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DPH Update On FDA Approval of Pfizer Vaccine

On Monday, August 23, 2021, the U.S. Food & Drug Administration (FDA) announced that it has approved the COVID-19 Pfizer-BioNTech vaccine biologics license application (BLA) for individuals 16+. It is the first of the three available COVID-19 vaccines to receive official approval from the FDA. Previously, the vaccine was being distributed only under an Emergency Use Authorization (EUA). There is not yet enough data to include 12-to-15-year-olds, or those immunocompromised persons eligible for a third dose under the full BLA approval, so the original EUA remains in place. We are providing a more detailed explanation of what this means and other changes included in the BLA.

The BLA approval for Pfizer includes a name change for the vaccine to COMIRNATY. The formulation of the vaccine is the same; only the name has changed.  Because of the current supply of Pfizer in the marketplace, you will see both names co-circulating. The EUA has been updated to permit administration of vaccine labeled COMIRNATY to persons 12-15 and who are immunocompromised and eligible for the third dose. Vaccines labeled COMIRNATY may be used interchangeably with Pfizer to complete a vaccine series or offer a third dose. There is no need to re-start a vaccine series begun with Pfizer if COMIRNATY is the only vaccine available to you. Additionally, there is no need to re-start the vaccine series if a patient did not receive their second dose of any mRNA vaccine within the recommended time frame.

 

Difference between Emergency Use Authorization and Full Approval

Given the impact of the COVID-19 pandemic, an EUA allowed the use of COVID-19 vaccines to prevent serious or life-threatening disease when certain criteria were met. The benefits of the COVID-19 vaccine compared to the risks warranted the EUA status. Full BLA approval of the vaccine means that FDA staff scientists had additional time to conduct an independent review, which included reviewing an additional eight months of safety and trial data, additional time to follow those involved in clinical trials and early vaccine administration, and visits to manufacturing sites.

What this means:

  • The Pfizer vaccine has been subject to an exhaustive independent review by FDA scientists – including an additional eight months of safety data and follow up with vaccine recipients.
  • Individuals worried about receiving a vaccine that has been approved for emergency use only can now seek the Pfizer vaccine.
  • While there is not yet enough data to include 12-to-15-year-olds or the immunocompromised who want a third dose under the full approval, this does not mean the vaccine is not safe for these individuals. They are still eligible for the Pfizer vaccine under the existing EUA.
  • The vaccine formula for Pfizer and COMIRNATY are the same, it just has a different name.  So you don’t need to restart the vaccine series if you got Pfizer for your first dose.  They can be used interchangeably since they are the same vaccine.

 

See additional resources:

DPH Statement On Third Dose of COVID-19 Vaccines

On August 13, after the U.S. Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the administration of an additional dose in certain immunocompromised individuals, the CDC endorsed that recommendation.

Providers may administer a third dose of either the Pfizer or Moderna vaccines to individuals in the following categories who received either vaccine the first time:

  • recipients of organ or stem cell transplants
  • people with advance or untreated HIV infection
  • active recipients of treatment for cancer
  • people who are taking some medications that weaken the immune system

The third dose may only be administered at least four weeks (28 days) after completing the original two-dose vaccine series. People who meet any of these categories are encouraged to contact their primary care or specialty care provider with questions or for a vaccine. If your provider is not administering vaccines, you may got to any pharmacy, or DPH Vaccination clinic for a third dose.  While you do not need to provide written proof of your condition, you must self-attest that you meet the conditions.  Visit de.gov/getmyvaccine for a list of vaccination sites.

This guidance does not apply to immunocompromised persons who received the J&J vaccines as the FDA and CDC did not have adequate data to make the same recommendation. For more information, visit  https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html

Myocarditis and Pericarditis

Myocarditis and pericarditis, which are extremely rare heart conditions that usually results from a viral infection, such as the flu, Lyme disease, and also COVID-19 disease.

Myocarditis is inflammation of the heart muscle, and pericarditis is inflammation of the outer lining of the heart. In both cases, the body’s immune system causes inflammation in response to an infection or some other trigger.

To date, a small number of cases have been confirmed in the United States in adolescents and young adults after receiving the mRNA vaccine by either Moderna or Pfizer. The condition is rare, occurring after less than one percent of the more than 329 million doses of the vaccines which have been administered nationwide.

Most patients who received care responded well to medicine and rest and quickly felt better. Cases have been most common in males under 30 and are most likely to occur within one week after the second dose.

An independent panel of advisors to the CDC met in late June and while they agreed that a warning about the potential risk should be added to the Food and Drug Administration’s (FDA) official fact sheets on the vaccines, they stated the benefits of the COVID-19 vaccination far outweigh the risks of heart inflammation in young people.

