Optimizing vaccine development and protection against infection

You can see this peer exchange here.

of Bivalent COVID-19 Vaccine Booster Developed to target the original variants of Omicron and SARS-CoV-2. Vaccine mRNA technology has improved the ability to rapidly modify vaccines to target multiple strains, but minimizing hesitation and maximizing uptake is critical to the safety of these boosters. Education is needed, say panelists who attended a recent conference. Contagion® Peer Exchange Dr. Rodney Rohde will moderate.

booster protection rate

In a study that included data on the bivalent and monovalent COVID-19 boosters from Moderna and Pfizer, the efficacy of the bivalent booster in preventing severe infections leading to hospitalization or death was 61.8% (95% CI, 48.2% -71.8%). 24.9% (95% CI, 1.4 to 42.8) for monovalent boosters administered between 01 September and 8 December 2022 and between 25 May and 31 August 2022.¹ The analysis also found that efficacy peaked at 4 weeks after dosing and then declined.¹

These figures show 94.1% (95% CI, 89.3%-96.8%) and 95% (95% CI, 90.3%-97.6) efficacy of the original COVID-19 vaccine in preventing all grades of infection. lower than the series figures. %) Moderna and Pfizer, respectively.^2,3

But the first tests were done when the virus hadn’t undergone any meaningful mutations, said PharmD’s Jacinda Abdul-Mutakabbir. “The virus is always ahead of us…and we have to take that into account,” she noted. We get there, in terms of keeping people out of hospitals.

The SARS-CoV-2 virus is likely to persist indefinitely, but finding ways to keep up with the latest strains and maximizing vaccine uptake will minimize the virus’ mutation rate. DNP’s Wendy Wright said, “The key point is…[is that] “The longer it stays in your nose and airways, the more likely it is to mutate,” she explained. [effectiveness], we jump for joy. As I tell my patients, her 100% of zero is zero.If it doesn’t arrive [the vaccine], no chance to protect you. ”

As the process becomes more streamlined, the development of updated boosters should also speed up. ‘” Wright pointed out. “I don’t know how long it’s been with Pfizer, but the technology is incredibly exciting. [the vaccine] Dime is really exciting.

Breaking down the “red tape” to enable rapid and safe vaccine deployment, pivoting quickly to adapt to currently dominant strains, and mass producing products is a positive way of dealing with the pandemic. Part of the results, Rohde said, and key steps forward include: Improve vaccine equity and improve manufacturing and supply chain capacity in the United States and globally.

Emergence of variants and booster formulations

Currently available bivalent COVID-19 booster shots targeting SARS-CoV-2 progenitor and Omicron BA.4/BA.5 strains are based on in vitro data and findings from human studies on this strain combination. Approved by Development of a bivalent vaccine targeting ancestral and BA.1 strains.^4,5

This approach could set a precedent for future variant vaccines and reduce the time from development to public release, King said. But Wright said the lack of in vivo data on specific strain combinations has made some patients more hesitant. “Patients were knowledgeable and said, ‘They studied 600 neutralizing antibodies in vitro, but they didn’t test 30,000 people like they did in the original study. She said, “It’s great that we have this technology that can spin on a dime, but people will spin on a dime.” I’m nervous about the technology that can do it, and I’m afraid to put it in my arms.”

Abdul-Mutakabbir said explaining how approved studies on bivalent COVID-19 boosters were conducted could help physicians educate patients about spike protein subvariants and mutations. said. A booster containing her BA.1 strain of ancestry and omicron has been found in human studies to safely produce neutralizing antibodies against variants of ancestry and omicron.^4,5

As Abdul-Mutakabbir told the patient, this study did not specifically test the BA.4/BA.5 strain with currently available bivalent boosters, but among them BA.4/BA. The mRNA for the 5-spike protein is nearly identical. BA.1 of the spike protein.^4,5 “You can really train a scientist’s brain to think about these two issues. [strains],” she said. We don’t have a ton of information, but we do have enough information to ease those fears and allow us to ‘loosen up a little bit’ during the approval process.

Too much information?time to understate

The need to effectively communicate the nuances of the COVID-19 vaccine’s mRNA technology remains an important lesson of the pandemic, Rohde said. (HPV) vaccine, similar to the quadrivalent meningococcal conjugate vaccine, the bivalent COVID-19 vaccine contains different strains of virus. A spectrum of protection.

Unfortunately, discussing the science in detail with patients may make them less likely to get the vaccine, whereas clarity, brevity, and consistency of the message are more likely to encourage uptake of the vaccine. “I’m short and on point. Highly recommended,” said Wright. “The further down the rabbit hole… [the more] people feel like we’re trying to convince them [rather than] I will make a recommendation. ”

Dr. King agreed that “digging deeper” into the science behind vaccines may increase patient hesitation. “It can be scary,” she said. [and] HPV in HPV vaccine. You just say, “This is the pneumonia vaccine and this is the HPV vaccine,” and you don’t mention all the differences, so people don’t think about it. it’s good to be reminded [strains] in them and [COVID-19] Vaccines are something you hear a lot in the news. ”

Rohde added that word choice is important and that clinicians should emphasize that vaccines are designed to challenge the immune system to protect against viruses, not live viruses. rice field. “We are professionals, so if you are strong and positive and use that language with your patients, it goes a long way,” he said. It’s like I’m having surgery, what don’t you want the surgeon to do? I’ve run it 100 times, I’m an expert, beat this and everything will be fine.”

References

1. Lin DY, Xu Y, Gu Y, et al. Efficacy of bivalent boosters against severe omicron infection. N Engl J Med2023;388:764-766. doi:10.1056/NEJMc2215471

2. Baden LR, El Sahly HM, Essink B, etc. COVE study group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med2021;384(5):403-416. Doi: 10.1056/NEJMoa2035389

3. Pollack FP, Thomas SJ, Kitchen N, et al. C4591001 Clinical Trial Group. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med2020;383(27):2603-2615. doi:10.1056/NEJ Moa2034577

4. Chalkias S, Harper C, Vrbicky K, et al. Bivalent omicron-containing booster vaccine against Covid-19. N Engl J Med2022;387(14):1279-1291. doi:10.1056/NEJ Moa2208343

5. Winokur P, Gayed J, Fitz-Patrick D, etc. C4591031 clinical trial group. A bivalent Omicron BA.1-indicated BNT162b2 booster in adults 55 years and older. N Engl J Med2023;388(3):214-227. doi:10.1056/NEJ Moa2213082