Medical Overview: 2023-2024 COVID-19 Vaccines

Introduction

Extreme acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is a extremely transmissible and pathogenic coronavirus that emerged in late 2019 and precipitated a worldwide pandemic of COVID-19.¹ COVID-19 precipitated excessive morbidity and mortality and important social and financial disruption worldwide.

Throughout the Federal COVID-19 Public Well being Emergency (PHE), which lasted from January 31, 2020, till Might 11, 2023, the federal government offered wanted companies reminiscent of free group COVID-19 testing, remedy, and vaccination.² Whereas the federal government will proceed to offer free at-home COVID-19 speedy exams, this fall marks the primary time the COVID-19 vaccines will transition to the business market, non-public and public payers, and conventional pathways of procurement, distribution, and cost.^3,4

Regardless of the tip of the federal PHE interval, SARS-COV-2 continues to develop with new variants inflicting speedy transmission. In the US, COVID-19-related deaths elevated by roughly 18% between July 8, 2023, and August 26, 2023, whereas COVID-19 associated hospitalizations elevated by about 16% inside the same timeframe.⁵

People 65 years of age and older and people with reasonably or severely immunocompromising circumstances are on the best danger of extreme COVID-19. Vaccination stays the very best safety towards COVID-19 associated hospitalization and loss of life.

In June 2023, the FDA’s Vaccines and Associated Organic Merchandise Advisory Committee (VRBPAC) unanimously voted to suggest that the 2023-2024 formulation of the COVID-19 vaccines be up to date to a monovalent COVID-19 vaccine with an XBB-lineage of the Omicron variant.⁶ Primarily based on proof and different issues mentioned, the committee particularly beneficial that the vaccines present protection of XBB.1.5.

On the time, XBB sublineages had been dominant globally and antigenically distant from prior Omicron strains.⁷ Whereas the earlier bivalent vaccines maintained efficacy towards XBB sublineages, they confirmed indicators of waning, together with towards extreme COVID-19 illness.^8-10

Higher matched vaccines towards present circulating strains would assist enhance safety.¹¹ The aim of this evaluate is to summarize present details about the 2023-2024 COVID-19 vaccines together with suggestions from the Facilities for Illness Management (CDC) Advisory Committee on Immunization Practices (ACIP) on who and when people ought to get an up to date vaccine dose.

Accessible COVID-19 Vaccines

At present, there are 3 COVID-19 vaccines out there (Desk 1).^12-16 On September 11, 2023, the FDA approved the 2023-2024 mRNA vaccines manufactured by Moderna and Pfizer-BioNTech.¹⁷

Each mRNA vaccines are FDA-approved for people aged 12 years and older and have emergency use authorization (EUA) for six months to 11 years of age. The Novavax vaccine, which accommodates a purified recombinant spike S antigen of the SARS-CoV2 virus, has EUA for people aged 12 years and older.

On October 3, 2023, the FDA approved the up to date 2023-2024 formulation of the Novavax vaccine.^18,19 The unique monovalent and bivalent (authentic and BA.4/BA.5) mRNA vaccines are now not approved and shouldn’t be used.¹⁷ Janssen’s Ad26.CoV2.S adenovirus vector vaccine was voluntarily withdrawn from market on Might 22, 2023, and can also be now not out there.²⁰

The up to date vaccines are designed to focus on the COVID-19 omicron XBB.1.5 subvariant. Each mRNA vaccines and the Novavax vaccine elicit mobile immune response to the SARS-CoV-2 floor spike S protein.^12-16

The S protein is a viral floor glycoprotein that acknowledges and binds to the host cell, permitting for viral fusion and entry. The mRNA vaccines ship mRNA into the cell which then produces the SARS-CoV-2 spike S protein that the mRNA encodes.

The Novavax vaccine accommodates purified recombinant SARS-CoV-2 spike S antigen and is extra like a conventional vaccine. Neutralizing antibodies bind to the SARS-CoV-2 spike protein and stop its attachment to the host cell, thereby conferring immunity.

Each Pfizer and Moderna report that their vaccines even have exercise towards the present dominant circulating pressure, EG.5 (Eris) and BA.2.8.6 (Pirola), a brand new extremely mutated omicron sublineage of SARS-CoV-2.^21,22

Guideline Suggestions

On September 12, 2023, the CDC ACIP launched suggestions for 2023-2024 COVID-19 vaccinations.²³ The suggestions range in line with age group, COVID-19 vaccination historical past, and presence or absence of reasonable or extreme immunocompromise (Tables 2 and three).²⁴ The up to date suggestions have been streamlined for sure age teams.

For instance, kids who’re 5 years of age can get 1 dose of both mRNA vaccine as a result of the mRNA vaccines have harmonized dosing for this specific age. In earlier years, the numbers of doses different for 5-year-olds as a result of producers used completely different age cutoffs of their research. As well as, kids 6 months to 11 years of age will obtain the identical dose of Moderna (25 mcg), whereas in earlier years there have been completely different doses assigned to completely different age ranges inside this age group.

