Covid-19 vaccine basics: Why the rollout is so slow, who can get doses, and what about side effects

It seems like it’s all anyone wants to talk about these days: Covid vaccine.

When can we get it? How can we find out? How well will the vaccines work? How close will they get us back to the life we see in TV shows and movies filmed in the before times, when only health workers and trick-or-treaters wore masks and social distancing wasn’t part of anyone’s vernacular.

We all have questions; Heck, we’re waiting for our chance to be vaccinated, too. While we wait, we figured we’d try to find some answers to the questions we’re hearing and asking ourselves. Here goes.

Why is the vaccination process moving so slowly?

There are a bunch of reasons. It takes time to get vaccination programs up and running. It’s expensive to do this work, but U.S. states have only started receiving significant federal funding for their vaccination delivery efforts in the past couple of weeks; it was tied up in the months long delay in getting Covid-19 relief funding through Congress.

Another reason: Distribution is just plain complicated. The two vaccines currently in use have stringent cold-chain requirements. They need to be shipped and stored frozen. One of them, the vaccine made by Pfizer and BioNTech, has to be kept at an ultra-cold temperature, -94 Fahrenheit. After thawing, it has to be used within five days. These vaccines are difficult to use and easy to waste through spoilage. 

Finally, the reality is there isn’t that much vaccine available yet. The vaccination programs are becoming more efficient, but the flow of vaccine doses from manufacturers isn’t growing exponentially at this point.

When will we get more vaccine? 

Good question. Unfortunately, it’s not clear when large amounts of vaccine will be available in the United States. Operation Warp Speed, the government program to fast-track development and distribution of vaccines, had promised to deliver 300 million doses by Jan. 1. That didn’t happen — not by a long shot.

A spokesperson for the Department of Health and Human Services said recently the agency’s best prediction was that the government will have received 40 million doses in total by the end of January, and 200 million doses by the end of March. That’s only enough to vaccinate 20 million and 100 million people, respectively.

Why aren’t there more vaccine doses at this point? 

Part of the issue is that vaccine manufacturers overpromised what they could produce. Part of the issue is only two vaccines have been authorized for U.S. use so far, the mRNA vaccines made by the Pfizer-BioNTech partnership, and by Moderna. If more vaccines are authorized by the Food and Drug Administration, that will increase the amount of vaccine available for use, though the increase won’t be immediate.

When will the other vaccines the government invested in become available?

We expect to see clinical trial data this week or next on a one-dose vaccine made by Janssen Pharmaceuticals, Johnson & Johnson’s vaccine division. If the vaccine is protective enough, the company can apply for an emergency use authorization from the FDA. If all goes well, that EUA could be issued in mid-February, Moncef Slaoui, the outgoing co-chair of Operation Warp Speed, said recently.  J&J has also hedged its bets; in addition to the one-dose shot, it is testing a two-dose vaccine, but data from that part of its clinical trial will take longer to come in.

The J&J vaccine could be a game changer. From an administration point of view, one dose is easier than two and a delivery of, say, 100 million doses will protect twice as many people as the same number of doses from a manufacturer making a two-dose vaccine. Plus the vaccine is “fridge stable” — it doesn’t need to be shipped frozen like the Pfizer and Moderna vaccines do.

But the gains the vaccination program would see from the J&J vaccine won’t come immediately. The company won’t have much in the way of doses to supply to the U.S. until April, Slaoui said.

Next up should be the AstraZeneca vaccine, which has already been authorized for emergency use in Britain and India. An EUA application to the FDA will likely be submitted in early March, Slaoui said. After that, Novavax may be in a position to apply for emergency use clearance in late March or early April. That’s it for the first crop of U.S. vaccines; others from Sanofi Pasteur and Merck are further back in the pipeline.

Who is eligible to get vaccinated at this point? 

That depends on which state you live in.

When the vaccination program began in December, health workers and the residents and staff of nursing homes were the only people theoretically eligible to get vaccinated, though some people who happened to be around when vaccinators were in a “use-them-or-junk-them” situation have been vaccinated out of turn. (That’s as it should be, Nancy Messonnier, a senior official of the Centers for Disease Control and Prevention said recently. “Don’t leave vaccine in the vial.”)

In the final days of the Trump administration, Alex Azar, then Health and Human Services secretary, urged states to start vaccinating more broadly — to make vaccine available to people 65 and older as well as people with a medical condition that has been seen to increase a person’s risk of developing severe Covid if infected. 

Recently President Biden has suggested states should now be trying to vaccinate people 65 and older plus frontline essential workers such as teachers, and people who work in food distribution. 

Whichever approach the states are using, there isn’t currently enough vaccine for all those people.

States have leeway in how they’re applying these recommendations. And who they are vaccinating depends on how far they’ve gotten to date and how much vaccine they have on hand. 

How are we supposed to find out when and where we can get vaccinated?

A good place to start is this page on the CDC’s website. The light green box in the center of the page — “How do I get a vaccine?” — has a pull-down menu where you can select your state and get forwarded to its Covid vaccine website. If you select Connecticut, for instance, it will show you that the Constitution State is currently vaccinating people 75 and older, and how to try to book an appointment if you are eligible. It will also warn you high traffic volume may mean you’ll need to make a number of tries. 

If you select Arkansas, you will see that Bill Clinton’s home state is currently vaccinating people 70 and older and teachers. You’ll also learn where those people can find vaccine. 

Some states seem to have established fairly orderly systems — though you probably need to be computer-savvy to take advantage of them — while others, not so much.

We asked people on Twitter recently to disclose how they managed to get an appointment to be vaccinated. (You can read the dozens of replies here.)  Some people got a call from their doctor; others heard of opportunities from friends or colleagues; some signed up online for appointments that in some cases seemed pretty easy to book, but in others seemed to be exercises in frustration. 

