Today, the FDA will meet to discuss boosters. (You can watch the LOOONNGGG meeting here if you want. I will also give an update after the meeting if you don’t have 8ish hours to watch an FDA meeting. #lotsofcoffee.)
As you know by now from the news, the issue of boosters is a mixed bag. Who should get them? When should people get them and does that depend on the person’s age, underlying conditions, etc? That will all be debated today. Here’s what to expect:
As a reminder, the Vaccines and Related Biological Products Advisory Committee, the independent panel of 20 scientific advisors, will meet to review information from Pfizer’s vaccine.
They will look at data regarding potential declining protection over time (and when does that decline matter the most, if at all), how people tolerated booster doses (side effects, etc), and if certain subgroups benefited the most from a booster.
The panel will specifically look at data from Israel, which is actively rolling out boosters amid Delta, data from the UK, and a bit from the US that suggested waning protection from 2 doses and waning effectiveness against Delta. (Side note: The US data included 300 people in Pfizer’s clinical trial who received the 3rd dose and showed a big bump in neutralizing antibodies against COVID. Those antibodies are really important protection mechanisms for our bodies.)
With all vaccines, we will also see safety and effectiveness data from boosters. I’m curious to see the data on different booster doses. Do we need a lower dose than the initial 2 doses? The data should answer that today.
As a reminder, boosters are already approved for immunocompromised 12 years+ people at 8 months post your 2nd mRNA vaccine.
The other thing I’m listening for today is a discussion about vaccine equity.
You may have heard in the news that Dr. Tedros Adhanom Ghebreyesus, Director of the WHO, has called for a halt on vaccines boosters until at least the end of September. This isn’t the first time he has called on nations to share supply. The rationale was the continued extreme gap between vaccinations in high-income and low-income countries. In high-income countries, vaccines are 50 doses for every 100 people. In low-income countries, vaccines are 1.5 doses for every 100 people. (Data source)
The major risk we run if we do not vaccinate the world is variants that evade our vaccines. The more time COVID can circulate with highly transmissible variants like Delta in low-vaccinated areas, the more time COVID can mutate. It’s still a race between vaccine and variants.
If we look at specific countries, notice countries like Tanzania haven’t even received 1 million doses yet - but, has a population of 56 million. In contrast, the US has received 210 million doses with a population of 324 million. Look at the below figure to see the share of the population vaccinated in selected countries. For places like Peru which has one of the highest infection and mortality rates from COVID in the world, vaccinations are barely 37%. Look at Afghanistan, Somalia, and Tanzania. Then compare that to high-income countries.
In his statement, Dr. Tedros said:
So far, more than 4 billion vaccine doses have been administered globally. More than 80% have gone to high- and upper-middle income countries, even though they account for less than half of the world’s population. I understand the concern of all governments to protect their people from the Delta variant. But we cannot accept countries that have already used most of the global supply of vaccines using even more of it, while the world’s most vulnerable people remain unprotected. In late May, I called for global support for a “sprint to September”, to enable every country to vaccinate at least 10% of its population by the end of September. We’re now more than halfway to that target date, but we’re not on track. We need an urgent reversal, from the majority of vaccines going to high-income countries, to the majority going to low-income countries.”
The gap between high-income and low-income country vaccination rates is one of supply. So, do we use the supply in high-income countries for people who have already been fully vaccinated and still remain largely protected against severe disease and death? Or do we use the supply to vaccinate people in low-income countries to close the gap and protect all of us from highly transmissible variants like Delta and potential new variants that evade our current vaccines? Can we do both given the current supply? I don’t know and so far we haven’t done both. Don’t get me wrong - I want my family who might be at risk for waning immunity given their age to remain protected. I also want my colleagues in friends in Somaliland who can’t get even a first dose to be protected.
This debate should be a both/and rather than either/or. In the coming days, I think we will continue to hear an individualistic versus collectivist argument for boosters. Little by little through the pandemic, I’m hoping that the individualistic world views of high-income countries will be chipped away towards more of a collective identity of love-for-neighbor. We shall see.
I hope this helps broaden our booster discussion to the globe, not just high-income settings. Let me leave you with a powerful story Dr. Tedros shared in his media briefing to urge for vaccine equity. Stay tuned for the FDA summary later.
“Good morning, good afternoon and good evening.
In January of this year, a midwife from Uganda called Harriet Nayiga joined our press conference to talk about her experience as a health worker during the pandemic. While vaccines were being rolled out in the wealthiest countries, Harriet was one of many health workers in Africa and around the world who was still waiting for her turn to be vaccinated.
At the time, Uganda – like much of Africa – had relatively few cases of COVID-19. But starting in May of this year, Uganda experienced a surge in cases and deaths, as variants tore through a largely unvaccinated population.
This morning, Harriet sent us this email:
“I got my first shot and am yet to receive the second.
“The situation was tough for the last two months, where over 2000 people died so far, including health workers.
“We hope that the vaccines will be able to reach different parts of the country and hope that people will be responsible enough and go for vaccination.
“Otherwise, COVID is spreading, though people are now moving to work in order to earn a living, since the majority depend on hand to mouth.”
This is the reality for hundreds of millions of people around the world – they cannot afford to stay at home. They work to eat.”
-FNE
What about boosters?
Great post. xo, Lindsey
Thanks Emily! I have relatives who are waiting for the Novavax vaccine - any chance you have information on when it might be available AND it's safety/efficacy data?