The Food and Medicines Administration (FDA) approved on Wednesday the updated vaccines against COVID-19, but limited its use for many people and withdrew permission for one of the two available for young children.
Pfizer, Modern and Novavax vaccines were approved for all the elderly. However, its use in young adults and children to only those with at least one high -risk health condition, such as asthma or obesity, were restricted. This is a barrier in access for millions of Americans to vaccines that bent a disease that caused millions of dead: now many will have to demonstrate that they are at risk, and millions that may want to vaccinate will suddenly discover that they do not meet the requirements.
In addition, the Pfizer vaccine will no longer be available for children under 5 years, after the FDA announced that it revoked the emergency authorization of the vaccine for that age group.
Parents may continue requesting the vaccines of the modern rival pharmaceutical company, the other HRNM vaccine manufacturer, which has the total approval of the FDA for children from 6 months. However, the spikevax vaccine of this company is only approved for children with at least one serious health problem.
Renewed vaccines are directed to a newer version of the virus in continuous evolution and are planned to begin to be distributed immediately. But they could spend days or weeks before many Americans know if they can receive it, since access depends on various decisions of federal health advisors, private medical insurers, pharmacies and state authorities.
The new restrictions, advanced by FDA officials in May, suppose a change with respect to the previous policy of the United States, which recommended an annual vaccine against COVID-19 for all Americans from 6 months of age.
This approach reflects the growing skepticism about the current risks of COVID-19 and the need for annual reinforcement dose by the Secretary of Health, Robert F. Kennedy Jr., and the FDA Commissioner Marty Makary, both open critics of large-scale vaccination.
“The American people demanded science, security and common sense. This framework offers the three things,” Kennedy wrote on social networks.
Kennedy said that the Novavax vaccine is only available for people 12 years or more, not for younger children, and that is subject to the same risk -based restrictions that are currently applied to modern and Pfizer options. It is the only covid-19 vaccine based on country protein.
Some medical groups, including the American Pediatrics Academy, have opposed the new restrictions, claiming that they can prevent access to the vaccine to families that wish to protect their children. Last week, the group offered its own recommendations for children, stating that annual vaccines against COVID-19 are highly recommended for children between 6 months and 2 years old, and advisable to older children.
This differs from Kennedy’s latest guidelines, which do not recommend vaccines for healthy children of any age, but claim that children can be vaccinated after consulting with a doctor.
Many countries have reduced vaccinations against COVID-19 in recent years, and some American experts indicated that change makes sense here, since almost all Americans have some protection thanks to vaccines or previous infections.
However, implementing the change presents a series of logistics problems.
Insurers usually base their decisions on vaccine coverage on the recommendations of a panel of advisors to the centers for disease control and prevention (CDC), but some pointed out that they will also take into account the opinion of groups of medical professionals, such as the American Medical Association.
Earlier this year, Kennedy dissolved the CDC panel and replaced its members for several doctors and researchers who have repeatedly questioned the safety of vaccines and ingredients of common use. The panel is expected to meet in September, but a specific date has not yet been set or the agenda has been published.
Depending on the advice of the panel it is possible that Americans under 65 have to present documentation on a severe medical condition before being able to vaccinate. What complicates implementation is the fact that pharmacists, who manage most vaccines against COVID-19 in the United States, are not usually obliged to collect such information. In addition, laws that regulate their ability to administer routine vaccines vary according to the State, where pharmacists are licensed.
Almost half of the states limit vaccines administered by pharmacists to those recommended by the CDC panel.
Access could also be complicated for healthy adults and children who are interested in vaccinating to obtain additional protection.
If the last vaccines are not covered by their insurance, these patients could have to pay 150 dollars or more of their pocket if they want to vaccinate. They could also have to find a doctor or other health professional willing to administer the “out of the indication” vaccine, that is, outside the use that appears on the FDA label. Pharmacists can be reluctant to administer vaccines out of what is indicated on the label.
Updated Pfizer, Modern and Novavax vaccines are directed to a coronavirus subtype called LP. 8.1, a recently dominant version of the virus that is closely related to some emerging variants.
The three vaccines were initially marketed under the authorization of emergency use of the FDA, an accelerated process to quickly review vaccines and other measures during the pandemic.
Modern received the total approval of the FDA in July for children up to 6 months and states that it should have enough supply to meet the demand of the United States.
In addition to revoking the emergency use of the Pfizer vaccine, the FDA also withdrew the authorization of several other therapies of the pandemic years, including the plasma of convalescent, which was used to treat hospitalized patients with COVID-19 before the first antiviral medications were available.
COVID-19 vaccines are effective in preventing serious disease, hospitalization and death, which remain a great risk for older people and for people with underlying health factors, such as heart, pulmonary and cancer diseases.
The preliminary data of the CDC estimate that 47,500 Americans died due to causes related to COVID-19 last year. In at least two thirds of those cases, the Coronavirus appeared as a underlying cause of death. In the rest it was a contributing factor.
