No, do not reserve any COVID-19 vaccine doses for the second dose administration. For example, if you receive 100 doses, administer it to 100 patients. Second doses will be taken into account with future allocations.

The FDA is aware of this issue, and it's working with Pfizer to determine the best path forward and will share additional updates when available. At this time, given the public health emergency, the FDA is advising that it is acceptable to use every full dose obtainable (the sixth, or possibly even a seventh) from each vial, pending resolution of the issue. However, since these are preservative free vials, it is critical to note that any further remaining liquid that does not constitute a full dose should not be pooled from multiple vials to create one.

References

Owermohle S. FDA says Pfizer vaccine vials hold extra doses, expanding supply. https://www.politico.com/news/2020/12/16/pfizer-vaccine-extra-doses-447117

A new variant of the virus that causes COVID-19 has been identified in the United States, the United Kingdom, and 30 other countries. The new variant appears to be a more contagious form of COVID-19. Currently, this variant does not seem to make individuals sicker or lead to more deaths. Cases have now been reported in three US states (Colorado, California and Florida) and are not known to be linked to travel, which could indicate community spread. No cases caused by this new variant have been confirmed in Illinois yet. As more information is learned, IDPH will provide updates and notify the public if/when the variant is detected in Illinois. Illinois is increasing its surveillance for the variant by performing additional genomic testing on an increased number of specimens that have been collected.

For additional information, please go to the Illinois Department of Public Health website. https://www.dph.illinois.gov/covid19/faq/new-variant

References

Florida Department of Public Health. New COVID-19 variant found in Florida, marking the nations third confirmed case. New COVID-19 variant found in Florida, marking the nation’s 3rd confirmed case | WFLA Accessed December 31, 2020.

The CDC defines an immediate allergic reaction to a vaccine or medication as any hypersensitivity-related signs or symptoms such as urticaria, angioedema, respiratory distress (e.g., wheezing, stridor), or anaphylaxis that occur within four hours following administration. Recommendations for patients with immediate allergic reactions to prior COVID-19 vaccinations or components of these vaccines are outlined in the next FAQ and in the referenced link below.

For additional information, please go to:

https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html?CDC_AA_refVal=https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/clinical-considerations.html

CDC considers a history of the following to be a contraindication to vaccination with both the Pfizer-BioNTech and Moderna COVID-19 vaccines:

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine or any of its components
• Immediate allergic reaction of any severity to a previous dose of an mRNA COVID-19 vaccine or any of its components (including polyethylene glycol [PEG])*
• Immediate allergic reaction of any severity to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG)*

* These persons should not receive mRNA COVID-19 vaccination at this time unless they have been evaluated by an allergist-immunologist and it is determined that the person can safely receive the vaccine (e.g., under observation, in a setting with advanced medical care available). Persons with an immediate allergic reaction to the first dose of an mRNA COVID-19 vaccine should not receive additional doses of either of the mRNA COVID-19 vaccines.

For additional information, please go to:

https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html?CDC_AA_refVal=https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/clinical-considerations.html

To review a CDC webinar regarding updates on allergic Reactions, contraindications, and precautions to COVID-19 vaccinations, please go to:

https://emergency.cdc.gov/coca/calls/2020/callinfo_123020.asp

CDC recommends an observation period following vaccination with mRNA COVID-19 vaccines. Persons with a history of an immediate allergic reaction of any severity to a vaccine or injectable therapy and persons with a history of anaphylaxis due to any cause should be observed for 30 minutes. All other persons should be observed for 15 minutes.

For additional information, please go to:

https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html?CDC_AA_refVal=https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/clinical-considerations.html">

A patient requested her COVID-19 vaccine be given in her thigh rather than the deltoid muscle of the arm, due to previous double mastectomy. Can either of the COVID-19 vaccines be given at a site other than the deltoid muscle of the arm?

The Centers for Disease Control (CDC) state that the anterolateral thigh can also be used as an injection site for either the Moderna or the Pfizer-BioNTech COVID-19 vaccines.

References

Centers for Disease Control. Pfizer-BioNTech COVID-19 Vaccine Standing Orders for Administering Vaccine to Persons 16 Years of Age and Older. https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/downloads/standing-orders.pdf. Accessed January 13,2021

Centers for Disease Control. Moderna COVID-19 Vaccine Standing Orders for Administering Vaccine to Persons 18 Years of Age and Older https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/downloads/standing-orders.pdf

Experiments indicate the vaccine from Pfizer (Pfizer/BioNTech) may offer protection against the two new coronavirus variants found in the South Africa and the United Kingdom.

The existence of the coronavirus variants was first reported in December in the United Kingdom. These variants appear to be more infectious than the original coronavirus, but no more lethal. The UK variant has been found in more than 30 countries and at least six states in the US.

