Of course the most exciting news for most people as far as vaccines go is that the Pfizer vaccine should be getting an expansion of it’s Emergency Use Authorization to includ 12-15 year olds this week, that Pfizer is filing for full FDA approval of its vaccine, and finally that Pfizer expects to expand their approval to 2-11 year olds in September. EDIT: Not long after I posted this story, the news hit that the FDA today expanded the EUA to include 12-15 year olds! Get those kiddos vaccinated, folks!
Whew! A lot going on in that sentence, but it’s all amazingly important, so I wanted to get it out there ASAP.
But enough about Pfizer. Did you know that there are at least 251 COVID vaccines still currently in development? Or that at least 60 of them are far enough along their development that they are in some stage of human trials?
That’s on top of the 14 vaccines that are currently in use worldwide.
So, why are companies trying to develop more vaccines, when we already have 14 of them in use? Especially when we have vaccines like the Pfizer and Moderna vaccines here in the US that are proving to have such excellent effectiveness?
Well, for one, we have billions of people to vaccinate worldwide. That’s a lot of people to vaccinate, and we need as many arrows in our quiver as possible to meet that kind of urgent demand.
For another, a vaccine that works for one country or region might meet with problems in others. There are storage and temperature concerns with Moderna and Pfizer, for example, that make it more difficult to deliver in remote areas that won’t have the kind of storage facilities needed. And Moderna and Pfizer are both 2-dose regimens. A one-and-done vaccine (like the Johnson & Johnson vaccine) is easier because of course then you don’t have to worry about your target population getting access to their second dose. And of course then there are concerns about COVID variants and having vaccines that will work on those. And, finally...well, even with so many vaccine projects in the works, a given vaccine product can fail at any stage of the approval process, so out of those many vaccines in development, some, perhaps even many, will undoubtedly “wash out” of the development process at various stages, for various reason.
So, let’s take a look at a few of the vaccines in development. There’s some exciting stuff in the works.
Novavax
Novavax is expected to be applying for an EUA just about any time from the FDA here in the US. Update as I was writing this diary — Citing difficulties in collating and preparing its data for submission to the US and UK, Novavax has now announced they are pushing back approval expectations until 3rd quarter of this year. The Novavax vaccine is a 2-shot regimen like Pfizer or Moderna, but is more stable and doesn’t require a cold a storage temperature. It’s expected to remain viable for 6 months stored at 2-8 degrees C (35.6-46.4 degrees F).
What else is special about this vaccine? It uses specially prepared moth cells to create the spike protein of the SARS-COV-2 virus. These proteins are then harvested and placed in a nanoparticle suspension and there you have the basis of your vaccine. Injecting the proteins triggers the body’s immune response to the spike protein, and away you go on the path to immunity.
Vaxxinity
Researchers for Vaxxinity have designed peptides (amino acid structures similar to, but smaller than proteins) to mimic key structures within the SARS-COV-2 virus. Basically, instead of using entire proteins, including the infamous “spike protein” of the coronavirus, they are using key piece of proteins to provoke an immune response.
Vaxxinity’s vaccine has cleared Phase 1 testing with good results, with mild side effects reported consistent with other vaccines (soreness, fatigue, etc.). The vaccine is also very stable at refrigerator temperatures.
Vaxxinity is planning on starting Phase 2 testing in Taiwan and Phase 2 and 3 testing in Brazil soon, and work is in progress to tweak the formulation to counter new variants.
Vaxart
Vaxart’s vaccine candidate is especially exciting if it pans out. Why? Because it’s a freakin’ PILL! An honest-to-Jupiter room-temperature stable pill that can be taken orally! This could be a huge game changer if this vaccine pans out. The vaccine-hesitant, especially those who are needle-phobic, might find a pill easier to swallow (yes, I had to say it like that. I’m not sorry.) Also, this could mean that vaccines can be easily shipped and stored, and don’t require a trained person to administer like a shot does. You could get your annual booster at the local pharmacy or even in the mail. It’s hard to overstate how big of a deal this could be if this one makes it all the way through the approval process. And to make this even sweeter, they are also developing an oral liquid form of the vaccine that could be given to young children or people who have difficulty swallowing pills. And their formulation does not use eggs in any stage of the development process, which means a lot of people currently allergic to vaccines developed using eggs should be able to safely take this vaccine if it makes it through to full development.
To make it even more interesting, Vaxart’s vaccine targets not just the spike protein of the virus but also another protein that is important to the coronavirus’ ability to replicate, meaning that the immune system will be given TWO protein targets to develop an immune response to. This will make it harder for variants to evade the vaccine, as variants would have to potentially find a way to evolve both target proteins in a way that would evade an immune response, while still keeping the virus functional. And the second protein does not appear to subject to much mutation in the current crop of known variants.
Vaxart is also developing oral vaccine candidates that only target the spike protein rather than both.
Early research also indicated this vaccine developed a robust immune response in the mucus membranes of the nose, mouth and throat — the “first line of defense” against airborne viruses and also an important factor in reducing viral shedding, the key factor in transmission.
IMO, this is really one to watch. Sadly, at this point Vaxart is barely at the beginning stage of Phase II studies on 3 oral vaccine candidates (1 using both proteins as mentioned, and 2 using only the spike protein). Fingers crossed that this one works out, folks. A room-temperature pill vaccine would potentially be a HUGE factor in getting and keeping this virus under control.
