Moderna COVID-19 Vaccine (Spikevax) Approval

On January 31, 2022, the FDA granted full approval for Moderna COVID-19 Vaccine (with the trade name of Spikevax) for use as a two-dose series for the prevention of COVID-19 disease in individuals 18 years of age and older.

On February 4, 2022, the Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend the Moderna COVID-19 vaccine (Spikevax) under FDA’s Biologics License Application (BLA). The presentation slides and other resources from the ACIP meeting can be found here.

Spikevax and the EUA-authorized Moderna COVID-19 Vaccine (still under EUA for booster and additional doses) have the same formulation and can be used interchangeably. The Fact Sheet for Recipients provides additional information about both the approved and authorized vaccine. Providers should continue to use-up existing supplies of Moderna COVID-19 vaccine.

Resources

Spikevax and Moderna – EUA Fact Sheet for Healthcare Providers

Who Needs an Additional COVID-19 Vaccine?

Currently, CDC is recommending that moderately to severely immunocompromised people receive an additional dose because they are more at risk of serious, prolonged illness.

This includes people who have:

  • Been receiving active cancer treatment for tumors or cancers of the blood
  • Received an organ transplant and are taking medication to suppress the immune system
  • Received a stem cell transplant within the last 2 years or are taking medicine to suppress the immune system
  • Moderate or severe primary immunodeficiency (such as DiGeorge Syndrome, Wiskott-Aldrich Syndrome)
  • Advanced or untreated HIV infection
  • Active treatment with high-dose corticosteroids or other drugs that may suppress your immune response

People should talk to their healthcare provider about their medical condition, and whether getting an additional dose appropriate for them.

Who qualifies for a medical exemption from being vaccinated against COVID-19?

The only definite medical contraindication to the COVID-19 is a documented, severe, anaphylactic allergic reaction to a first dose of COVID-19 vaccine.

SBNC clinicians will only write medical exemptions for the reason listed above.

Click here to see SB County’s summary on COVID-19

Here are the latest COVID-19 numbers. It is recommended to receive a booster dose 5 months after you completed the two dose series with Pfizer-BioNTech or Moderna. You may get Johnson & Johnson’s Janssen COVID-19 booster as least 2 months after receiving your the first dose.  For more information on receiving your booster, please visit CDC.Gov

36 Daily New Cases

Chart update: May 10, 2022.

 

Click here to view the County of Public Health’s vaccine schedule.

Santa Barbara Neighborhood Clinics continues to serve our community with high quality affordable healthcare during the COVID-19 pandemic.

Given what we currently know about COVID-19 and the Omicron variant, CDC is shortening the recommended time for isolation for the public. People with COVID-19 should isolate for 5 days and if they are asymptomatic or their symptoms are resolving (without fever for 24 hours), follow that by 5 days of wearing a mask when around others to minimize the risk of infecting people they encounter. The change is motivated by science demonstrating that the majority of SARS-CoV-2 transmission occurs early in the course of illness, generally in the 1-2 days prior to onset of symptoms and the 2-3 days after.

Additionally, CDC is updating the recommended quarantine period for anyone in the general public who is exposed to COVID-19. For people who are unvaccinated or are more than six months out from their second mRNA dose (or more than 2 months after the J&J vaccine) and not yet boosted, CDC now recommends quarantine for 5 days followed by strict mask use for an additional 5 days. Alternatively, if a 5-day quarantine is not feasible, it is imperative that an exposed person wear a well-fitting mask at all times when around others for 10 days after exposure. Individuals who have received their booster shot do not need to quarantine following an exposure, but should wear a mask for 10 days after the exposure.  For all those exposed, best practice would also include a test for SARS-CoV-2 at day 5 after exposure. If symptoms occur, individuals should immediately quarantine until a negative test confirms symptoms are not attributable to COVID-19.