CDC ACIP recommends that every one people 6 months of age and older obtain an up to date mRNA vaccine. Unvaccinated kids aged 6 months to 4 years of age with out reasonable or extreme immunocompromise ought to obtain a main vaccination sequence with the up to date COVID-19 mRNA vaccine, both 2 doses of Moderna or 3 doses of Pfizer-BioNTech.

As well as, all kids aged 6 months to 4 years of age and/or people with reasonably or severely immunocompromising circumstances might have lowered vaccine response and will obtain all doses from the identical producer (homologous dosing) if potential.²⁴ Reasonably or severely immunocompromising circumstances embrace main immune deficiency ailments (e.g., widespread variable immunodeficiency illness, extreme mixed immunodeficiency, DiGeorge syndrome, Wiskott-Aldrich syndrome), HIV an infection, or lively remedy with immunosuppressive or immunomodulatory therapies, together with high-dose corticosteroids (i.e., 20 mg or extra of prednisone or equal per day when administered for two or extra weeks), transplant-related medication, most cancers chemotherapeutic brokers, tumor necrosis issue receptor antagonists, and different biologic brokers (e.g., B-cell-depleting brokers).²⁴

Medical Efficacy

As of this writing, preliminary human medical trial information are solely out there for the up to date Moderna vaccine. On this trial, 101 adults who had beforehand obtained a main vaccination sequence in addition to 2 booster doses of previous mRNA vaccine formulations had been randomized to obtain a single dose of both a monovalent XBB.1.5 mRNA vaccine or a bivalent formulation containing XBB.1.5 and BA.4/5 mRNA vaccine.^21,25

People who obtained the monovalent XBB.1.5 vaccine elicited a better neutralizing antibody response at 15 days post-dose towards XBB.1.5 in comparison with the bivalent formulation and with related adversarial results as earlier vaccine formulations. The preclinical information from Pfizer-BioNTech and Novavax confirmed elevated neutralizing antibody response to XBB.1.5 pseudoviruses following vaccine administration to mice and macaques, respectively.^22,26

Human research involving COVID-19 vaccines are ongoing. Well being care suppliers ought to report vaccine administration errors and vaccine-related adversarial occasions to the Vaccine Adversarial Occasion Reporting System (VAERS).²⁷

Security

The adversarial results (AEs), contraindications, warnings and precaution info aren’t anticipated to be completely different from earlier COVID-19 vaccine formulations. Primarily based on earlier expertise with the vaccines, the most typical AEs amongst people aged 12 years and older are injection web site ache (as much as 90% incidence), fatigue (as much as 78% incidence), headache (as much as 75% incidence), and myalgia (as much as 50% incidence).^12-16 Amongst kids aged 6 months to 11 years, the most typical AEs for the mRNA vaccines are injection web site redness, swelling, and ache.^12-16

The COVID-19 vaccines are contraindicated in people with a identified historical past of extreme allergic response (e.g., anaphylaxis) to any element of the vaccine. People who’ve skilled an allergic response to a COVID-19 vaccine previously ought to keep away from subsequent doses of the identical COVID-19 vaccine sort (i.e., mRNA vs non-mRNA); nonetheless, they could obtain the alternate sort of COVID-19 vaccine.²⁴

Not one of the vaccines comprise preservatives. The vial stoppers, prefilled syringe tip caps, and plunger stoppers don’t comprise rubber latex.^12-16

Postmarketing information for the entire COVID-19 vaccines exhibit an elevated danger of myocarditis and pericarditis, notably amongst adolescent and grownup males youthful than 40 years of age.²⁸ In response to the producers, the best danger is amongst males between 12 and 17 years of age with the Pfizer-BioNTech vaccine and between 18 and 24 years of age with the Moderna vaccine.^12-15

Instances of myocarditis and pericarditis had been additionally recognized in medical trials with the Novavax COVID-19 vaccine and have been reported through the post-authorization interval.^16,29 Instances have occurred most often inside 7 days following the second dose within the main vaccine sequence; nonetheless, instances have been noticed following the primary dose within the main vaccine sequence and booster doses as properly.

Extending the interval to eight weeks between the primary and second doses might cut back the danger of myocarditis and pericarditis.²⁴ People who develop myocarditis or pericarditis inside 3 weeks after a COVID-19 vaccine ought to typically keep away from any subsequent doses. People who developed myocarditis or pericarditis greater than 3 weeks after a COVID-19 vaccine dose might obtain subsequent doses of any COVID-19 vaccine after the episode of myocarditis or pericarditis has resolved.²⁴

Multisystem inflammatory syndrome in kids (MIS-C) and multisystem inflammatory syndrome in adults (MIS-A) are uncommon problems of SARS-CoV-2 an infection characterised by delayed-onset, post-viral myocarditis and inflammatory vasculopathies.^24,25 People with historical past of MIS-C or MIS-A might have an elevated danger for an MIS-like sickness or myocarditis following COVID-19 vaccination. In response to the CDC, advantages of vaccination outweigh the danger of triggering an MIS-like sickness for people with historical past of MIS-C or MIS-A so long as they’ve achieved clinically restoration, together with return to baseline cardiac perform, and at the least 90 days have elapsed for the reason that final prognosis of MIS-C or MIS-A.²⁴

As a result of syncope might happen following any injectable vaccine, suppliers ought to contemplate monitoring vaccine recipients on-site for quarter-hour after vaccination.²⁴ People who’ve skilled anaphylaxis attributable to any trigger must be monitored for half-hour.²⁴ Medical remedy for anaphylaxis must be instantly out there if wanted.

