2021 COVID Report: “Navigating Back to Normal”

The State of the Virus & Effectiveness of Vaccine Efforts Worldwide

The arrival of safe and effective COVID-19 vaccines is a major development in the coronavirus pandemic. As more people are vaccinated, families and communities will be able to gradually return to a more normal routine.

There were two reports that delivered resounding evidence that vaccines provide virus protection, including the currently circulating variants. In the US, the CDC reported on a study of 66 million people who had completed the vaccination protocol, and of those 66 million, only 5,800 were re-infected, and most cases of those reinfections were mild.

In Israel, looking at 460,000 COVID infections, 85% of the infections occurred in unvaccinated persons and 14% occurred in those partially vaccinated. Most infections occurred within one to two weeks of receiving the first dose. The infection rate for fully vaccinated persons was under 1%, concluding that the vaccines are working.

In January, Israel suffered the highest infection rate per capita in the world. They had vaccinated half their residents by March 16th, and now infection rates have plummeted 98% since peaking in January. Israel now has one of the lowest documented infection rates in the world.

The U.K.’s infection rate exceeded most countries in January, including Israel. The U.K. has one of the more aggressive vaccination efforts, which has played a vital role when trying to minimize the spread of the virus. The country has administered five times as many doses per person as the worldwide average and two-and-one-half times that of the European Union. Since that time, their COVID infection rate has plunged 96%.

COVID infections have started spiking outside the U.S. recently where the variants have hit India hardest with a peak of daily cases at 414, 188 on May 6th. Brazil is seeing as many new cases each day as the U.S. and one-quarter of all recent COVID deaths globally. Croatia, France, Sweden, and Turkey report the highest per capita new case rates of large countries. All of these countries have low vaccination uptake. France leads this group but has administered only 54 doses per 100 people. India trails far behind, at 15.

The Fourth Wave of COVID-19 in the US

The United States is in the middle of the fourth wave of infections, which would likely be substantially worse if not for a robust vaccination effort. The initial three waves commenced in March, June, and October 2020. Within a month, cases exploded 200 to 300% each time when new variants fueled new infections.

New cases have grown only 30%, which is six to ten times slower than during earlier waves as a result of the vaccine effort. In less than four months, one-fourth of the entire population has already completed the vaccination protocol. Among senior citizens, four in five have participated thus far and two-thirds have been fully vaccinated.

A robust vaccination program lowers the risk of COVID-19 deaths. Deaths in the U.S. have decreased dramatically since February from thousands per day to 150 on May 31st. More recently, younger adult patients outnumbered senior citizens more than two-to-one, showing vaccinating senior citizens has worked.

According to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research  (board-certified in internal medicine, hematology, and medical oncology), the variants in the laboratory seem to be susceptible to the immune response by the currently deployed vaccines. With one dose, the antibody titers are actually not very high, it’s the second dose that gets the very high titers that are capable of neutralizing new variants.

Public health officials will play a vital role in influencing the public. Will participation continue to grow or will the U.S. soon find its point of resistance among young adults? Answers to these questions may determine if and when we return to normal.

FAQs Regarding the Vaccines in the US

Are they safe?

The Pfizer and Moderna vaccines authorized by the FDA have very good safety records. The FDA granted emergency use authorization (EUA) because research data from large clinical trials have shown them to be safe and effective.  

The FDA is tasked with ensuring that the COVID-19 vaccines that ultimately reach the public are both safe and effective and that they have undergone a rigorous evidence-based and transparent process. The FDA and CDC have a robust safety monitoring process for the vaccines as they are administered to millions of people after being authorized.  The U.S. vaccine safety system continues to watch for any signs of problems.

What steps were taken to make sure the COVID-19 vaccines are safe?

Safety is always a top priority as federal agencies work with vaccine manufacturers to develop and authorize new vaccines. All vaccines go through clinical trials to test safety and effectiveness. For the COVID-19 vaccine, the FDA set high safety standards through multiple phases of testing for vaccine developers to meet. In the case of the coronavirus pandemic, a vaccine or medicine is needed to address an emergency situation.

Once it is shown to be safe and effective, the FDA can grant it an emergency use authorization, or EUA. A EUA allows a vaccine, treatment, or medication to be used before the formal FDA approval. Once a vaccine gets a EUA and is being given to people, the FDA and the U.S. Centers for Disease Control and Prevention (CDC) continue to watch carefully to make sure no problems arise. Data on the vaccine’s safety record accumulates over time when more and more people who receive it report their experience and any side effects that may have occurred. These adverse events after vaccination are reported through the Vaccine Adverse Events Reporting System (VAERS).

