Thread by @LizSzabo

@DrPaulOffit tells @JAMA_current he was totally surprised that both mRNA vaccines have 94-95% efficacy. In January, he said, "no one would have thought this was possible."
#JAMAlive

In his live interview, @JAMA_current debunks some myths about covid-19 vaccines that are really important. A doctor friend texted me and wanted me to ask @drpauloffit about it for her! Instead, read this slide.

LIVE: @drpauloffit tells @JAMA_current that it's extremely encouraging that both mRNA vaccine got the same results, even though they use different doses and have other technical differences in the way they're put together. #CovidVaccine

LIVE: @drpauloffit tells @JAMA_current that both mRNA vaccine have "essentially the same results across the board...
It’s exactly what you want to see." It's reassuring that vaccines put together very differently act the same. Validates the strategy.

LIVE: @drpauloffit tells @JAMA_current he has two potential concerns about @pfizer and @modernatx vaccines. Although they had 94-95% efficacy, this was measured right after ppl got the second dose, when immune response is strongest. Protection could decline as time goes by. 1/2

Second concern for mRNA vaccines from @drpauloffit. Incidence of covid-19 in placebo group was 0.7/0.85%. That's much lower than expected rate of 3-3.5%, suggests volunteers were very careful to avoid disease. In real world, ppl might be exposed to higher viral loads #JAMAlive

Really interesting point here: Clinical trials are often the best-case scenario for a drug. For example, cancer drugs have been shown to work much better in carefully controlled trials, where patients tend to be healthier, younger than general population. #jamalive

So @modernatx, @pfizer vaccine efficacy could be "best-case scenarios." In real world, ppl may get exposed to much higher levels of virus than the extremely careful volunteers in the study (1/4 of whom were health providers). Vaccine may not work as well against high viral load.

Will covid-19 vaccines protect elderly, people w/ obesity, chronic conditions? @Drpauloffit tells @JAMA_current says that data is in @pfizer's FDA application, but b/c he's a member of FDA committee, he can't talk about it until 12/10 public meeting. Data will be public 12/8.

Does the UK's approval of @Pfizer vaccine put pressure on @FDAgov or its advisory committee to speed approval of a US vax? @DrPaulOffit says no. Waiting a week for approval is not the issue; "the hard part is going to be getting it out there... into people's arms." #jamalive

"You don't want to go too fast." @DrPaulOffit says @fdagov needs time to read all the data. When applied for rotavirus vaccine approval, the papers piled up "would have exceeded the height of the Sears tower."

Howard Bauchner said most people will believe the vaccine works. But they worry about safety. @DrPaulOffit said that we know that within 2 months, there were no rare serious events when tested in 10s of 1000s of people.

"If you have a serious side effect, you will find it out pretty quickly," or within 2 months, said @drpauloffit. That's why @fdagov required vaccine makers to follow patients for 2 months. #jamalive

"Safety is the number one thing people are worried about. Most people getting these vaccines will be healthy young people who are unlikely to die from this virus." By young, he probably means "under 65." ;--) #covid

@drpauloffit: Vaccines can cause rare but serious adverse events. One in 1 million ppl who get flu vaccine get Guillain-Barre syndrome, a paralysis that is usually reversible. But that tends to happen w/in 6 weeks of getting vaccine. We haven't seen that with covid-19 vaccines,

@DrPaulOffit notes that 1 in 1 million ppl vaccinated against yellow fever can actually develop yellow fever. (But that's why docs only recommend yellow fever vaccine to people at high risk. In this population, vaccine helps way many, many ppl than it harms.) #jamalive

@DrPaulOffit on safety of covid-19 vaccines, which have been tested in tens of thousands of ppl. "20,000 people is not 20 million people and you will only find rare adverse events after approval. That's definitely true. That's always true."

@DrPaulOffit tells #jamalive: While all drugs/vaccines have risks, "The choice not to take a vaccine is not a risk-free choice. It's just a different risk."

@DrPaulOffit tells #jamalive: Covid-19 vaccines use mRNA to stimulate immune system. What turns the mRNA off? And when? Looking at animals, it happens for 10 days, he says.

From #jamalive. How do covid-19 vaccines work?

