2022년 9월 6일 화요일

Bivalent COVID-19 Vaccine Booster Shots Approved by FDA



 What is a bivalent COVID-19 booster vaccine?

업데이트된 COVID-19 백신 부스터에는 원래 바이러스 변종과 오미크론 변종의 성분이 포함되어 있습니다. 이것은a bivalent COVID-19 vaccine. 이라고 불린다. 업데이트된 COVID-19 백신 부스터는 오미크론 변종에 대한 더 나은 보호를 포함하여 COVID-19에 대한 광범위한 보호를 제공하도록 설계되었습니다.

Did CDC approve new booster?

2022년 9월 1일 -- CDC는 오늘 오미크론과 코로나바이러스의 오래된 변종 모두를 대상으로 설계된 백신 사용을 승인했는데, 이는 겨울이 미국에 도착하기 전에 광범위한 예방 접종 캠페인의 목표를 도울 수 있는 조치이다

The older you are, the more important it is to get a fourth shot, said Dr. Peter Chin-Hong, an infectious disease specialist at the University of California, San Francisco
8월 15일, 영국은 원래의 코로나 바이러스 외에도 오미크론 변종을 목표로 설계된 부스터 백신을 승인한 첫 번째 국가가 되었다. 새로운 백신은 두 가지 종류가 있는데, 이것은 두 가지 변종 바이러스와 싸울 것이라는 것을 의미한다.

비슷한 부스터가 곧 미국에도 올 것이다.(영국이 승인한 이 주사제는 지난 겨울 감염 사례가 급증한 오미크론의 첫 번째 변종으로부터 보호하기 위한 것인데, 미국은 현재 지배적인 바이러스 버전인 BA.5를 구체적으로 표적으로 삼을 수 있는 백신을 기다리고 있다.) 바이든 행정부는 노동절 직후 이러한 개편된 백신을 12세 이상의 사람들에게 배포할 계획이다.

새로운 부스터 샷이 곧 나오면서, 의사들과 전염병 전문가들은 사람들이 지금 네 번째 주사를 맞아야 하는지 아니면 오미크론 특유의 부스터 주사를 기다려야 하는지에 대한 질문을 던지고 있다고 말했다.

네 번째 샷을 사용할 수 있는 경우:
CDC는 사람들이 자격이 되는 즉시 부스터 주사를 맞을 것을 권고한다. 현재 50세 이상 성인, 12세 이상 면역력이 약한 모든 사람이 4차 접종을 받을 수 있다.

전문가들은 지금 부스터샷을 찍을 자격이 있는 사람들이 받아야 한다고 입을 모았다. 나이가 들수록 네 번째 주사를 맞는 것이 더 중요하다고 샌프란시스코 캘리포니아 대학의 전염병 전문가인 피터 친-홍 박사는 말했다.

COVID-19’s bivalent boosters: 10 questions, answered

BY CYNTHIA DEMARCO

You may have heard that the Food and Drug Administration (FDA) has granted emergency use authorization to a new pair of COVID-19 booster shots. These updated vaccines are designed to help protect people from the most prevalent subvariants of the current strain: Omicron BA.4 and BA.5.

To learn more about these vaccines, including how they differ from previous COVID-19 booster shots, who is eligible to receive them, and when to schedule them in relation to your flu shot, we checked in with infectious diseases specialist and head of Internal Medicine David Tweardy, M.D.

What are these new COVID-19 boosters, and how do they differ from the existing ones?

Until now, COVID-19 booster shots have been monovalent or univalent. That means they only contained one version of the mRNA sequence for the SARS-CoV-2 virus’ spike protein — the one that came from the original strain which emerged in late 2019 in Wuhan, China.

The boosters that just got approved are considered bivalent vaccines. That means they contain the mRNA sequence for the spike protein of two strains of SARS-CoV-2:

  1. the original strain from Wuhan, and
  2. the current predominant subvariant of Omicron, BA.5.

The spike protein on the surface of both Omicron’s BA.4 and BA.5 subvariants is exactly the same. So, this booster should protect people against both.