The COVID-19 vaccines were developed in under a year, not by cutting any corners, but by removing dead space, and that was to manufacture at risk while clinical studies were undergoing. Post-marketing surveillance has been used, which is done for all vaccines, but it takes on particular relevance when there wasn’t as long of a safety follow up-for the vaccines.

One of the key parts of this has been they wanted to see vaccines that would have at least 50% efficacy over placebo, with a lower bound of the 95% confidence interval that was greater than 30%. The FDA also asked for a minimum median of two months follow-up after the final vaccination of a series, and that’s because most adverse events with vaccines appear within the first 42 days after vaccination.

Have there been any COVID-19 vaccine safety concerns?

Other than the Johnson & Johnson/Janssen (J&J) vaccine pending CDC and FDA reviews, none of the original vaccine trials have reported any serious safety concerns. Trials for the vaccines have had fully independent safety monitoring boards, and safety data are continuously reviewed by the FDA and expert panels. The number of serious problems in test participants was very low, and there was little difference in negative effects between those who received the actual vaccine and those who received a placebo.

The CDC and the FDA recommended that healthcare providers temporarily stop using the J&J COVID-19 vaccine while they investigate reports of six people in the U.S. developing a rare and severe type of blood clot after receiving the J&J vaccine. These adverse events appeared to be exceedingly rare, with only six reported cases out of more than 6.8 million people who were vaccinated with the J&J COVID-19 vaccine.

Is there a risk of allergic reaction from the COVID-19 vaccine(s)?

According to the CDC, anyone who has a severe allergy (e.g., anaphylaxis) to any of the vaccine ingredients should not receive that vaccine. They suggest that people with allergies to certain foods, insects, latex, and other common allergens can safely receive the COVID-19 vaccine. Those with a history of severe allergic reaction (anaphylaxis) to injectables or other vaccines should discuss the vaccination with their doctor, who can evaluate and assess their risk.

What are the side effects of the COVID-19 vaccine?

Adverse reactions with the COVID vaccines typically occur within 12 to 24 hours of vaccination and resolve within days. Severe anaphylaxis was experienced between days 6 and 13, which has shown to have decreased dramatically down to about one in 250,000.

Some people notice pain or swelling where they got the vaccine. People have also experienced fever, muscle aches, chills, fatigue, headaches, or a combination of these symptoms. Side effects may last about a day or two and do not signify illness. These are signs that your immune system is responding and preparing to fight the coronavirus if you catch it. If symptoms persist, you should call your doctor.

Are side effects different from the first to the second shot?

Both the Pfizer and the Moderna COVID-19 vaccinations involve two injections separated by several weeks.  If you had COVID-19, the first injection may cause more noticeable side effects than for people who have not had the virus. If you have never had COVID-19, you may notice more side effects after the second dose than after the first dose.

How was the COVID-19 vaccine developed so quickly?

In the past, vaccines have taken many years to develop. However, the relatively quick development of this vaccine does not mean safety measures were skipped. There are several reasons why the COVID-19 vaccines were developed faster than other vaccines.

The technologies used to develop the COVID-19 vaccines have been years in development to prepare for outbreaks of infectious viruses and the manufacturing processes were ready very early in the pandemic. Multiple countries shared genetic information about the SARS-CoV-2 coronavirus when it was available, which gave an early start at finding a vaccine. So, collaboration worldwide was a huge advantage.

The vaccine developers conducted some stages of the process simultaneously to gather as much data as quickly as possible.  Lots of people wanted to enroll as study volunteers, so there were enough research participants to test the COVID-19 vaccine, which is important because a lack of volunteers can often slow down clinical trials.

Also, since the SARS-CoV-2 coronavirus is so contagious and widespread, many volunteers who got the vaccine were exposed to the virus, making the trials take a shorter time to see if the vaccine worked. Additionally, companies began manufacturing vaccines ahead of their authorization or approval so some supplies would be ready if authorization occurred. In other words, the process was streamlined and manufacturers were already one step ahead so they could act when they received the proper authorization.

Why is it important that I consider getting the COVID-19 vaccine?

Though the chances are small, you could still get COVID-19 and not have symptoms, so you might be able to infect another person without knowing it. Studies are looking at whether the vaccine, even when effective at preventing disease, keeps a person from harboring the virus and passing it to others. According to Dr. Marks, director of the FDA’s Center for Biologics Evaluation and Research, there appears to be a 70% to 80% reduction in the ability to transmit asymptomatically after you have been fully vaccinated.

All authorized COVID-19 vaccines are highly effective in preventing serious disease, hospitalization, and death from COVID-19. The Centers for Disease Control and Prevention (CDC), encourage those interested in getting vaccinated to take whichever vaccine is made available from any legitimate and authorized organization.

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