Valneva
Valneva’s vaccine uses killed virus in it’s vaccine candidate. The virus is cultured, inactivated (using a chemical called BPL, used to kill viruses used in other vaccines, so this is not anything new in that regard and has a good track record, for those concerned about “but you’re injecting the virus, won’t that make you GET the illness?” questions), combined with a couple of adjuvants (a substance that enhances the immune response) and injected.
This one is noteworthy Because it uses the entire virus rather than one protein or a small number of proteins from the coronavirus, researchers are hopeful that their candidate will be effective against variants that modify a single protein such as a tweak to the spike protein — a common target of most current vaccines.
This one has made it through Phase II trials and hopes to clear Phase 3 by this fall. A French company, Valneva is mainly targeting the UK market and had been looking to EU approval, but there have been some unexpected hurdles that might prevent an EU-wide deal while still allowing for individual EU members to sign contracts with the company for vaccine delivery.
Sanofi
Sanofi is a French-based company that is taking an off-the-shelf approach, using an existing effective influenza vaccine and replacing the influenza protein with the SARS-COV-2 spike protein.
Sanofi suffered some early setbacks in trials due to miscalculations on dosing. At the moment, they are anticipating seeking approval in the US and EU some time in the 4th quarter of this year. But Sanofi is a well-established pharmaceutical company (some of the others are much smaller, or newer, companies that don’t have as well-established supply chains and manufacturing capacity), so that bodes well to their ability to crank out substantial supplies if they reach approval stage (Sanofi has actually contracted recently to make 200 million doses of Moderna vaccine, and earlier this year had contracted to make 100 million doses of Pfizer vaccine).
CureVac
This is another mRNA vaccine, similar to Pfizer and Moderna, but I’m including it here because it’s anticipated to get approval from the European Medical Agency in the next month or so and has already inked a deal with the EU to deliver up to 405 million doses of its vaccine to EU members, and has a partnership with Bayer where Bayer has agreed to provide manufacturing and logistical support for the vaccine in some countries.
While CureVac is finding itself in competition with 2 other mRNA vaccines, it’s advantage over the other two is it’s stability — it can be stored at regular refrigerator temperatures (41 degrees) for up to 3 months, and can be kept at room temperature for up to 24 hours.
AltImmune
Another potential game changer, AltImmune’s vaccine would be a nasal spray that is stable at room temperature for several months.
This one is still in early stages, though, and is still in Phase 1 trials (which should wrap up this month). The Phase 1 trials are testing the safety and immune response to a single dose and to two doses administered 1 month apart.
In mouse trials, it showed excellent results with a single dose with the company reporting that “a single dose of AdCOVID provided sterilizing immunity in the lungs of vaccinated mice, in contrast to the development of dense pulmonary infection and disease in the lungs of non-vaccinated mice following infection with SARS-CoV-2.”
Like the Vaxart oral vaccine, AltImmune anticipates that its vaccine will create a robust immune response in the mucous membranes of the sinuses, throat, etc., providing “frontline” immune response that will quickly act to counter infection.
AltImmunes expects to report its results from its Phase 1 trial (with participants aged 18 to 55) next month.
In other vaccine news
- The EU, after a contract dispute, has declined to renew its contract with AstraZeneca and instead is turning to Pfizer for its vaccine needs. AstraZeneca’s contract expires in June. In addition to the contract dispute, AstraZeneca is under a bit of a cloud after the clotting issues (determined to be rare events, but which still led many countries to pause administering the vaccine or limiting which populations received it). And now there are new concerns being investigated related to reports of cases of Guillain-Barre syndrome, a rare nerve-degenerative disorder in some who have received the vaccine. The EMA is investigating these reports and there are few details as yet.
- New data from a study in Qatar shows that the Pfizer vaccine is still pretty effective against the South African variant. Recipients of both doses of the Pfizer vaccine were 75% less likely to develop COVID-19 than unvaccinated people, and had complete protection against “severe disease” caused by the variant.
- As Pfizer is on the edge of getting approval for vaccinating 12-15 year olds, a Kaiser Foundation survey finds that 41% of parents of children in that age range say they definitely will not get their children vaccinated, or will only do so if required to do so for school.
- The Kaiser Foundation also note that 15.4% of adolescents in the 12-15 age ranges live in households below the poverty line, which may face special challenges to getting vaccinated (education on where to get vaccinated, access to vaccination locations, etc.).
- Despite only about 34% of the population being fully vaccinated at this point, an increasing number of states are asking for a reduction in their vaccine allocations as stockpiles sit unused and fewer people are coming forward to receive shots. While a slowdown in vaccination rates wasn’t unanticipated, it presents a special challenge now to reach unvaccinated populations and different approaches — for example, finding ways to vaccinate homebound people who want the vaccine, getting vaccines into areas where populations had difficulty getting vaccines, and of course convincing the vaccine-hesitant to get the shots.
- A study among 5,217 of its employees by St. Jude’s Children’s Research Hospital showed that its vaccinated employees were 72% less likely to have asymptomatic COVID than unvaccinated employees. The numbers jumped to a 90% reduction one week or more after receiving the 2nd dose (so many of those asymptomatic cases were among people who had received only 1 dose, or had just received their 2nd).
- The American College Health Association has issued a recommendation that colleges and universities across the country mandate vaccinations for all on-campus students attending classes for the fall semester, subject to supplies and state laws that may apply. Some colleges and universities have already declared whether they will or won’t require vaccinations for the fall semester (here in Iowa, our Board of Regents has already declared they won’t require vaccinations at our 3 state public universities).