that emerging evidence suggests that a fifth booster dose of an mRNA Covid-19 vaccine improves protection against severe Covid and is not associated with new safety concerns.
The Claim: The Food And Drug Administration Hasn’t Fully Approved Pfizer’s Coronavirus Vaccine
The Food and Drug Administration has given its official stamp of approval to Pfizer-BioNTech’s coronavirus vaccine. But online, a conspiracy theory doubting that fact has blossomed.
“DECEPTIVE MEDIA: Pfizer-BioNTech COVID-19 Vaccine NOT FULLY AUTHORIZED,” reads text in from a fan page for Candace Owens, a conservative commentator.
Similar posts parroting the claimhave accumulated thousands of interactions on Facebook and Instagram, according to CrowdTangle, a social media insights tool. The headline comes from a Substack newsletter published Aug. 24 by Mackenzie Alan Bettle and Hannah Griff.
“To the contrary of what was promulgated by all major media outlets yesterday, the Food & Drug Administration did not grant full approval to the Pfizer-BioNTech COVID-19 vaccine,” the conservative writers wrote. “We repeat, the FDA did not grant full approval to any vaccine.”
That claim gained traction on 4chan and other anonymous messaging boards before spreading to mainstream platforms, according to First Draft, a nonprofit that tracks online misinformation. The conspiracy theory has also been floated on a talk show hosted by Steve Bannon former chief political strategist in the Trump White House on conservative websites like the Gateway Pundit and seen tens of thousands of times.
But the claim is bunk. While Pfizer’s coronavirus vaccine is still only available to some groups under an emergency use authorization, the FDA has fully approved the shot for most Americans.
Recommended Reading: How Much Is A Pcr Test At Cvs
Q: What Is The Fdas Role In Helping To Ensure The Safety Of The Human And Animal Food Supply
A: To protect public health, the FDA monitors domestic firms and the foods that they produce. The FDA also monitors imported products and foreign firms exporting to the United States. The FDA protects consumers from unsafe foods through research and methods development inspection and sampling and regulatory and legal action.
Q: What Should I Do If I Think My Pet Has The Virus That Causes Covid
Pets infected with this virus may or may not get ill. Of the pets that have gotten sick, most only had mild illness and fully recovered. Serious illness in pets appears to be extremely rare.
Pets that do have symptoms usually have mild illness that can be taken care of at home. If you think your pet is sick with the virus or if you have concerns about your pets health, talk to your veterinarian. Most pets that have gotten sick from the virus that causes COVID-19 were infected after close contact with a person with COVID-19.
If your pet is sick and you think it might be from the virus that causes COVID-19, talk to your veterinarian.
If you are sick with COVID-19 and your pet becomes sick, do not take your pet to the veterinary clinic yourself. Call your veterinarian and let them know you have been sick with COVID-19. Some veterinarians may offer telemedicine consultations or other plans for seeing sick pets. Your veterinarian can evaluate your pet and determine the next steps for your pets treatment and care.
Recommended Reading: Cvs Covid Test Cost Without Insurance
Has The Fda Approved Any Covid
The Food and Drug Administration approved the first Covid vaccine â from Pfizer-BioNTech â this summer. This means the vaccine received the standard Biologic License Application approval, which represents the FDAs highest standard and requires a longer period of evaluation.
The FDA had previously granted Emergency Use Authorization to the Pfizer-BioNTech vaccine, the Moderna vaccine, and the Johnson & Johnson vaccine. Additional vaccines are in Phase 3 of clinical trials and maybe submitting data for review with the FDA soon.
Emergency Use Authorization exists to allow the FDA more flexibility to review and authorize products for use during public health emergencies, like a pandemic. In order to grant an EUA, the FDA must determine that a vaccine can effectively prevent infection or disease and that its benefits outweigh potential risks . While the EUA allows people to start receiving the vaccine, vaccine developers will continue to submit data to the FDA to achieve full FDA approval through a BLA.