Omicron-Specific Booster Shots: 5 Questions Answered (2022)

The following essay is reprinted with permission from Omicron-Specific Booster Shots: 5 Questions Answered (1)The Conversation, an online publication covering the latest research.

On Aug. 31, 2022, theFood and Drug Administration authorizedthe use of updated COVID-19 booster shots that are specifically tailored to combat the two most recent and contagiousomicron subvariants, BA.4 and BA.5. Following the FDA’s emergency use authorization, the Centers for Disease Control and Prevention is expected to endorse the shots, allowing them to be administered within days.

The new booster shots – one by Moderna and another from Pfizer-BioNTech – come as more than450 people are still dying of COVID-19 every day in the U.S.

As of Aug. 31, 2022, only48.5% of booster-eligible people in the U.S. have received their first booster shot, and just under 34% of those eligible have received their second. These low numbers may in part be influenced bypeople waiting for the newer versions of the vaccinesto provide better protection. But booster shots have proven to be anessential layer of protection against COVID-19.

Prakash NagarkattiandMitzi Nagarkattiare immunologists who study infectious disorders and how vaccines trigger different aspects of the immune system to fight infection. They weigh in on how the updated booster shots train the immune system and how protective they might be against COVID-19.

(Video) Q&A: How effective are omicron-specific boosters?

1. What is different about the updated booster shots?

The newly authorized shots are the first updates to the original COVID-19 vaccines that were introduced in late 2020. They use the samemRNA technology as the original vaccines. The key difference between the original COVID-19 shots and the new “bivalent” version is that the latter consists of a mixture of mRNA that encodes thespike proteinsof both the original SARS-CoV-2 virus and the morerecent omicron subvariants, BA.4 and BA.5.

As of late August 2022, the BA.4 and BA.5 omicron subvariants are dominant worldwide.In the U.S., currently89% of COVID-19 infections are caused by BA.5 and 11% are caused by BA.4.

The inability of the original vaccine strains to prevent reinfection andto trigger long-term protective immunityprompted the need for the reformulated vaccines.

2. How does a bivalent vaccine trigger an immune response?

In an actual COVID-19 infection, the SARS-CoV-2 virus uses its protrudingspike protein to latch onto human cellsand gain entry into cells. The spike protein triggers the production of so-calledneutralizing antibodies, which bind to the spike protein and prevent the virus from invading other cells.

Butwhen the virus mutates, as we know that it does, the antibodies that were previously produced in response to the virus can no longer effectively bind to the newly mutated spike protein. In this respect, the SARS-CoV-2 virus acts like a chameleon – a master of disguise – by changing its body configuration and escaping recognition by the immune system.

The ongoing viral mutations are why antibodies produced in response to the original vaccine strains have over time become less effective at fending off infections by new variants.

The concept of bivalent vaccines aimed at protecting against two different strains of a virus is not new. For instance,Cervarix is an FDA-approved bivalent vaccinethat provides protection against two different types of human papillomaviruses that cause cancer.

(Video) Omicron BA.5 vs. Vaccines and Previous Infection

3. How protective will the new shots be against infection?

There are as of yet no human studies on the efficacy of the new bivalent vaccine at preventing reinfections and providing long-term immune protection.

However, in human clinical trials and laboratory studies,both Pfizer-BioNTech and Moderna foundthat their initial version of the bivalent vaccine, which was directed against the original SARS-CoV-2 virus and an earlier omicron strain, BA.1, induced a strong immune response and longer protection against both the original strain and the BA.1 variant. In addition, the companies reported that the same early combination generated a significant antibody response against the newest omicron subvariants, BA.4 and BA.5, though this antibody response was lower than that seen against subvariant BA.1.

Based on those results, in spring 2022 theFDA rejectedthe BA.1 bivalent boosters because the agency felt the boosters may fall short of providing sufficient protection against the newest strains, BA.4 and BA.5, which were by then spreading quickly throughout the U.S. and the world. So the FDA asked Pfizer-BioNTech and Modernato develop bivalent vaccines specifically targeting BA.4 and BA.5, instead of BA.1.

