Changes are happening…

With many things going around in the world, the coronavirus continue to wreck havoc as things continue to change.

The Food and Drug Administration authorized the emergency use of Pfizer’s COVID-19 booster on Sept. 22 for people over 65, younger adults with underlying conditions and those with jobs that put them at high risk to exposure.

“Today’s action demonstrates that science and the currently available data continue to guide the FDA’s decision-making for COVID-19 vaccines during this pandemic. After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for a booster dose in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others,” said Acting FDA Commissioner Janet Woodcock, M.D. “This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day. As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed.”

This ruling is a scaled back version of President Joe Biden’s administration’s sweeping plan to give third doses to nearly all American adults to ramp up their protection amid the spread of the COVID-19 delta variant.

Under the FDA authorization, vaccinated Americans are eligible for a third dose six months after receiving their second Pfizer shot.

The following day, advisers to the Centers for Disease Control and Prevention met to make their own, more specific recommendations about the booster shot.

The CDC concluded to endorse the booster shots.

CDC Director Dr. Rochelle Walensky signed off on a series of recommendations from the panel, who said boosters should be offered to people 65 and older, nursing home residents and those ages 50 to 64 who have risky underlying health problems. The extra dose would be given once they are at least six months past their last Pfizer shot.

However, there was recommendation that the panel had voted to reject, which was that people can get a booster if they are ages 18 to 64 years and are health-care workers or have another job that puts them at increased risk of being exposed to the virus. Walensky disagreed and put the recommendation back in, and noted that this move aligns with the FDA’s decision.

“As CDC Director, it is my job to recognize where our actions can have the greatest impact,” Walensky said in a statement. “At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.”

The CDC panel stressed that its recommendations will be changed if new evidence shows more people need a booster.

Advisers of the CDC also expressed concern of those who received Moderna or the Johnson & Johnson vaccine. Booster shots for those who received that vaccine have not yet been considered, and it is unclear if it safe to mix-and-match vaccines. To note, despite not having a booster, people are still considered fully vaccinated if they received both doses of the vaccine or the one J&J.

All three of the COVID-19 vaccines used in the U.S. are protective, even with the spread of the delta variant. However, only about 55% of the population in the country is fully vaccinated at this time.

The U.S. has already authorized third doses of the Pfizer and Moderna vaccines for certain people with weakened immune systems, such as cancer patients and transplant recipients. Other Americans, healthy or not, have managed to get boosters, in some cases simply by asking. To clarify, the booster shot is not the same as the third dose of the vaccines.

In more changing moves, California public school students 12 and older could be required to get the COVID-19 vaccine in order to attend classes in person. However, California Health and Human Services Secretary Dr. Mark Ghaly said while the state is considering a vaccine mandate for students, there is ‘no definitive action or decision is being made at the moment.’

“This is not something that is a new part of a conversation,” he said. “There’s been a long conversation about vaccines in schools and their role in protecting students. We, of course, are always looking at the data, understanding where there are opportunities to ensure that California’s vulnerable, those who can be protected, are protected through getting vaccinations.”

The companies of Pfizer and BioNTech showed data that the COVID-19 vaccine is safe and effective for children ages 5 to 11.

“We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the delta variant and the substantial threat it poses to children,” Pfizer chairman and CEO Albert Bourla said in a statement. “Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination.”

There were 2,268 participants ages 5 to 11 in the trial, which, while it still followed a two-dose regimen, used a lesser dose than the amount given to people ages 12 and older, for the “safety, tolerability and immunogenicity” of younger children.

“In participants 5 to 11 years of age, the vaccine was safe, well-tolerated and showed robust neutralizing antibody responses,” the companies said in a news release.

Pfizer and BioNTech plan to share their data with the U.S. Food and Drug Administration, the European Medicines Agency and other regulators soon and will submit a request for emergency use authorization in the United States.

It is currently authorized for emergency use in children ages 12 to 15.

Also taking into effect in the state was the updated guidelines by the California Department of Public Health regarding “mega events.”

The CDPH classifies mega events as indoor events of more than 1,000 people or outdoor events of 10,000 people or more.

Per the updated rules from the CDPH, attendees of indoor events will be required to show proof of vaccination or a negative COVID-19 test within 72 hours. Self-attestation to verify vaccination will no longer be accepted. Previous CDPH guidelines only asked for self-attestation and it applied to events with crowds larger than 5,000 people. It will be recommended that attendees of outdoor events follow those stated guidelines.

The CDPH said these measures for mega events are in effect through Nov. 1. They will review the measure by Oct. 15 and, from there, see if further rules are needed after Nov. 1.

On Sept. 20, the U.S. said it would ease airline restrictions in the fall on travel to the country for people who have vaccination proof and a negative COVID-19 test, which will be in effect in November.

The new policy will replace a patchwork of travel bans first instituted by former President Donald Trump last year and tightened by President Joe Biden that restricted travel by non-citizens who have in the prior 14 days been in the United Kingdom, European Union, China, India, Iran, Republic of Ireland, Brazil or South Africa.

White House COVID-19 coordinator Jeff Zients said they still will require all foreign travelers flying to the U.S. to demonstrate proof of vaccination before boarding, as well as proof of a negative COVID-19 test taken within three days of flight. President Biden will also tighten testing rules for unvaccinated American citizens, who will need to be tested within a day before returning to the U.S., as well as after they arrive home. Fully vaccinated passengers will not be required to quarantine. There will be no immediate change at this time to U.S. land border policies, which restrict much cross-border travel with Mexico and Canada.

The CDC will require airlines to collect contact information from international travelers to facilitate tracing.

It was not immediately clear which vaccines would be acceptable under the U.S. system and whether those unapproved in the U.S. could be used. Zients said that decision would be up to the CDC.

Worldwide, air travel is still down more than half from pre-pandemic levels, and the decline is much sharper for cross-border flying. By July, domestic travel had recovered to 84% of 2019 numbers, but international travel was just 26% of the same month two years ago, according to figures this month from the airline industry’s main global trade group, the International Air Transport Association.

As we continue to move forward, let us all remember to stay positive through it all. Before everyone knows it, normalcy will be upon us.