Who is eligible for a bivalent COVID-19 booster shot?

The two vaccines have different age restrictions.

  • Moderna: 18 years and older
  • Pfizer: 12 years and older

You only need a single booster shot of the bivalent vaccine to be considered fully boosted, but you’re not eligible to get it unless you’ve already been fully vaccinated with either Johnson & Johnson/Janssen’s original one-shot regimen, or Pfizer or Moderna’s original two-shot regimen.

You’re eligible to get a bivalent booster shot two months after you’ve been fully vaccinated.

Can I get a bivalent booster now, if I just recently got my second univalent booster?

No. You’ll need to wait until two months have passed since your last booster shot.

But don’t kick yourself, even if you just got one and now wish you’d waited. The entire point of getting a booster shot is to continue expanding your protection. So, the more boosters you get, the better protection you’ll have.

That’s why I would get a bivalent booster shot as soon as I was eligible.

How long do I need to wait to get the bivalent booster if I’ve had COVID-19?

If you were very ill, you’ll need to wait at least until the worst of your symptoms have resolved, and you have met the criteria to leave isolation. Patients with recent COVID-19 infections also have the option of waiting three months instead of two (counting from the time they first showed symptoms or tested positive) to get a booster shot.

Talk with your doctor to determine the best timing for you to get one if you have any questions.

Are there any special considerations around scheduling, given that it's also time for flu vaccines?

No. The Centers for Disease Control and Prevention (CDC) say there’s still no need to stagger your vaccinations. So, if you’re due for both, you can get your flu shot and your COVID-19 booster at the same time on the same day. You can even get them in the same arm, if you want to cut down on the amount of soreness you experience.

Is there any reason not to mix and match boosters, by getting your bivalent from a different manufacturer than you did the first time?

No. It’s OK to mix and match as long as you’re eligible for the vaccine you prefer.

All of the data that previously showed there were no big differences between those who mixed and matched and those who didn’t still applies. I haven’t seen anything to even imply that anything’s changed.

What about immunocompromised patients? Any special rules for them?

No.

In fact, I am really excited about this latest development, because it could end up being a real game-changer for our immunocompromised patients.

It’s already becoming increasingly rare to die or become really ill from COVID-19. But this bivalent vaccine is another step in the march toward a more endemic stage.

The infrastructure is already in place to make massive quantities of vaccine in a very short time. So, anything after BA.5 could theoretically be added to the composition of the next booster. I think COVID-19 boosters will probably be multivalent from here on out, just like with the flu. And for patients who haven’t been able to mount a sufficient defense against COVID yet, maybe repeated boosters will finally allow them to get there.

Can I get the bivalent booster if I regularly receive EVUSHELD injections to protect myself from COVID-19?

Yes. Those who take EVUSHELD antibody therapy to protect themselves from severe COVID-19 infection can receive the bivalent booster, if eligible. Those who receive a vaccine dose (primary or booster) should wait at least two weeks before getting the EVUSHELD injection, according to the Centers for Disease Control and Prevention’s advisory group.

When might the bivalent boosters be offered to children under 12?

My guess is within three to six months. But it could be faster. Manufacturers are using the exact same processes to make the bivalent boosters as they did to make the originals. So, while the change in proteins included is an important one, it’s still relatively small from the point of view of the body’s developing a new adverse reaction to it. 

I wouldn’t be surprised if the safety and efficacy studies in children under 12 from the original vaccine led to emergency use authorization a bit more quickly with this one than they did with the original. The volume of safety data we have now for the original vaccine may give reviewers more confidence about the safety of the bivalent vaccine, which was generated using the exact same process as the one for the original vaccine.

Where can I find a bivalent COVID-19 booster?

Once bivalent COVID-19 boosters become available, you should be able to obtain one anywhere you’d normally get a COVID-19 vaccination or flu shot.

Will I be able to get the bivalent booster at MD Anderson?

We expect to get bivalent boosters soon. When we do get them, they will only be available for MD Anderson patients and employees. Patients will be able to schedule a booster appointment via MyChart.



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