Because clinical trials are time-consuming, theFDA was willing to consider animal studiesand other laboratory findings, such as the ability of antibodies to neutralize the virus, to decide whether to authorize the bivalent boosters.

This decisionhas stirred up controversyover whether it is appropriate for the FDA to approve a booster without direct human data to support it. However, the FDA has stated that millions of people have safely received the mRNA vaccines – which were originally tested in humans – and that the changes in the mRNA sequences in the vaccinesdo not affect vaccine safety. Thus, it concluded that the bivalent vaccines are safe and that there is no need to wait for human clinical trials.

It is also noteworthy that influenza vaccines are introduced each year based on prediction of the strain that is likely to be dominant,and such formulations do not undergo new clinical trials.

Based on available evidence from the previous COVID-19 vaccines, we believe it is very likely that the new boosters will continue to offer strong protection fromsevere COVID-19 leading to hospitalization and death. But whether they will protect against reinfection and breakthrough infections remains to be seen.

(Video) A Moderna official on COVID vaccines for kids, omicron-specific shot, waiving patents

4. Will it only be a booster shot?

The bivalent vaccinescan only be usedas a booster shot at least two months after the completion of the primary series – or initial required shots – or following a previous booster shot. The Moderna bivalent vaccine is authorized for use in people 18 years of age, while the Pfizer bivalent vaccine is authorized for those 12 years of age and older.

Because of the superiority of the bivalent vaccines, the FDA has also removed the use authorization for the original monovalent Moderna and Pfizer COVID-19 vaccines for booster purposes in individuals 18 years of age and older and 12 years of age and older, respectively.

The newbivalent vaccines contain a lower dose of mRNA, and as such are meant to be used only as boosters and not in people who have never received a COVID-19 vaccination.

5. Will the new shots protect against future variants?

How well the bivalent vaccines will perform in the face of new variants that might arise will depend on the nature of future spike protein mutations.

If it is a minor mutation or set of mutations when compared to the original strain or to omicron variants BA.4 and BA.5, the new shots will provide good protection. However, if a hypothetical new strain were to possess highly unique mutations in its spike protein, then it’s likely that it could once again dodge immune protection.

On the flip side, the successful development of the updated vaccines demonstrates that the mRNA vaccine technology is nimble and innovative enough that – within a couple of months of the emergence of a new variant – it is now likely possible to develop and distribute new vaccines that are tailor-made to fight an emerging variant.

This article was originally published on The Conversation. Read the original article.

(Video) Should you get a COVID-19 booster now or wait for an omicron-specific shot?

ABOUT THE AUTHOR(S)

    Prakash Nagarkatti is a professor of pathology, microbiology and immunology at the University of South Carolina.

      Mitzi Nagarkatti is a professor of pathology, microbiology and immunology at the University of South Carolina.

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        FAQs

        What is in the new updated COVID-19 booster shot? ›

        The authorized bivalent COVID-19 vaccines, or updated boosters, include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 ...

        How long after receiving the COVID-19 booster are you protected? ›

        Generally, people with healthy immune systems are protected from infection for three to four months after receiving a COVID booster, but protection from severe illness lasts eight months to a year.

        Is Pfizer COVID-19 booster safe? ›

        Yes, booster shots are proven to be safe. Pfizer released a study of 10,000 participants in which half of them received a booster dose and half a placebo. In terms of safety, they found no new adverse events, meaning it was consistent with what has been seen in previous studies.

        What is COVID-19 genomic sequencing? ›

        Genomic sequencing is laboratory analysis that identifies a virus's genetic make-up, allowing new variants or mutations in existing variants to be detected.

        Does the COVID-19 AstraZeneca vaccine contain any ingredients that can cause COVID-19? ›

        COVID-19 Vaccine AstraZeneca stimulates the body's natural defences (immune system). It causes the body to produce its own protection (antibodies) against the virus. This will help to protect you against COVID-19 in the future. None of the ingredients in this vaccine can cause COVID-19.

        Do smokers suffer from worse COVID-19 symptoms? ›

        Early research indicates that, compared to non-smokers, having a history of smoking may substantially increase the chance of adverse health outcomes for COVID-19 patients, including being admitted to intensive care, requiring mechanical ventilation and suffering severe health consequences.