Isolation relates to behavior after a confirmed infection. Isolation for 5 days followed by wearing a well-fitting mask will minimize the risk of spreading the virus to others. Quarantine refers to the time following exposure to the virus or close contact with someone known to have COVID-19. Both updates come as the Omicron variant continues to spread throughout the U.S. and reflects the current science on when and for how long a person is maximally infectious. These recommendations do not supersede state, local, tribal, or territorial laws, rules, and regulations, nor do they apply to healthcare workers for whom CDC has updated guidance.

Data from South Africa and the United Kingdom demonstrate that vaccine effectiveness against infection for two doses of an mRNA vaccine is approximately 35%. A COVID-19 vaccine booster dose restores vaccine effectiveness against infection to 75%. COVID-19 vaccination decreases the risk of severe disease, hospitalization, and death from COVID-19. CDC strongly encourages COVID-19 vaccination for everyone 5 and older and boosters for everyone 16 and older. Vaccination is the best way to protect yourself and reduce the impact of COVID-19 on our communities.

The following is attributable to CDC Director, Dr. Rochelle Walensky:

“The Omicron variant is spreading quickly and has the potential to impact all facets of our society. CDC’s updated recommendations for isolation and quarantine balance what we know about the spread of the virus and the protection provided by vaccination and booster doses. These updates ensure people can safely continue their daily lives. Prevention is our best option: get vaccinated, get boosted, wear a mask in public indoor settings in areas of substantial and high community transmission, and take a test before you gather.”

 

If You Test Positive for COVID-19 (Isolate)

Everyone, regardless of vaccination status.

  • Stay home for 5 days.
  • If you have no symptoms or your symptoms are resolving after 5 days, you can leave your house.
  • Continue to wear a mask around others for 5 additional days.

If you have a fever, continue to stay home until your fever resolves.

If You Were Exposed to Someone with COVID-19 (Quarantine)

If you:

Have been boosted
OR
Completed the primary series of Pfizer or Moderna vaccine within the last 6 months
OR
Completed the primary series of J&J vaccine within the last 2 months

  • Wear a mask around others for 10 days.
  • Test on day 5, if possible.

If you develop symptoms get a test and stay home.

If you:

Completed the primary series of Pfizer or Moderna vaccine over 6 months ago and are not boosted
OR
Completed the primary series of J&J over 2 months ago and are not boosted
OR
Are unvaccinated

  • Stay home for 5 days. After that continue to wear a mask around others for 5 additional days.
  • If you can’t quarantine you must wear a mask for 10 days.
  • Test on day 5 if possible.

 

If you develop symptoms get a test and stay home

Santa Barbara Neighborhood Clinics is now offering all three of the COVID-19 vaccines in its clinics. If you have not received yours, call us today to schedule your appointment at (844) 594-0343 

Currently, we are administering second doses to those whom we have administered first doses and will continue to do so until all required second doses have been completed. Our call center does not have the capability of scheduling the vaccination appointments, so we request that it not be utilized to schedule COVID-19 vaccine appointments .

What is COVID-19?

Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus.

Most people infected with the COVID-19 virus will experience mild to moderate respiratory illness and recover without requiring special treatment.  Older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness.

The best way to prevent and slow down transmission is to be well informed about the COVID-19 virus, the disease it causes and how it spreads. Protect yourself and others from infection by washing your hands or using an alcohol based rub frequently and not touching your face.

The COVID-19 virus spreads primarily through droplets of saliva or discharge from the nose when an infected person coughs or sneezes, so it’s important that you also practice respiratory etiquette (for example, by coughing into a flexed elbow).

Prevention

To prevent infection and to slow transmission of COVID-19, do the following:

  • Wash your hands regularly with soap and water, or clean them with alcohol-based hand rub.
  • Maintain at least 6 feet apart in distance between you and people coughing or sneezing.
  • Avoid touching your face.
  • Cover your mouth and nose when coughing or sneezing.
  • Stay home if you feel unwell.
  • Refrain from smoking and other activities that weaken the lungs.
  • Practice physical distancing by avoiding unnecessary travel and staying away from large groups of people, especially outside your household and always wear a mask when doing so.

