UPDATE: FDA Grants Approval to Pfizer Vaccine, Boosters Required

Vaccinated Americans have another round to go, according to the CDC. News broke this week that those who are fully

Vaccinated Americans

Vaccinated Americans have another round to go, according to the CDC. News broke this week that those who are fully vaccinated with Pfizer and Moderna shots will need to go back for a third, a booster that will renew and extend protection. And those boosters will be available soon. This is both good and bad news, as a new study reveals that the one demographic still ineligible for the shots – children under 12 – may be more effective at spreading the virus than their older siblings. 


Boosters Starting in September

Vaccinated Americans

US health officials and medical experts have come together to issue a joint statement with one message: time for boosters. CNN reports, “‘We are prepared to offer booster shots for all Americans beginning the week of September 20 and starting 8 months after an individual’s second dose,’ US health officials, including CDC Director Dr. Rochelle Walensky and FDA Acting Commissioner Dr. Janet Woodcock, said in the statement.

‘At that time, the individuals who were fully vaccinated earliest in the vaccination rollout, including many health care providers, nursing home residents, and other seniors, will likely be eligible for a booster. We would also begin efforts to deliver booster shots directly to residents of long-term care facilities at that time, given the distribution of vaccines to this population early in the vaccine rollout and the continued increased risk that COVID-19 poses to them,’ the statement said.”

The officials say in the statement that it’s clear that the vaccinations are working. According to the National Review, “Less than 0.001 percent of this population have suffered severe or fatal cases of COVID when they contracted it post-vaccination.” This isn’t to say that vaccinated individuals aren’t catching COVID, they are. Especially the highly transmissible Delta variant. But they are quite unlikely to need hospitalization or die when infected. Nearly all of those suffering from severe complications due to COVID-19 are unvaccinated, which is why this is often now referred to as, “a pandemic of the unvaccinated.”

But it’s also clear that the protection wanes over time, just like antibodies gained from natural infection with COVID-19 do. 

When Will Children Under 12 Be Eligible for Vaccines?

Health officials believe that the boosters may help turn the corner in the battle against the pandemic, which is good news. Re-upping vaccinated individuals’ protection against the virus is a good thing, and having boosters available to do that is again – a good thing. But what about those who can’t get vaccinated yet? Children under 12 still aren’t cleared to receive the vaccine, and with school back in session now or soon, this delay in vaccination is worrying parents and teachers across the country. 

Especially in the face of a new study that shows young children are more likely to pass on the virus than their older siblings. Fox News reports, “The study, published in JAMA Pediatrics, examined 6,280 households between June 1 and December 31, 2020, that reported a pediatric COVID-19 case. Older children were more likely to be involved in the initial case, and 27% of the 6,280 households reported a secondary infection involving another member.

Data revealed that children ages 0 to 3 years old, although less likely to bring the infection into the house, were more likely to spread the virus to another member than those ages 14 to 17 years old. Children ages 4 to 8 also had increased odds to spread the virus, as did those ages 9 to 13, but the greatest was among the younger population.” 

Young children do still appear to transmit the virus at a lower rate than adults, though, which is the only silver lining. But there are ways to protect this vulnerable demographic. Time shares this urgent plea, “In the meanwhile, there are other actions we can take to protect our kids. Children under 12 are not yet eligible for vaccines—but their parents, grandparents, aunts, uncles, older siblings, teachers, and coaches are. The risk of severe COVID-19 for these older groups is higher, and if they become infected, they can transmit the virus to children under 12. There is no reason for those eligible to delay vaccination, particularly with rising numbers of positive COVID-19 tests throughout the country. Vaccines save lives. We implore parents and caretakers to get vaccinated themselves to protect vulnerable children from infection.”

And beyond that, masking is effective at reducing transmission. Combined with responsible social distancing and vaccinating of caregivers and family members, children can be protected. But it’s in the hands of people who may be reticent to get the shot or mask – a devastating reality for families who need their children to return to schools. 

Delta Variant Challenges Even the Vaccinated

Vaccinated Americans

Unfortunately, until more people are vaccinated and more universal masking is practiced, the Delta variant will continue to rip through unvaccinated populations and spread to the vaccinated as breakthrough cases. Parts of the population are acting as though the pandemic is over, which is pushing businesses to reopen, schools to slack on preventative measures, and people to gather again in large groups.

So the only way to put the COVID-19 pandemic behind us is with a highly vaccinated population who receives occasional boosters to re-up their protection, and temporary widespread masking. In a deeply divided nation, both are hard sells to some. However, with Fall coming and numbers rising, everyone will soon have to face the reality that the Delta variant is here to stay for now. Some experts believe that the pandemic will eventually turn into an endemic phase. That means that COVID-19 would be around seasonally and occasionally surge like the cold or flu. But in a vaccinated population, it can become far less deadly and transmissible. The challenge is to get to that point. But first, those who are vaccinated will need to line up starting in September, 8 months after their original shots, and get another dose of protection. It’s not that the shots don’t work, it’s that the antibodies don’t stick around forever. In a dynamic system like the human body, that’s not surprising. 

UPDATE 8/23/21

Pfizer COVID Vaccine Granted FDA Approval; What Now? 

It’s been eight months since the FDA granted Emergency Use Authorization (EUA) to Pfizer and BioNTech’s COVID-19 vaccine. Now, that vaccine has received full FDA approval. It’s a huge step in the fight to increase vaccination rates. But how does the approval process change things, and what’s next? 

CBS reports, “The approval caps a months-long ‘sprint’ by the FDA to clear the shot’s final remaining regulatory hurdles in record time, scrutinizing reams of the company’s latest safety data and conducting inspections at Pfizer’s vaccine factories around the world.

‘While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.,’ said the FDA’s Acting Commissioner Janet Woodcock said in a statement.”

A significant percentage of Americans have been hesitant to get the COVID vaccine due to its previous EUA-only status. Full FDA approval may turn the tide in the battle to increase vaccine rates. With the approval, those who have hesitated may finally move forward. This hesitation is often due to the fact that people misunderstand what EUA-only means, thinking it means that the vaccine is not yet safe. But the difference between EUA and full approval is just months of analyzing data, data that’s already been scrutinized in order to get the EUA approval in the first place.

However, whatever people’s reasons to hesitate to get the EUA-only vaccine, they will hopefully be put to rest now. The urgency to raise vaccination rates across the country, especially across the Southern Bible Belt, is a race against time. With school back in session or starting soon in most districts across the country, and the Delta variant ripping through unvaccinated populations, the FDA approval may be the only hope of children under 12, who are still too young to be vaccinated. Until the vaccine is given approval for that age group, only a highly vaccinated 12+ population will keep them safe.

The FDA’s full approval may also clear a path for vaccine mandates at businesses and government agencies. This is a concern among the vaccine-hesitant, but with the vaccine the only real hope to turn the pandemic from active into an endemic phase – where the virus is still present but is more background and less deadly, like the common cold – mandates may be the only path forward.