        Can you take ibuprofen if you have the coronavirus disease? ›

        Patients can take paracetamol or ibuprofen when self-medicating for symptoms of COVID-19, such as fever and headache, and should follow NHS advice if they have any questions or if symptoms get worse.

        How long does the virus that causes COVID-19 last on surfaces? ›

        Recent research evaluated the survival of the COVID-19 virus on different surfaces and reported that the virus can remain viable for up to 72 hours on plastic and stainless steel, up to four hours on copper, and up to 24 hours on cardboard.

        What are the most common adverse reactions to the COVID-19 vaccine? ›

        The most frequent adverse reactions in trials were pain at the injection site, fatigue, headache, myalgia (muscle pains), chills, arthralgia (joint pains), and fever; these were each reported in more than 1 in 10 people.

        What are the common side effects of the COVID-19 vaccine? ›

        Some people have reported a sudden feeling of cold with shivering/shaking accompanied by a rise in temperature, often with sweating, headache (including migraine-like headaches), nausea, muscle aches and feeling unwell, starting within a day of having the vaccine.

        What are 'nudgeboxes' and what are they used for? ›

        5,000 DNA 'Nudgebox' machines, supplied by DnaNudge, will be rolled out across NHS hospitals in the UK to analyse DNA in nose swabs, providing a positive or negative result for COVID-19 in 90 minutes, at the point of care. The machines will process up to 15 tests on the spot each day without the need for a laboratory.

        What is the Ronapreve? ›

        Ronapreve is the first neutralising antibody medicine specifically designed to treat COVID-19 to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in the UK.

        Is COVID-19 caused by a virus or a bacteria? ›

        The coronavirus disease (COVID-19) is caused by a virus, NOT by bacteria.

        In general, how long do COVID-19 vaccine side effects usually last? ›

        Side effects generally go away in a few days. Even if you dont experience any side effects, your body is building protection against the virus that causes COVID-19. Adverse events (serious health problems) are rare but can cause long-term health problems.

        What are the possible side effects of the BNT162b2 COVID-19 vaccine? ›

        The most common side effects with BNT162b2 (which may affect more than 1 in 10 people) were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain and fever.

        Who are at higher risk of developing serious illness from COVID-19? ›

        Older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness.

        Who might be at higher risk of becoming ill with COVID-19? ›

        People who are at higher risk from COVID-19 and other respiratory infections include: Older people. Those who are pregnant. Those who are unvaccinated. People of any age whose immune system means they are at higher risk of serious illness. People of any age with certain long-term conditions.

        Are smokers at higher risk of developing severe respiratory disease from COVID-19? ›

        The evidence clearly shows COVID-19 virus attacks the respiratory system, which explains why smokers are at greater risk. A small but highly impactful survey from China finds that smokers with COVID-19 are 14 times more likely to develop severe disease.

        What is the best household disinfectant for surfaces during COVID-19? ›

        Regular household cleaning and disinfection products will effectively eliminate the virus from household surfaces. For cleaning and disinfecting households with suspected or confirmed COVID19, surface virucidal disinfectants, such as 0.05% sodium hypochlorite (NaClO) and products based on ethanol (at least 70%), should be used.

        What should I do if I have a positive COVID-19 test? ›

        If you have a positive COVID-19 test result, try to stay at home and avoid contact with other people for 5 days after the day you took your test.

        What nutrition guidance should I follow during the coronavirus disease outbreak? ›

        Proper nutrition and hydration are vital. People who eat a well-balanced diet tend to be healthier with stronger immune systems and lower risk of chronic illnesses and infectious diseases. So you should eat a variety of fresh and unprocessed foods every day to get the vitamins, minerals, dietary fibre, protein and antioxidants your body needs. Drink enough water.

        How can one stay physically active during COVID-19 self-quarantine? ›

        Walk. Even in small spaces, walking around or walking on the spot, can help you remain active. If you have a call, stand or walk around your home while you speak, instead of sitting down.

