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By Helen Branswell Feb. In a feat that even a couple of years ago would have seemed completely out of reach, vaccines to protect against the new disease were being used before the first anniversary of the disclosure that a new threat existed. This is truly extraordinary. In the United States, three vaccines are available. In August 2021, the FDA gave full approval to the vaccine developed by the partnership of Pfizer and German manufacturer BioNTech for people 16 and older.

The Pfizer shot first received emergency authorization in mid-December, followed closely by the one developed by Moderna with assistance from the National Institute of Allergy and Infectious Diseases. In late February came a third. The vaccine was seen as a potential game-changer. It is cheaper, both on a per-dose basis and because only one dose is needed. A production snafu in the hands of a contract production company contaminated 15 million doses, which had to be destroyed. And in mid-April, the FDA and CDC recommended states pause use of the vaccine as they investigate whether the vaccine triggers a rare but serious side effect - the development of diffuse blood clots, even though the few individuals who developed the condition had low platelet levels.

This article will be updated as developments occur. The Pfizer and Moderna vaccines are made using messenger RNA, or mRNA, a technology that delivers a bit of genetic code to cells - in effect, a recipe to make the surface protein (known as spike) on the SARS-2 virus. The proteins made with the mRNA instructions activate the immune system, teaching it to see the spike protein as foreign and develop antibodies and other immunity weapons with which to fight it.

A harmless adenovirus - from a large family of viruses, some of which cause common colds - has been engineered to carry the genetic code for the SARS-2 spike protein. Once the adenovirus enters cells, they use that code to make spike proteins. The Pfizer vaccine has been approved for use for people aged 16 and older, though its EUA also extends to people ages 12 to 15. In August 2021, the FDA also authorized third doses of the mRNA vaccines for people who have certain immunocompromising conditions, amid growing evidence that they do not get adequate protection from the normal two-dose regimen of the Pfizer-BioNTech or Moderna vaccines.

The Pfizer and Moderna vaccines have shown astonishing - and essentially equivalent - degrees of efficacy, at least in the early stages after vaccination. The vaccine appeared to be more or less equally protective across age groups and racial and ethnic groups. The Moderna vaccine was 94.

The vaccine appeared to be equally effective across different ethnic and racial groups. Pfizer started counting cases from seven days after receipt of the second dose of vaccine, while Moderna waited until day 14 to start counting cases.

And there were no hospitalizations or deaths in the vaccine arm of the trial after the 28-day period in which immunity developed. The vaccines all appear to have lost some efficacy against infection with the Delta variant, which became dominant in the United States in summer 2021.

It also appears that, while the vaccines are preventing many infections, vaccinated people who have breakthrough infections with the Delta variant can transmit the virus to others (though they are not as infectious as unvaccinated people).

Still, even with Delta, studies indicate that the vaccines have maintained their protectiveness against severe disease and death. Both the Moderna and the Pfizer vaccines require two shots: a priming dose, followed by a booster shot. Moderna went with a much larger dose of vaccine, 100 micrograms. It means the company is using a little more than three times as much vaccine per person as Pfizer is.

The company is also testing a two-dose regimen, with the two shots given eight weeks apart. In the vernacular of vaccinology, shots that trigger a range of transient side effects in a lot of recipients are known as reactogenic. All of these vaccines - in fact, most if not all the Covid-19 vaccines that have reported data so far - fall into the reactogenic category. The Advisory Committee on Immunization Practices, an expert panel that helps the Centers for Disease Control and Prevention set vaccination policies, advised hospitals early in the rollout that they might want to stagger vaccinations among employees in case some feel too unwell to work the day after being vaccinated.

The most common side effects are injection site pain, fatigue, headache, muscle pain, and joint pain. Some people in the clinical trials have reported fever. With the Pfizer and Moderna vaccines, side effects are more common after the second dose.

Younger adults, who have more robust immune systems, reported more side effects than older adults. To be clear: These side effects are a sign of an immune system kicking into gear. They do not signal that the vaccine is unsafe. To date there are no serious, long-term side effects associated with receipt of these vaccines, which will be closely monitored as their use expands.

There have been reports of severe allergic reactions to the mRNA vaccines. Both the Pfizer and Moderna vaccines appear, on rare occasions, to trigger anaphylaxis, a severe and potentially life-threatening reaction. People who develop anaphylaxis must be treated with epinephrine - the drug in EpiPens - and may need to be hospitalized to ensure their airways remain open. The CDC says people should be monitored for 15 minutes after getting a Covid-19 shot, and 30 minutes if they have a history of severe allergies.

It will take time to come up with a firm estimate of how frequently this side effect occurs. The most recent data from the CDC suggest that anaphylaxis occurs at a rate of about 2. Many of the people who have developed anaphylaxis have a history of severe allergies and some have had previous episodes of anaphylaxis.

The mRNA vaccines carry a small risk of myocarditis and pericarditis, two types of heart inflammation that are most commonly seen soon after people receive their second shots, health officials have said.

Men under 40 seem to be at highest risk, particularly those aged 12 to 17. Most cases reported have been mild and resolved. The thrombotic events include diffuse clots and low platelet levels, an unusual combination that can be dangerous if treated improperly.

The normal treatment for clots - a blood thinner called heparin - would make the problem worse, the FDA said, warning doctors to ask for a Covid-19 vaccination history if they see patients with that configuration of symptoms. The company said it saw no such signals. The CDC recommends until those studies are conducted, the choice of whether to get vaccinated should rest with the person who is pregnant or lactating. This is a more permissive stance than has been taken in some countries, which have said people who are pregnant should not be vaccinated with these vaccines.

It can be stored for at least three months at the temperature of a regular refrigerator.