Researchers from the University of Texas Medical Branch and Pfizer and developed a version of these new coronavirus variants in their laboratories. They examined blood samples from people who had been given the Pfizer vaccine and found that antibodies from those people were able to fight off the coronavirus virus variant.

These laboratory experiments suggest that the people who had been given the Pfizer vaccine may be protected from infections by these variants.

This research was published Thursday but has not been peer reviewed and did not study the full range of possible virus mutations.

Moderna CEO Stephane Bancel, said his company is also testing their vaccine, which is similar to Pfizer's, against these variants and believes it will also prove effective against the UK coronavirus variant.

References

CNN. "Pfizer's Covid-19 vaccine appears to work against mutation in new variants, study finds" https://edition.cnn.com/world/live-news/coronavirus-pandemic-vaccine-updates-01-08-21/h_88ad22369cb962cad5c9d8f9cb514453?utm_content=2021-01-08T10%3A00%3A42&utm_medium=social&utm_source=fbCNNi&utm_term=link&fbclid=IwAR1BxVkYLTWY-eZMVWf0A6-oj1vtJFeXreIlhCdD5RIsSIUYNj_DbWJPzWg.

MSN. "Pfizer COVID-19 vaccine likely to work against new, rapidly-spreading variants: Study" https://www.msn.com/en-us/health/medical/pfizer-covid-19-vaccine-likely-to-work-against-new-rapidly-spreading-variants-study/ar-BB1czWoX?ocid=uxbndlbing.

BioRXiv. "Neutralization of N501Y mutant SARS-CoV-2 by BNT162b2 vaccine-elicited sera" https://www.biorxiv.org/content/10.1101/2021.01.07.425740v1.

A New Vaccine by Johnson & Johnson

THIS IS A SINGLE DOSE VACCINE

Johnson & Johnson (J&J) announced (Feb 4, 2021) it has submitted an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate. the Johnson & Johnson vaccine uses double-stranded DNA.

How Effective is this New Vaccine?  

Although clinical trial data has not yet been made available publicly, the company issued a press release describing some of the key observations. In the U.S., the vaccine had an efficacy rate of 72 percent in clinical trials. But in South Africa, where a new and more contagious COVID mutants has been found, the efficacy rate dropped to 57 percent. However, the vaccine was 85% effective in preventing severe disease (positive COVID-19 test plus one or more of following: tachypnea, tachycardia, hypoxia, hypoxemia, respiratory failure, shock, significant organ dysfunction, intensive care unit admission, or death) and 100% effective in preventing hospitalizations. This new vaccine was tested in more than 43,000 people in United States, Latin America and South Africa, including significant proportion of patients from underrepresented racial and ethnic groups.

How is this New vaccine different?

For this vaccine researchers added a gene for the coronavirus spike protein to another virus called Adenovirus 26. Adenoviruses are common viruses that typically cause colds or flu-like symptoms. The Johnson & Johnson team used a modified adenovirus that can enter cells but can’t replicate inside them or cause illness. This J&J vaccine comes out of decades of research on adenovirus-based vaccines.

Adenovirus-based vaccines for Covid-19 are more rugged than mRNA vaccines from Pfizer and Moderna. As a result, the J&J vaccine is expected to remain stable for two years at -4°F (-20°C), at least three months of which can be stored in most standard refrigerators at temperatures of 36°F–46°F (2°-8°C). 

This will make the Johnson & Johnson’s vaccine easier to distribute, particularly in poorer parts of the world, where issues of storage at cold temperatures will be a problem. Also, the new vaccine should work in countries where the new more aggressive COVID mutants are now causing COVID infections.

What are the Side Effects of this Vaccine?

Side effects appear to be lower with this vaccine than the already approved ones.

J&J reported that 9% of participants got a fever after injection, but less than 1% had a high fever; others reported pain and fatigue, but all side effects were short-lived. No one suffered a severe allergic reaction (anaphylaxis), according to the company.

References

https://www.jnj.com/johnson-johnson-announces-single-shot-janssen-covid-19-vaccine-candidate-met-primary-endpoints-in-interim-analysis-of-its-phase-3-ensemble-trial

https://www.nytimes.com/2021/01/29/health/covid-vaccine-johnson-and-johnson-variants.html?campaign_id=154&emc=edit_cb_20210129&instance_id=26578&nl=coronavirus-briefing&regi_id=96247115&segment_id=50653&te=1&user_id=36afc25c541eebd57c2cd26ff0ed40eb

https://www.usatoday.com/story/news/health/2021/01/29/johnson-covid-vaccine-safe-effective-trials-show/6693563002/

https://www.nature.com/articles/d41586-021-00119-7

Common adverse effects to expect following the currently available COVID-19 vaccines

Necessity of 2 Doses of the Pfizer and Moderna COVID-19 Vaccines

This article explains in laymen's terms what happens to the immune system when people receive a vaccine.

Local dermal reactions to Moderna COVID-19 vaccine