        How long after receiving the COVID-19 booster are you protected? ›

        Generally, people with healthy immune systems are protected from infection for three to four months after receiving a COVID booster, but protection from severe illness lasts eight months to a year.

        What surfaces should be cleaned during the COVID-19 pandemic? ›

        High-touch surfaces in these non-health care settings should be identified for priority disinfection such as door and window handles, kitchen and food preparation areas, counter tops, bathroom surfaces, toilets and taps, touchscreen personal devices, personal computer keyboards, and work surfaces.

        Can you get the coronavirus disease (COVID-19) from packaging? ›

        The risk of imported food and packaging from affected countries being contaminated with coronavirus is very unlikely. This is because the law requires the exporter to follow the right controls during the packing and shipping process to ensure good hygiene is met.

        Is Pfizer COVID-19 booster safe? ›

        Yes, booster shots are proven to be safe. Pfizer released a study of 10,000 participants in which half of them received a booster dose and half a placebo. In terms of safety, they found no new adverse events, meaning it was consistent with what has been seen in previous studies.

        Can you take ibuprofen if you have the coronavirus disease? ›

        Patients can take paracetamol or ibuprofen when self-medicating for symptoms of COVID-19, such as fever and headache, and should follow NHS advice if they have any questions or if symptoms get worse.

        What should I do if I have COVID-19 vaccine side effects? ›

        Most side effects are mild or moderate and go away within a few days of appearing. If side effects such as pain and/or fever are troublesome, they can be treated by medicines for pain and fever such as paracetamol.

        What is the Yellow Card scheme for the COVID-19 vaccine? ›

        The Yellow Card scheme is a mechanism by which anybody can voluntarily report any suspected adverse reactions or side effects to the vaccine. It is very important to note that a Yellow Card report does not necessarily mean the vaccine caused that reaction or event.

        What is the Ronapreve? ›

        Ronapreve is the first neutralising antibody medicine specifically designed to treat COVID-19 to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in the UK.

        What are the most common adverse reactions to the COVID-19 vaccine? ›

        The most frequent adverse reactions in trials were pain at the injection site, fatigue, headache, myalgia (muscle pains), chills, arthralgia (joint pains), and fever; these were each reported in more than 1 in 10 people.

        Who are at higher risk of developing serious illness from COVID-19? ›

        Older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness.

        Who might be at higher risk of becoming ill with COVID-19? ›

        People who are at higher risk from COVID-19 and other respiratory infections include: Older people. Those who are pregnant. Those who are unvaccinated. People of any age whose immune system means they are at higher risk of serious illness. People of any age with certain long-term conditions.

        Do smokers suffer from worse COVID-19 symptoms? ›

        Early research indicates that, compared to non-smokers, having a history of smoking may substantially increase the chance of adverse health outcomes for COVID-19 patients, including being admitted to intensive care, requiring mechanical ventilation and suffering severe health consequences.

        In general, how long do COVID-19 vaccine side effects usually last? ›

        Side effects generally go away in a few days. Even if you dont experience any side effects, your body is building protection against the virus that causes COVID-19. Adverse events (serious health problems) are rare but can cause long-term health problems.

        Can you take ibuprofen if you have the coronavirus disease? ›

        Patients can take paracetamol or ibuprofen when self-medicating for symptoms of COVID-19, such as fever and headache, and should follow NHS advice if they have any questions or if symptoms get worse.

        What are the possible side effects of the BNT162b2 COVID-19 vaccine? ›

        The most common side effects with BNT162b2 (which may affect more than 1 in 10 people) were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain and fever.

        Videos

        1. Answering your questions about the omicron vaccine rollout
        (ABC Action News)
        2. New Omicron Booster Shots: What You Need to Know
        (Daniela Hernandez | WSJ)
        3. Pfizer and Moderna expected to have upgraded Covid booster shots targeting the Omicron
        (KPIX CBS SF Bay Area)
        4. Moderna testing omicron-specific booster
        (WMUR-TV)
        5. Booster and Omicron: Your questions answered | Ministry of Health NZ
        (Ministry of Health - Manatū Hauora)
        6. What to know about the second COVID-19 booster
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