COVID-19 vaccines look to be on the way, but hurdles remain to end the pandemic

COVID-19 cases are surging again, another round of economic aid is urgently needed and we still haven’t seen each other in months.

At this point, the vaccine can’t come soon enough.

So it was good news last month when a trio of vaccine candidates reported the results of trials that indicated strong efficacy — or effectiveness, in medical speak — and approval for use could be on the horizon:

• A vaccine candidate by pharma giant Pfizer and German biotech company BioNTech reported 95% efficacy in trial and was approved for use in the U.K.
• A vaccine candidate by Cambridge, Massachusetts-based biotech company Moderna showed 94% efficacy in trials, and 100% effectiveness against “severe disease.”
• A third vaccine developed by AstraZeneca and Oxford University showed 70% efficacy overall, including 90% when given as a half-dose and full-dose and 60% for two full doses, with more data likely in late January.

The race is pretty fascinating, like our version of the moonshot playing out in real time. But while we wait for doses to hit the streets, it’s worth taking a step back to remember where we started in this development: Prior to 2020, the previous record for speed in vaccine development was four years, dating to the mumps vaccine in 1967.

So from a science perspective, it’s worth recognizing that, like so many things in 2020, the fact that there are vaccines getting ready for release in a world that barely knew about the coronavirus around this time last year is unprecedented.

Even the experts are marveling.

“It’s just hard to believe that here in December 2020, just about a year after this pandemic was first recognized, we’re talking about the potential availability of vaccines that may protect up to 95% of vaccine recipients being made available in the coming weeks,” said Dr. William Moss, executive director of the International Vaccine Access Center at Johns Hopkins’ Bloomberg School of Public Health. “This is a truly remarkable achievement.”

The quick turnaround was enabled by a few factors, some taking shape in labs over decades and some very specific to 2020. For one, there’s new vaccine technology that has come to the fore in recent years. When most people learned about vaccines, they were described as weakened forms of a disease that train the body to trigger an immune response. But the leading three candidates for COVID-19 take a new approach.

The Pfizer and Moderna vaccines are mRNA vaccines, drawing on technology developed over the last decade, which essentially teach the body to make a protein that can fight the virus. The AstraZeneca version is an adenoviral vector, which is essentially a modified version of a virus that infects chimpanzees, with some of COVID’s “spike protein” added to trigger an immune response. That’s been in development for more than 30 years.

The pandemic situation, as tragic as it is, has allowed for the rapid testing of these vaccines.

Among numerous scientific breakthroughs, both types of new technology can be tested faster than the old attenuated approach, and there are also lots of people to test the vaccines on, given the widespread nature of the coronavirus.

“The pandemic situation, as tragic as it is, has allowed for the rapid testing of these vaccines,” Dr. Moss said.

But don’t start getting the house ready for a big party just yet, as there are many steps left to go before we move out of the pandemic and lots of hurdles. First there’s the formal approval of these vaccines, which could first come when a pair of FDA boards meet to consider the trial results for Pfizer and Moderna in the next couple weeks.

There will still be some things we don’t know, Dr. Moss pointed out. For instance, the long-term side effects from the vaccines are less understood than the long-term side effects. The vaccine’s effectiveness on certain groups, like pregnant women, also still requires more study.

And with these being the first, there could be better options that emerge. The initial two candidates require two doses, which leaves open the potential that people may not come back for a second shot and will make tracking important. From a population level, a single-dose is more ideal, Dr. Moss said. Going forward, there could be others that emerge which are better for specific populations, or can be administered in a single dose. People may even be able to choose. But at least at first, you get what’s given to you.

“We may learn that different types of vaccines are better in some populations,” Dr. Moss said. “I think we’re going to see more tailoring and more choice but it’s going to take us a while to get there.”

The Pfizer and Moderna vaccines also have some caveats when it comes to distribution. For one, they have to stored at very cold temperatures. Pfizer’s needs ultra-low temperatures, so anyone with the vaccine needs “cold chain” storage, while Moderna’s needs to be stored at freezer-like temperatures.

States are really going to have to to take the role with regard to logistics and distribution.

There’s a whole chain of folks involved here who must have storage: not just the companies that transport it from a manufacturing site to the state, but also from the state to the eventual point of distribution. So a vaccine that can be refrigerated would be more ideal.

When it comes to getting the vaccine to the public, it once again falls to that familiar pandemic shot-caller: the state government.

“States are really going to have to to take the role with regard to logistics and distribution,” said Dr. Rupali J. Limaye, a behavioral implementation scientist with the International Vaccine Access Center. “The CDC can provide guidance and feedback on this, but it really is up to the states to determine how this will work.”

With the cold storage needed, that’ll favor sites where there can be a central point for distribution to lots of people.

Then there’s the matter of actually giving people shots.

“The important thing here is vaccines do not save lives, vaccination saves lives,” Dr. Limaye said.

And we’re not all getting the vaccine at once. Instead, it’ll be a tiered approach, with healthcare workers prioritized, along with residents and patients in long-term care facilities. In the D.C.-Maryland-Virginia region, which has a similar plan to many, next up will be essential workers and those who are in the vulnerable group, such as seniors and people with pre-existing conditions. The general public likely wouldn’t start receiving the vaccine until the spring. Children will likely be last, as vaccines are tested in adults first. Dr. Moss is hopeful a vaccine for children over 12 can come by the beginning of the next school year in fall of 2021.

I think in the course of 2021 we will see a more phased return to our pre-pandemic life.

To get the public inoculated, it’s not all in the planning and science. Communication will be an important element. For one, there are folks who don’t trust vaccines.

“I like to think about it as, how do we provide individuals with the facts, but also with the ability to prepare for a vaccine so they are ready,” Dr. Limaye said.

There’s a role to play here for community leaders who are trusted voices in communities and have been providing info throughout the pandemic.

Employers can also create space for vaccines, by giving staff time to get a shot. With more vaccines available, vaccines administered at work also may be an option, Dr. Limaye said.

And there will be need to be continued intention to account for the inequities that have been exposed by the pandemic.

Overall, the experts left the impression that it’s important to remember that where 2020 was a year of quick change, 2021 will be a more gradual process. While the first doses could start appearing mid-December, it’s not like that will end the pandemic all at once. So prepare for a rough winter, with hopes for a better spring.

“These vaccines are not going to be the silver bullet that brings us back to the pre-pandemic period,” Dr. Moss said of the Pfizer and Moderna candidates. Masks, hand washing, social distancing and staying out of crowds will remain the norm. “I think in the course of 2021 we will see a more phased return to our pre-pandemic life.”