Symptoms

COVID-19 affects different people in different ways. Most infected people will develop mild to moderate illness and recover without hospitalization.

Most common symptoms:

  • fever.
  • dry cough.
  • tiredness.

Less common symptoms:

  • aches and pains.
  • sore throat.
  • diarrhea.
  • conjunctivitis.
  • headache.
  • loss of taste or smell.
  • a rash on skin, or discoloration of fingers or toes.

Serious symptoms:

  • difficulty breathing or shortness of breath.
  • chest pain or pressure.
  • loss of speech or movement.

Seek immediate medical attention if you have serious symptoms.  Always call before visiting your doctor or health facility.

People with mild symptoms who are otherwise healthy should manage their symptoms at home.

On average it takes 5–6 days from when someone is infected with the virus for symptoms to show, however it can take up to 14 days.

Frequently Asked Questions

Can adolescents catch COVID-19?

Yes. All age groups can catch COVID-19.

What should I do if someone in my family gets really ill with COVID-19?

Immediately seek medical care if a member of your family gets seriously ill, for example develops difficulty breathing or feels pain or pressure in the chest. If possible, either you or an adult should contact your health care provider or COVID-19 hotline for instructions and find out where and how you could get care. If your family member is confirmed as having COVID-19, you must be prepared that you and other known contacts will need to isolate for 14 days and monitor symptoms, even if you feel healthy.

I am on medication for a chronic health condition. Should I change anything?

For people with chronic conditions such as such as asthma, diabetes, TB and HIV the most important thing is to continue your medication as prescribed, attend recommended check-ups and seek medical help if you have new symptoms. ALWAYS check with your healthcare provider on how to be protected from COVID-19 and continue your treatment as prescribed.

I am feeling really anxious about COVID-19 and its impact on my life. What should I do?

In situations like a pandemic it is very normal to feel anxious and powerless, many other different feelings: worry, frustration, sad, stress, anger and that is okay. We have licensed clinical social workers available for counseling and to go over your behavioral well being.

I was in close contact with someone who tested positive for COVID-19, but I feel fine. What should I do?

If you have been in close contact with someone who has tested positive for COVID-19, even if you feel well now, if is possible that you are also infected. It can take 2-14 days to show symptoms, so it may take up to 14 days to know if you are infected or not. Self-quarantine and check with your provider if you should get tested.

What if I drink alcohol the night before I get my vaccination?

Drinking alcohol won’t make the vaccine any less effective and shouldn’t make the side effects any worse than a hangover.

How long do I have to wait until I get my second dose of the vaccine?

28 Days.

What are the long term effects of the vaccine?

Long term effects are still unknown; however, short term side effects are sore arm, possible fever, aches, fatigue. In rare cases, an allergic reaction can occur. We will be prepared to manage these short term side effects.

Should I get the vaccine if I am breastfeeding or going through treatment?

The two vaccines were not tested on pregnant or breastfeeding moms; however, there are no viruses in these products. They contain a copy of the “code” from which the virus makes the spike protein which it attaches to our cells. Once stimulated, our immune systems will make antibodies against that part of the virus rendering it incapable of attaching to our cell. Because of this mechanism, it is felt that theses vaccines are safe for pregnant and breast feeding mothers, as well as those hoping to become pregnant. The risk to the mom or breastfeeding baby from the actual COVID-19 infection is far greater than any risk from the vaccine that prevents it. There is no evidence or scientific basis for an effect on future fertility with the vaccine.

Can you still get COVID-19 after taking the second dose of the vaccine?

Yes.

Which similar vaccines have been FDA approved?

