vaccine update

Here in the United States, we are continuing to roll out coronavirus vaccines as quickly as possible, although there are a few snags.

The biggest is that the one-shot Johnson & Johnson vaccine is on temporary pause, due to six cases of a rare blood clotting problem that have been reported among women aged 18-48 within two weeks after vaccination. Given that over six million doses have been administered, the percentage affected is tiny, but the two agencies in charge are being cautious, especially as a small number of similar cases have been reported in Europe in connection with the Oxford/AstraZeneca vaccine, which, like the J&J, is an adenovirus-based vaccine. The pause is allowing them to gather and assess data. Additional cases may surface because of the attention this is receiving in the media. It also lets physicians know to ask about vaccine status when a patient presents with blood clot symptoms. This is important because vaccine-related blood clots call for a different treatment regimen. The hope is that the J&J vaccine will again be cleared for distribution within the next two weeks.

The public reaction has been mixed. Some people say that this pause shows how closely public health officials are tracking the various vaccines and their effects, which raises their confidence level. Others are worried that this means the vaccines weren’t sufficiently tested. A few who have received the J&J vaccine are panicking.

As someone who has been involved in vaccine trials, currently the Pfizer/BioNTech coronavirus vaccine but previously trials for flu, adult RSV, and pneumonia vaccines, I can attest that researchers are very careful in how they conduct trials. However, when you have a side effect that seems to appear in such a small number of people, you are unlikely to find it in a trial of thirty thousand people. If it turns out that the blood clot complication does occur, a person is more likely to be struck by lightning than to develop a blood clot after J&J vaccination. I hope this would calm anyone who is panicking, although people often fear rare events while ignoring those that are much more likely to impact them.

I admit that it boggles my mind that, with over thirty-one million known COVID cases in the US and over 565,000 deaths, people would fear an extremely rare side effect more than the virus itself. There are still about 25% of adults who say they will not get vaccinated, which raises the prospect that we won’t be able to stop community spread and end the pandemic because the pool of susceptible people will remain too large. Also, remember that some people who have been vaccinated may still be infected, but their chances of being severely ill are greatly diminished. Still, the way to end the pandemic is to have 85-90% of people vaccinated so that cases of the virus can be contained rather than spreading throughout the community.

It will help when those younger than 16 can be vaccinated. Pfizer has currently asked for permission to add 12-15-year-olds to those eligible after conducting a trial with that age group. Pfizer, Moderna, and others are also conducting research on the best dosages for younger children.

Meanwhile, research is continuing into how long immunity from the vaccine will remain strong. Spouse B and daughter T who received the Pfizer vaccine last August as part of the phase III trial are part of the effort to answer that question. The six month figures showed that immunity remained strong but they will be followed for at least two years to see how that may change with time. The Pfizer CEO Albert Bourla has said that he thinks a yearly booster is a possibility; they have begun studying this with phase I trial participants. We’ll see when B and T have their one-year follow-up in August whether or not they will have extended the booster dose study to phase III participants.

It is my sincere hope that by then we will have been able to fly to the UK to visit our family there and to meet granddaughter JG in person. While we are doing all we can to make that safely possible, it is frustrating to still see so many people not willing to cooperate with public health measures to keep themselves, their loved ones, and their communities safe using masks, distancing, limits on gatherings, vaccines, etc. to end the pandemic.

Yesterday, there was a Congressional hearing at which Dr. Anthony Fauci, one of the leading health officials in the country, was testifying. Rep. Jim Jordan illustrates the dynamic that has resulted in the unfortunate and dangerous politicization of the pandemic. This is a public health issue, not a “freedom” issue. Living in a free society does not mean that everyone is free to do or say whatever they want; we each have a corresponding responsibility not to cause harm to others or damage their rights and human dignity.