Drug Interactions

The prescribing info and reality sheets for the COVID-19 vaccines don’t present info on drug interactions with the vaccine.^12-16 Nonetheless, as a result of concomitant use of immunosuppressants might result in diminished vaccine response, COVID-19 vaccines must be administered at the least 2 weeks earlier than initiation or resumption of immunosuppressive therapies, if potential.²⁴ 

Affected person receiving B-cell depleting therapies on a seamless foundation ought to obtain COVID-19 vaccines roughly 4 weeks earlier than the subsequent scheduled remedy. The American School of Rheumatology (ACR) presents steerage to be used and timing of immunomodulatory therapies in relation to COVID-19 vaccination in people with rheumatic and musculoskeletal illness.³² For instance, the ACR recommends that subcutaneous abatacept (Orencia, E.R. Squibb & Sons) and belimumab (Benlysta, GlaxoSmithKline) be withheld for 1 to 2 weeks, as illness exercise permits, after a COVID-19 vaccine dose.

People who’ve dermal fillers might expertise elevated swelling at or close to the positioning of the dermal filler injection following receipt of an mRNA vaccine and will require further counseling and monitoring for this AE.^33,34

Administration With Different Vaccines

It’s acceptable to manage the COVID-19 vaccine, influenza vaccine, and respiratory syncytial virus vaccine on the similar go to to eligible sufferers.²⁴ That is in accordance with normal greatest practices for immunization.³⁵

People, notably adolescent or younger grownup males, who’ve obtained an orthopoxvirus vaccination (Jynneos, ACAM2000, Imvamume) ought to contemplate ready at the least 4 weeks after the orthopoxvirus vaccine earlier than receiving a COVID-19 vaccine. The COVID-19 vaccine has been noticed to boost the danger of myocarditis and pericarditis associated to the orthopoxvirus vaccines. If the COVID-19 vaccine is run first, then there is no such thing as a minimal time interval crucial between the COVID-19 vaccine and orthopoxvirus vaccination.²⁴

Storage

The Pfizer-BioNTech COVID-19 vaccine could also be saved in an ultracold freezer, between -90°C and -60°C (-130°F and -76°F), till the producer expiration date.^12,13 In any other case they are often saved within the fridge, between 2°C and eight°C (36° and 46°F), for as much as 10 weeks or at room temperature between 8°C and 25°C (46° and 77°F) for as much as 12 hours.

The Moderna vaccine could also be saved within the freezer till the producer expiration date, as much as 30 days within the fridge, or as much as 24 hours at room temperature.^14,15 The Novavax vaccine might be saved at room temperature till the expiration date.¹⁶

Secure Remedy Practices

As a result of a number of formulations of COVID-19 vaccines can be found, pharmacies ought to proceed with security methods to make sure vaccination with the age-appropriate formulation, appropriate dose, and any preparation necessities, e.g., dilution (Desk 4).

Security methods are additionally wanted to safeguard towards lookalike-soundalike errors. The Institute for Secure Remedy Practices (ISMP) has issued alerts on remedy errors stemming from confusion between COVID-19 vaccines, influenza vaccines, and epinephrine injection vials, notably when merchandise had been saved in shut proximity.^36,37

Insurance coverage Protection

Most People will proceed to pay nothing out-of-pocket for the COVID-19 vaccine attributable to their insurance coverage protection. The Bridge Entry Program for COVID-19 vaccines and remedy is a public-private partnership that may function a short lived measure to forestall the lack of under- and uninsured adults’ entry to COVID-19 vaccines and coverings without charge after the vaccines enter the business market.³⁸ The Bridge Entry Program will proceed by way of the tip of 2024.

Conclusion

The 2023 fall season marks the primary time that the COVID-19 vaccines will transition from authorities distribution to business channels. The up to date 2023-2024 formulations of the vaccine goal the SARS-CoV-2 omicron XBB.1.5 variant.

Up to date CDC suggestions for COVID-19 vaccination varies relying on age group, COVID-19 vaccination historical past, and presence of reasonable or extreme immunocompromise. Most plans and insurers will cowl COVID-19 vaccination with out cost-sharing. People with out insurance coverage can receive COVID-19 vaccine by way of the Bridge Entry Program.

References

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