Only the Pfizer and Moderna vaccines have been approved by the FDA for EMERGENCY USE ONLY. There are no vaccines that have been fully approved without the Emergency Use determination. We do not yet know when any COVID-19 vaccine will get full approval outside the Emergency Use Waiver. The companies will continue to collect data on the vaccine and serious side effects and effectiveness to move forward towards full FDA approval and to recognize possible late presenting complications or contraindications.

In terms of ingredients, how is this vaccine similar to others?

Ingredients include the mRNA, Lipid carriers, salts, sugars and buffers, all common ingredients in foods and other medications. The vaccine ingredients are probably healthier for you than a soda pop!

Are there any side effects with diabetic or hypertension medications?

The studies included persons with diabetes and hypertension among other chronic illnesses and no known specific complications were identified and listed as contraindication to the vaccine.

After the vaccine what should one do if they develop symptoms?

Everyone’s body is different. Common Side Effects include: Nausea, Chills, Fever, Soreness, Fatigue. If you have what you think are vaccine related side effects please inform your healthcare provider. If you develop COVID-19 symptoms you will need to be tested / or manage as if you didn’t get the vaccine since it is not 100% effective and there is a small chance you could still get COVID-19 disease.

Will we need to still wear masks after the vaccine?

Yes. Until most (>70%) of persons in the community are vaccinated there will still be the chance to get the infection. This level is when we may reach “herd immunity” and the disease will be mostly suppressed. If the virus can’t find a non-immune “host” it will die away. Like measles. Or mumps. Or chickenpox. Or smallpox. Or polio.

How much does it cost to get the vaccine?

Currently , the vaccine is being provided free of charge by the government in order to get the highest level of people vaccinated against the Corona virus. When we provide this to others we may bill a Vaccine Administration charge.

If I get symptoms from the vaccine, do I need to isolate from my family household?

No, you will not have COVID-19. These are side effects, not the disease.

Myth Busting: True or False

Spraying and introducing bleach or another disinfectant into your body will protect you against COVID-19 and considered safe.

FALSE, these substances can be poisonous if ingested and cause irritation and damage to your skin and eyes or worse, fatal incidences. DO NOT CONSUME.

Once you get COVID-19, you will become immune and do not need to take the vaccine.

FALSE, you can still get COVID-19 even after already being positive before. The vaccine decreases your risk of getting it by 94.5% after the second dose of the vaccine.

You can get COVID-19 through mosquito bites.

FALSE, to date there has been no information nor evidence to suggest that the new coronavirus can be transmitted by mosquitoes. The new coronavirus is a respiratory virus which spreads primarily through droplets generated when an infected person coughs or sneezes, or through droplets of saliva or discharge from the nose.

People of all ages can be infected by the COVID-19 virus.

TRUE, Older people and younger people can be infected by the COVID-19 virus. Older people, and people with pre-existing medical conditions such as asthma, diabetes, and heart disease appear to be more vulnerable to becoming severely ill with the virus.

COVID-19 can spread from your shoes.

FACT, although it is extremely low. As a precautionary measure, particularly in homes where infants and small children crawl or play on floors, consider leaving your shows at the entrance of your home. This will help prevent contact with dirt or any waste that could be carried on the soles of shoes.

There is a small amount of the virus inside the vaccine.

FALSE, there is a new technology using something called Messenger RNA to stimulate the persons own immune system.

The vaccine was developed too fast and isn't safe to get.

FALSE, well established vaccine technology that has been used for many years in other vaccines was utilized in the rapid development of these vaccines. The Moderna and Pfizer vaccines are the first to use mRNA (messenger RNA) to be effective, but mRNA technology is not new in other areas of the medical field. These are lean and clean and highly effective vaccines with very few ingredients, all of which are used commonly in medications and other products.

People can get cancer or become infertile from the vaccine.

FALSE, there is no reason to think based on science of the vaccine that it would cause cancer or infertility issues.

The COVID-19 vaccine has a microchip for the government to track you.

FALSE, the shipping container for the Pfizer vaccine contains a chip for tracking. The vaccine itself has no chip.

Aerosols vs. Droplets