The COVID vaccine is undergoing an upgrade. Should your vax status also get one?
For two years, we have been protecting ourselves with a vaccine modeled on the original version of the virus. But shortly after Labor Day, a new booster — call it Vaccine 2.0 — will be available to all adults in the United States.
The current vaccine still prevents serious illness and hospitalization, scientists say, but its potency is declining. It is feared that this will worsen the pandemic this fall and winter.
Because the virus has mutated, “we have been waiting a long time”, according to Dr. Eric Topol, founder and director of the Scripps Research Translational Institute in San Diego. “The FDA should be commended for wanting to take an aggressive and quick approach.”
But there are some uncertainties about the effectiveness of this updated vaccine. Although the new booster has proven to be safe, efficacy studies have so far only been performed in mice.
Should we hurry to get it? Here are some things to consider before you decide.
Q: How is it different?
One part targets the spike protein on the original Wuhan strain of the virus, just like the original vaccine. But it also has a second part, which targets a new mutated form of the spike protein, found in the BA.4 and BA.5 variants. that circulate today. These variants have been shown to be more adept at dodging our immune protection.
Bivalent vaccines are not a new concept. Vaccines against other diseases also target ancestral and mutated strains of a pathogen. For example, the flu vaccine is designed to protect against four different flu viruses. The HPV vaccine targets nine strains of the papillomavirus. The pneumococcal vaccine targets 23 different strains of Streptococcus bacteria.
Q: When will it be available?
A: Last Monday, Pfizer and Moderna submitted their data to the FDA for emergency use authorization. The next day, the Biden administration said so plans to roll out the vaccine in September.
Although the exact timing has not been announced, a panel from the US Centers for Disease Control will discuss the rollout next Thursday and Friday. Then things will move quickly: CDC Director Dr. Rochelle Walensky typically adopts the panel’s recommendation within hours, followed soon after by an advisory group from Western states and California health officials.
If things go according to plan, the shot could be ready shortly after Labor Day.
Q: Should you get it?
A: In general, if you haven’t had a vaccine or recovered from a COVID infection in the past six months, getting a booster is a good idea, experts say.
Your immune response to a vaccine begins to wane after two months, although some protection persists four to five months later. So if your last hit was in February or March, you’ll be due.
The other thing to consider is that the last time you were bitten was with a vaccine that offered no special protection against the now prevalent omicron strain.
“It’s going to be really important for people this fall and winter to get the new vaccine. It’s designed for the virus that’s out there,” White House COVID response coordinator Dr. Ashish Jha told a virtual event hosted by the US Chamber of Commerce Foundation last week.
Q: Who is eligible?
A: According to the CDConly people who have already completed their two “primary series” COVID injections will be eligible for the new bivalent booster.
Pfizer’s bivalent booster is designed for teens and people 12 and older, while Moderna’s is for adults 18 and older.
Q: You are vaccinated and boosted, but you had COVID a month ago. Should you still get the new booster?
A: Finally, yes. But not right now.
“Wait. The immune system was just ‘super boosted’ with the infection and it’s still being treated and ‘learning’,” tweeted immunologist Dr Michael Mina, formerly of the School of Public Health at Harvard and now at eMed.
I was in this situation. Was about to be boosted. I had COVID. Turn off the booster
I also monitored my antibody levels after infection. We don’t have great correlates of protection, but I take a more data-driven approach when boosted – not just “x months”
—Michael Mina (@michaelmina_lab) August 16, 2022
Q: Why is this booster deployed, if it has not yet been proven in humans?
A: The FDA says the injections are safe and will help ward off the disease. “How confident am I?” Dr. Peter Marks, the lead FDA vaccine regulator, said in an interview with the New York Times. “I am extremely confident.”
In preclinical data presented by Pfizer and Moderna to the FDA in June, the bivalent vaccine design appeared to work better than the single-target vaccine.
In eight mice, Pfizer’s bivalent boost generated a 2.6-fold increase in levels of neutralizing antibodies against the BA.4 and BA.5 subvariants, compared to the companies’ current boost. Moderna’s lab work showed that its new booster increased neutralizing antibodies against the new variants 8-fold, while the original booster only increased antibody levels by about 4.4-fold.
The companies are currently conducting clinical studies in humans. But those results probably won’t be ready until late October or early November.
Q: Is the urgency to deploy the new vaccine a first?
A: There is precedent for this approach. The annual flu vaccination schedule, for example, is updated using mouse data only.
Some scientists, such as Topol and Dr. Paul Offit of the University of Pennsylvania, say that’s not enough. They say the new COVID booster may not work as well as the mouse data suggests – and want proof that it offers significant clinical improvement over the current booster.
“We will know a lot more about bivalent booster in the weeks after the program launches,” Topol said. While people are quite likely to benefit from the new booster, he said: “I’ll wait to see some data before I get it. Maybe I’m a little too conservative, maybe too data driven for my own good.
But others say there is enough experience with previous vaccines to be sure the vaccine is safe. The antibody data suggests it works, they add. And they worry about the increasing risks of illness this winter.
Dr. Bob Wachter, who chairs the department of medicine at UC San Francisco, isn’t waiting.
“I’ll take mine as soon as I’m eligible,” he said. tweeted.
Credit where credit is due (Biden administration, @FDAand @pfizer & @moderna_tx):
A few months ago I was skeptical that we would have the new bivalent booster by September, but it looks like we will. I’ll take mine as soon as I’m eligible. https://t.co/f3LyLmaF6W
— Bob Wachter (@Bob_Wachter) August 24, 2022