In a joint statement co-signed by some of the country’s leading health organizations, including the U.S. Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC), American Academy of Family Physicians (AAFP), American Academy of Pediatrics (AAP), American College of Physicians (ACP), and American Heart Association, the group stated:

“The facts are clear: this is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination. Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment. In addition, we know that myocarditis and pericarditis are much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe. We strongly encourage everyone age 12 and older who are eligible to receive the vaccine under Emergency Use Authorization to get vaccinated, as the benefits of vaccination far outweigh any harm.”

Read the full statement here: https://www.hhs.gov/about/news/2021/06/23/statement-following-cdc-acip-meeting-nations-leading-doctors-nurses-public-health-leaders-benefits-vaccination.html

The FDA and CDC have confidence that the vaccines produced by Pfizer and Moderna are safe and effective in preventing COVID-19. Both agencies will remain vigilant in continuing to monitor this risk and ask providers to make parents and guardians aware of the symptoms of myocarditis.

Symptoms include:

  • Chest pain
  • Shortness of breath
  • Feelings of having a fast-beating, fluttering, or pounding heart

Seek medical care if you think you or your child have any of these symptoms within a week after COVID-19 vaccination.  Contact your health care provider if you have questions.

If you have any health problems after vaccination, report them to the Vaccine Adverse Event Reporting (VAERS): https://vaers.hhs.gov/reportevent.html

Read CDC information page here: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html.

Guillain-Barre Syndrome (GBS)

GBS is a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness, or in the most severe cases, paralysis. To date there have been 100 preliminary reports of GBS following vaccination with the Johnson & Johnson (Janssen) COVID-19 vaccine out of approximately 13 million administered doses. Of these reports, 95 of them were serious and required hospitalization. There was one reported death.

Each year in the United States, an estimated 3,000 to 6,000 people develop GBS. Most people fully recover from the disorder. GBS has also been observed at an increased rate associated with certain vaccines, including certain seasonal influenza vaccines and a vaccine to prevent shingles.

At this time there is insufficient data to establish a causal relationship between the Janssen vaccine and GBS.

Learn more about GBS and vaccines here.

Thrombocytopenia Syndrome (TTS)

After receiving the J&J/Janssen COVID-19 Vaccine, there is risk for a rare but serious adverse event—blood clots with low platelets (thrombosis with thrombocytopenia syndrome, or TTS). Women younger than 50 years old should especially be aware of their increased risk for this rare adverse event. There are other COVID-19 vaccines available for which this risk has not been seen.

This adverse event is rare, occurring at a rate of about 7 per 1 million vaccinated women between 18 and 49 years old. For women 50 years and older and men of all ages, this adverse event is even more rare.

Learn more about TTS and the Johnson & Johnson vaccine here.

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Compare the Three Vaccines:

Learn more about ingredients, safety data, side effects, and demographics from clinical trials below.

 

Janssen Moderna Pfizer​

 

 

Is it OK for Me to Get the Vaccine?

Vaccine Ingredients and Allergy Information (7.30.21)| Español

 

Vaccine Safety Monitoring

 

V-safe Poster
V-safe Poster

V-SAFE Vaccine Safety Monitoring

Vaccine safety has been and will continue to be one of CDC’s top priorities. Once COVID-19 vaccines are made available in the United States, CDC will rely on existing systems and a new system, V-Safe, to monitor vaccine safety.

V-Safe is a smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins after someone receives a COVID-19 vaccination. Through V-Safe, vaccine recipients can quickly tell CDC if they have any side effects after getting the COVID-19 vaccine. Depending on their responses, CDC may follow up with them by phone to get more information. V-Safe will also remind them to get their second COVID-19 vaccine dose, if needed.

The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program run by CDC and the Food and Drug Administration (FDA). VAERS serves as an early warning system to detect possible safety issues with U.S. vaccines by collecting information about adverse events (possible side effects or health problems) that occur after vaccination.

V-safe After Vaccination Health Checker

 

How to Report Adverse Events to VAERS:

There are 2 ways to submit a report to VAERS:

 

Option 1: Submit a VAERS Report online (Preferred)
The online VAERS Report must be completed and submitted in the same session; it cannot be saved and edited at a later time.

Note: sessions time out after 20 minutes of inactivity; no information is saved.

 

Report to VAERS
Report to VAERS

Option 2: Download a Writable PDF Form and upload when ready
The Writable PDF Form can be downloaded and completed electronically on your own time. When ready, return to the VAERS Writable PDF web page (use link above) and follow Step 2 instructions to upload the form.

 

More information on reporting an adverse event to VAERS. If you need further assistance, please email info@VAERS.org or call 1-800-822-7967.

 

More Information about VAERS

 


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