@DrPaulOffit notes that we've never had a commercially available mRNA vaccine before, which makes him "more concerned." The vaccines include "naked" mRNA in a complex lipid delivery system (a fat bubble?). Without that fatty coating, immune system would "eat it up."

Dr. Howard Bauchner: "There’s no such thing as absolute safety" for vaccines. "If we get to January or February and we are at 200k to 300k cases a day, and 3000-4000 deaths a day, that changes the equation for every single individual." #jamalive

Dr. Howard Bauchner asks @Drpauloffit about safety of covid-19 vaccines for kids, pregnant women, those w. autoimmune disease. @ModernaTx announced today that it will test vax in 3000 kids 12-17 in rigorous trial.1/3

@DrPaulOffit notes that although vaccine trials didn't recruit pregnant women, every trial inevitably ends up including women who get pregnant during trial or didn't know they were pregnant. So there will be some data on pregnant women. 2/3

Will covid vaccine be safe in pregnant women or autoimmune disease? @cdcgov has a program called VSAFE that will follow patients with these and other conditions, said @DrPaulOffit. 3/3 #jamalive

@DrPaulOffit: Tens of millions of health care personnel and nursing home residents will get covid-19 vaccines first, before general public. So there will be tons of safety/efficacy data before the general public is eligible for vaccine. #jamalive

Should people who've had covid-19 get vaccinated? @pfizer didn't exclude people who had covid antibodies in the trial, so we will know the safety in those groups, @drpauloffit says.

"You can't mandate a vaccine that is such a novel strategy. Let a few million people be vaccinated... Let that happen and then we can talk about mandates," says @DrPaulOffit.

When can we be sure that covid-19 vaccines are safe? @DrPaulOffit says, "Dr. Maurice Hilleman, whom I consider the the father of modern vaccines, said, 'I never breathe a sigh of relief until the first 3 million doses are out there.'"

@DrPaulOffit: Once vaccines are used by older people, who tend to get sick and have health problems, it's inevitable that someone will get a shot and then have a heart attack. Will need to quickly compare rates among vaccinated/non-vaccinated ppl to know if vaccines are cause.

@DrPaulOffit: An advantage of mRNA vaccines is that they can be manufactured much, much faster than traditional vaccines. Companies should easily be able to make 7 billion doses (enough for entire world) within 2 years. #jamalive

Best quote of the day: @DrPaulOffit says the scarcity of covid-19 vaccines in Jan-Feb will increase demand. "This to me will be the Beanie Baby phenomenon."

@DrPaulOffit: If you can vaccinate 5 million vaccines a week, that's 100 million people in 20 weeks. That's 5 months, which covers the first phase of vaccination (health personnel and nursing home residents).

When can average person expect to get a vaccine? @DrPaulOffit predicts it will take until late summer or fall to have 300 million doses for all Americans. #jamalive

Dr. Howard Bauchner notes that 10-20% of ppl who are vaccinated have some sort of non-serious reaction, but feel rotten. How do we educate people about this? #jamalive @khnews tackled this here, khn.org/news/article/t…

@DrPaulOffit: "I wish the immune system had a better public relations team" to tell ppl vaccines that induce immune response, which can cause headache, muscle ache, fatigue bad enough to miss a day of work. "This is just a natural reaction to having an activated immune system."

Because covid-19 vaccines may cause "mild" side effects (but bad enough to make you miss a day of work), @DrPaulOffit notes that hospitals shouldn't vaccine entire ER staff at once, or many could be out sick the next day and unable to work. #jamalive

How long could immunity from vaccine last? We don't know, said @Drpauloffit. But in general, coronaviruses induce immunity for only a few years; people who get natural disease again may get mild disease but not die or be hospitalized. Vaccines may provide similar protection.

@DrPaulOffit: He said he wants @Pfizer to tell him if vaccinated people have high levels of memory T-cells and B-cells, which protect you against getting severe disease. "We want to keep people out of the morgue." #jamalive

@DrPaulOffit predicts that novel coronavirus will not mutate so much that we'd need new vaccines every year like flu. "People say flu mutates from year to year. No, flu mutates from minute to minute." #jamalive

@drpauloffit: The good news/bad news of 2020. "I've never been busier." Now that he doesn't travel to conferences, "I can give three talks in one day."

- 30 -