Where will vaccines be administered?

The situation here is fluid. At some point family doctors will have vaccine doses they can administer to their patients. Pharmacies will, too. (Some already do.) And CVS and Walgreens, two major pharmacy chains, have contracts to vaccinate in nursing homes in most parts of the country.

But relying on those standard approaches isn’t going to be enough, public health authorities realize.

Increasingly, as vaccine supplies expand, public health will likely turn to mass clinics. Massachusetts is using Gillette Stadium, home of the New England Patriots; in Los Angeles, Dodger Stadium, which had been a drive-in Covid testing site, has been transformed into a vaccination location.

Messonnier, who is director of the CDC’s National Center for Immunization and Respiratory Diseases, said during a recent live chat with STAT that a mix of traditional and innovative approaches is going to be needed. Schools, churches, mobile clinics could be part of the mix. Companies that normally offer on-site flu shots to their staff could consider Covid vaccine clinics for employees and their families, she suggested.

Have we learned more about side effects of the vaccines or serious problems associated with their use? 

It seems like Covid-19 vaccines are all a bit reactogenic, meaning people should assume they may have arm pain or feel flu-ish after getting a shot. In the clinical trials conducted on these vaccines, some people reported malaise, fatigue, chills, and even fever for a day or two after getting vaccinated. While temporarily unpleasant, these are signs the vaccines are actually activating an immune response. These side effects are typically more common after the second dose of a two-dose vaccine.

There have been reports of anaphylaxis, a severe and potentially life-threatening allergic reaction, after administration of both the Moderna and the Pfizer-BioNTech vaccines. Anaphylaxis must be quickly treated with epinephrine, the drug in EpiPens. As of last week, the rates at which these allergic reactions were occurring was about 2.1 cases per million doses of the Moderna vaccine and 6.2 cases per million doses of the Pfizer, the CDC reported. The agency says people administering the mRNA vaccines must have epinephrine supplies on hand and should monitor people for 15 minutes after they get vaccinated, and 30 minutes if a person has a history of severe allergies.

A few people in the Pfizer and Moderna clinical trials developed Bell’s palsy, a partial and generally temporary paralysis of some facial muscles, though it’s too soon to know if they were linked to vaccine use. One of the people who developed Bell’s palsy was in the placebo arm of the trial.

Will Covid vaccines prevent people from getting infected and transmitting SARS-2? Or do they only prevent people from developing symptomatic disease? 

The clinical trials developed to test Covid vaccines were designed with speed in mind; the goal was to find out as quickly as possible if the vaccines would prevent symptomatic and severe disease and save lives. Finding out if vaccinated people were developing symptom-free infections and were therefore emitting infectious virus would have been a big additional piece of work. 

As a consequence, the answer to the transmission question will only come over time, as researchers study how effective the vaccines are in the real world. But a number of experts are quietly confident that the vaccination will cut back substantially on SARS-2 transmission.  

“I’ve been called an optimist before, but I feel that vaccines that can prevent 95% of symptomatic infections have got to be preventing infection in the nose and therefore transmission should be reduced,” said Akiko Iwasaki, a virologist and immunologist at Yale University.

“The reason I say this is because vaccines are not designed to prevent symptoms, they’re designed to prevent infection. And so I just don’t see the possibility of such a disconnect between asymptomatic infection and symptomatic infection in vaccinated people.”

What do the new variants — the mutated viruses spreading in and from Britain, South Africa, and Brazil — mean for the vaccines now? 

Mutations in the virus’s genome can change its appearance. The fear is that the antibodies generated in people who have been vaccinated won’t be able to identify the virus if it’s changed.

That said, the vaccines still have some tricks up their sleeves. For one, they induce the immune system to mount a “polyclonal” response, replete with different antibodies that can home in on different parts of the virus. Changes in the viral genome for one of those parts, then, shouldn’t keep the rest of the antibodies from recognizing and fighting off the virus. 

Experts also stress it’s not a black-and-white question of whether vaccines work or not. It’s a matter of degrees. It’s possible that a particular mutation, or, more likely, a particular combination of mutations, will have some impact on the effectiveness of vaccines. But both the Pfizer and Moderna vaccines produced such stellar levels of protectiveness in clinical trials that experts are heartened that even if the shots lose some of their potency, they will still broadly be able to protect people from Covid-19. 

Eventually, though, as the number of mutations accrue, experts say vaccines should be reformulated to better suit dominant strains, especially as it’s expected that people will have to get booster shots perhaps every few years. Updating the vaccines is a process that should just take weeks to months in terms of design, though scientists are stressing that the infectious diseases and regulatory communities need to prepare for this now, to figure out what kind of data will be required to greenlight such vaccines, how to shift manufacturing operations, and when to make the call that vaccines need to be tweaked.

How much will Covid-19 shots cost?

Nothing out of pocket. Your tax dollars have already paid for these vaccines. You should not be charged for the vaccine or for its administration.  

I’ve been vaccinated. Can I party?

Covid vaccines are a portal to a more normal way of life. But we’re not all going to be walking through that portal at the same time. We still don’t know whether people who have been vaccinated can be infected with and shed the SARS-2 virus. We’ll need to see how well the vaccines work to protect against the new variant viruses.

That means as long as there is a lot of SARS-2 virus making the rounds, people will need to continue to take precautions. At some point, hopefully, we’ll be able to doff our masks and hug people who aren’t part of our households. But for the near term, at least, we’re going to need to be prudent. 

We’ve gained some ground. But the virus still has the upper hand.

Read original article here.