Composition of next COVID boosters raises questions
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The FDA guidance on updating the next COVID-19 shots for the fall booster campaign has prompted some experts to doubt their likely immune response, while some even question the need for such boosters as the virus evolves.
In June, the FDA advised vaccine developers to update their next generation of COVID-19 vaccines to reflect Omicron BA.4 and BA.5 subvariants ahead of a booster rollout expected in the fall.
The decision follows a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), in which a group of independent experts of the agency voted 19-2 to recommend the addition of an Omicron component for the vaccines.
Vaccine makers Pfizer (NYSE:PFE)/BioNTech (BNTX), Moderna (MRNA), and Novavax (NVAX), all of which have already developed bivalent vaccine candidates using the original Omicron variant, BA.1, made presentations during the meeting.
However, outcompeting the BA.1, more transmissible BA.4 and BA.5 versions of the virus have become dominant in the U.S., according to the estimates from the Centers for Disease Control and Prevention (CDC) for late June.
Both Pfizer (PFE)/BioNTech (BNTX) and Moderna (MRNA) have already disclosed clinical data for their BA.1-adjusted bivalent vaccine candidates, albeit with lower antibody response against BA.4 and BA.5 subvariants of the Omicron.
That data readout has prompted Paul Offit, MD, a VRBPAC member who voted against the recommendation, to argue that the vaccine candidates updated for BA.4 and BA.5 might not generate the same level of immune response as the BA.1 bivalent vaccines triggered.
“It is not reasonable to assume that data generated for an Omicron BA.1 vaccine can easily be extrapolated to BA.4 and BA.5,” medical journal JAMA reported quoting Offit, who also serves as the chair of vaccinology at the University of Pennsylvania’s Perelman School of Medicine.
“These new Omicron subvariants are highly transmissible. Therefore, they will require a very high level of neutralizing antibodies present at the time of exposure to prevent symptomatic infection,” Offit argued.
Noting the evolving nature of the pandemic, the FDA said in its advice that it would ask manufacturers to start clinical studies for the shots updated for BA.4 and BA.5 subvariants.
The sceptics of Omicron boosters include Peter Hotez, MD, Ph.D., the dean of the National School of Tropical Medicine at Baylor College of Medicine, and co-director of the Texas Children’s Hospital Center for Vaccine Development.
“I might have also voted against it, but for a different issue: My objection is there’s just a lot of muddled thinking about what’s coming up in the fall,” remarked Hotez, who is not a VRBPAC member.
‘’We’re not trying to match what may circulate. We’re trying to increase the breadth of the immune response,” Hotez added, arguing that the Omicron variant could be in the rearview mirror by fall.
Notably, the European Medicines Agency (EMA) said last week it would consider COVID-19 vaccines adapted to past subvariants of Omicron this fall despite the rising prevalence of newer subvariants. How quickly manufacturers can update vaccines for BA.4 and BA.5 is also a consideration, noted Marco Cavaleri, EMA's head of health threats and vaccines strategy.
"That's why for the time being we still think that it's very good to keep all options open and to not exclude any of these candidates from any potential approval," he added.
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If you want... sure!It's not compulsory. No more than the Flu shot is compulsory.One more thing... why are all you people commenting here?This site is for investors. If you were invested in biotechs, I'd expect you to know a little more about the subject.





2) kept body hydrated,
3) generous amount of eggs, seafood, etc,
4) absolutely NO soft drinks and sweets, occasional fasting,
5) sun ray exposing (<20 minutes per day) but not sunbathing (>1-2 hrs per exposure),
6) if not enough good quality food, sleep, sun exposing; consider taking supplements. Vitamin D3 is extremely vital to defense of all kinds of viruses and bacteria. Melatonin is a powerful anti-oxidant that regulates sleep.
7) regular exericseDon't fool yourself on why the American population is so dependent on medical systems on their chronic diseases, e.g. Diabetes, Hypertension etc, many a case, they are preventable and reversible. It depends on whether the person is willing or not to revert to a healthy lifestyle.Vaccine, as far as I know, is protective once it is administered. I do not consider the present injections as "vaccines". Poor in effectiveness (still able to contract the disease even triple "vaccinated") and poor in side effects manifestation (other than the proven myocarditis, there are unofficial reports of increasing oncological flare-up, vascular complications, auto-immune disease complications etc).I am crystal clear on the bet on this manufactured virus. p.s. has been not using face covering for half year visiting regularly (3-4 days/week to supermarkets and malls etc. No signs and symptoms of infection.
exactly. when someone contracts covid and dies, they like to say most of them are not vaccinated. it is also true many of them did not get the shot because they have some underlying diseases making them ineligible for the shot. so if someone has underlying disease, and he doesn't get the shot, or he get the shot anyway, but he dies...does that mean he dies because he doesn't get the shot, he has underlying disease, or he is part of the unlucky statistics who is going to die anyway? and for those get the shot and don't die, are they supposed to recover anyway because most of us don't die of covid. i don't know, need truthful answer.

ONLY IT HAS NOT WORKED.
They are going ahead with something they ADMIT does not work, and the FDA is just waving them on like a bunch of blind idiots.
I can think of no prior example in human history of such idiocy.

That’s all good and some of it is true until some disaster natural or man-made comes along and people ask what the government is doing. If this was Ebola, there would be panic in the streets to get a cure. Not quite that bad but millions have died and until it happens in your family as mine, it’s easy to say everyone just do their thing. What happen to sense of community not dictated by anyone, just because we respect the well-being of one another? Not saying everyone should get vaccinated but more steps should be taken to stop the spread. The longer it mutates, the greater we will have something we can’t stop. I am always wary of any absolutes that paint one approach for all situations and way of life. Just an example of free thought. No need to respond, sorry most go to spam.







www.youtube.com/...Other experts spoke positively about the Novavax vaccine and data during the meeting. To see the information, we recommend watching Novavax's presentation to the expert committee and the positive discussion that follows. Here is a link to a copy of the YouTube live stream of the meeting cued up to the exact start of the Novavax presentation: youtu.be/...Please note that only some of the discussion and comments about Novavax came just after the presentation., which was in the morning. A lot of it came later in the day. If you are a Novavax investor or thinking of becoming one, or are simply interested in vaccines or what's going on in the fight against Covid, the presentation is very worth seeing. Also, if you are ever going to forward a Novavax newsletter to friends, family or colleagues, today's newsletter is probably the one you should because the information above is seminal for both the company and the fight against Covid. The side effects data in the next story below is also important for the company and the general public, who prefer lower side effects.Register for free here: novavaxinformation.com/...end of excerpt

>> atrial fibrillation, palpitations, flutter, murmur, pacemaker
>> added, fluid in heart, abnormal echocardiogram including:>> 3,105 Heart attack or cardiac arrest, sudden loss of blood
>> flow from failure to pump to heart effectively, cardiac failure,
>> disorderAll the more important to take a hard stand against this madness as the vaccine zealots target children under age 5.What's also clear is that the system has lost its mind. The Emergency Use Authorization should only be in place if there are no alternative treatments (which is why the effective alternative treatments got surpressed).There is no vaccine that would ever be approved under a fair trial if the placebo group was treated with the now understood to be effective proper protocols. Doctors across the land are effectively treating Covid. No one is dying who get the proper (early) treatments.The argument that the vaccine is needed to lessen severity is bogus.