This brings me to my last point. The pandemic affects the whole world. Under the prior administration, the United States suffered terrible losses and did not contain the spread of the virus. Under the Biden administration, the US is making progress and has taken some steps to help the rest of the world in the fight against COVID. The US is now part of the COVAX initiative to help distribute vaccines to lower-wealth countries, although this is just getting underway. It has also sent some of its stockpile of the AstraZeneca vaccine, which has not yet been approved for emergency use in the US, to Canada and Mexico where it has been. While I expect the US to retain doses of approved vaccines as boosters, I’m hoping that once everyone who will accept the vaccine in the US has been vaccinated that we will distribute all the other doses to countries that need them, along with whatever other logistical and medical help is needed.

We can never end the pandemic until the virus has nowhere on the globe where it can run rampant. To me, this is a moral imperative. Others may be motivated by economic self-interest. Whatever the reason, it needs to happen.

more good vaccine news

An update to my last post on coronavirus vaccines in the United States:
The Johnson & Johnson vaccine did receive emergency use authorization over the weekend and is currently being distributed. Because the company had manufactured some doses in advance through Operation Warp Speed, there will be some large shipments going out followed by a lag as Johnson & Johnson ramps up their manufacturing operations.

President Biden announced on Tuesday that another large pharmaceutical company with vaccine expertise, Merck, will be helping Johnson & Johnson to manufacture its vaccine. Merck ended a couple of vaccine trials it was conducting due to ineffectiveness and will be aiding the country in manufacturing its rival’s vaccine under the Defense Production Act. This Act is also being used to increase production of other needed items, such as vials.

Unlike the Pfizer/BioNTech and Moderna mRNA vaccines, the J&J vaccine is a more conventional vaccine, using inactive adenovirus to carry the vaccine into the body and activate the immune system. It only requires one dose and can be stored at refrigerator temperatures, so it is much easier to distribute to more rural areas.

While President Biden had previously said that any adult who wanted to be vaccinated would be able to be by the end of July, he now expects that to be possible by the end of May. This would allow most of us to resume what we have been calling “normal life,” although I think that some changes from our old ways of doing things will probably be in evidence indefinitely.

However, there are some big ifs. The first is that individuals would need to almost universally accept the vaccine to prevent it spreading in the community and to minimize the impact of new, possibly more dangerous variants. This would need to happen in every state – and in every country, if unrestricted international travel is allowed to resume. The second is that people would need to continue masking, distancing, limiting gathering size, etc. until most of the adults in the community were immunized or could be rapid-tested to show they were not likely currently infectious. New York is currently piloting holding sporting events using technology to screen for immunization/negative tests to allow higher occupancy for fans.

Another consideration is teens and children. Currently, only the Pfizer vaccine is authorized for use in 16- and 17-year-olds; it is currently being tested in 12-15-year-olds with plans to test in younger children after that. Other companies are also now beginning to study their vaccines in children and teens. Wide adoption of the vaccine among adults is the quickest route to protecting children, given that widespread vaccine use is unlikely for them until 2022.

The wild card continues to be how long-lasting vaccine effects are and how well they prevent serious illness from current and future variants. To that end, spouse B and daughter T are having blood draws this week to evaluate how their immunity is holding up as part of the Pfizer Phase III trial. They received their immunizations in August 2020 and will continue as part of the study into 2022. It’s also possible that Pfizer will be piloting the use of booster shots or of new vaccine formulations to better deal with variants, using the subjects already enrolled in Phase III. They have begun some of this research with Phase I/II participants.

Other vaccine researchers are continuing to study boosters and new vaccines, as well as longevity of immunity. Part of the story about Merck helping to produce the J&J vaccine and other similar partnerships around the world is that the extra doses may be needed as boosters in the future. If not, the surplus vaccines can be distributed through the COVAX initiative internationally to reach underserved populations.

All in all, it’s a hopeful time, but only if people are informed, thoughtful, and community-minded. Please, observe safety measures, get vaccinated when it is your turn, and be kind. We can end the pandemic sooner if we all work together.