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Strong points
- The Centers for Disease Control and Prevention (CDC) reports that as of January 8, 2021, an estimated 6.7 million people had received at least one dose of a COVID-19 vaccine, well below the prediction of 20 million ending December 2020.
- It is likely that the new Biden administration’s new COVID-19 response staff will recommend new policies based on their assessment of distribution plans and the balance between federal and state response to maximize the distribution of vaccines nationwide, particularly to underserved populations most affected by the virus. Congress will likely legislate additional funding and policies as well.
- This Holland & Knight alert takes a closer look at the challenges of vaccine distribution both nationally and at state and local levels, as well as questions about dose flexibility and a small number of allergic reactions associated with the vaccine.
The Centers for Disease Control and Prevention (CDC) reports that as of January 8, 2021, about 6.7 million people had received at least one dose of a COVID-19 vaccine, well below the prediction of 20 million ending December 2020.
Updates and background to vaccine administration
On January 8, President-elect Joe Biden’s transition team announced that instead of keeping half the doses in reserve to ensure that people who received their first dose can receive their second dose, they would release the vast majority of available doses of authorized doses. vaccines at the same time. This is a reversal of the current Trump administration plan.
Biden is expected to announce more details of his administration’s plans for vaccine distribution this week. They should include the creation of federally managed vaccination sites, as well as mobile units that can reach rural and underserved areas, as well as the launch of a national public awareness campaign focused on vaccine safety. and guidelines.
On December 11, 2020, the United States Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the use of the Pfizer-BioNTech COVID-19 vaccine in people aged 16 and over. more, followed a week later by the FDA. issuing an EUA for the use of the Moderna COVID-19 vaccine for use in persons 18 years of age and older.Other vaccines are expected to be reviewed by the FDA in the coming weeks and months. (See Holland & Knight’s previous alert, “Operation Warp Speed and Vaccine Distribution Policies,” November 23, 2020.)
In addition to the age of the recipient, the two currently available vaccines have slightly different strengths. For Pfizer-BioNTech COVID-19 vaccine, the second dose is given 21 days after the first dose. For the Moderna COVID-19 vaccine, the interval is 28 days between the first and second dose.
Recent reports have called for reduced doses, to change the dose (provide only one vaccine) or to mix and match vaccines in order to vaccinate more people against COVID-19. The FDA has explicitly rejected all of these approaches, saying:
“At this time, suggesting changes to the dosage or FDA-approved schedules of these vaccines is premature and not firmly grounded in the available evidence … we run a significant risk of endangering public health,” undermining historic vaccination efforts to protect the population from COVID-19. “
Other countries, including the UK, the Netherlands, Belgium and Germany, are also looking for ways to make vaccine dosing more flexible. However, at this time no change in dosage is planned unless new clinical data are presented. Prompted by a proposal from the management of Operation Warp Speed (OWS), the government program overseeing the COVID-19 Accelerated Vaccine Development Program, the National Institutes of Health (NIH) is currently studying the effects of using ‘half a dose in the second dose. administration of Moderna vaccine. The results of these studies are pending.
Regulators have also called for more data in pregnant women and for certain risk factors such as heart disease, diabetes and other illnesses that could affect the immune system.
Recent reports also indicate that a small number of vaccinees have had allergic reactions, including anaphylaxis. According to the CDC, the rate of anaphylaxis is approximately 5.5 per 1 million doses of vaccine administered. Anaphylaxis is a known but rare side effect of vaccination, although the frequency with which it occurs after vaccination against COVID-19 appears to be higher than for some vaccines, such as influenza vaccines. Most of the people who developed the reaction have been treated with epinephrine. There was no geographic clustering of cases and not all people who developed anaphylaxis were vaccinated from the same batch of vaccine, suggesting that what is causing the reaction is not limited to one. single batch of product.
The CDC has explicitly said that the small number of allergic reactions does not change its recommendations on who should be vaccinated, the agency said, stressing that the positive effects of vaccination always outweigh the negative risks.
The CDC is urging all sites where COVID-19 vaccines are administered to be prepared to treat cases of anaphylaxis, including having epinephrine available.
State, local vaccine deployment still problematic
As mentioned earlier, the vaccine rollout has been considerably moderate compared to the initial targets and projections set by the Trump administration. The Coronavirus Response and Relief Supplementary Appropriation Act, 2021 (HR 133) included much needed funding to tackle the COVID-19 pandemic. However, only $ 3 billion of the $ 22 billion allocated for such efforts went specifically to state and local efforts on the distribution of the COVID-19 vaccine. States and localities have commented at length on the lack of resources, both financial and otherwise, to administer the vaccine at the rate the Trump administration and public health officials have urged. The Biden administration said the funding included in the bill for these efforts should be considered a “down payment.” Expect Congress to provide additional funding for these legislative efforts early this year.
Problems remain with cold chain storage and transport, which are necessary for the Pfizer vaccine, which must be stored at -70 ° C, and the Moderna vaccine, which must be stored at -20 ° C. Operation Warp Speed have estimated that 3,000 to 6,000 pharmacies could begin administering COVID-19 vaccines within the next two weeks. However, this figure is low compared to the roughly 40,000 pharmacies, including pharmacies within national pharmacy chains, which have been part of the OWS plans. This situation is exacerbated not only by a lack of capacity and medical personnel capable of administering the vaccine, but also by the presence of “pharmacy deserts”, a lack of access to pharmacies generally affecting underserved populations, due to closing less profitable pharmacies.
While the CDC has developed general recommendations on how to prioritize vaccine distribution based on the perceived risk of COVID-19 adverse events for certain populations, the level of increased exposure to potential COVID-19 patients and Other similar considerations, states remain the primary entities administering the vaccine and designing distribution protocols. This has resulted in very different distribution plans between states, prioritizing different populations at different times. Additionally, many states and localities are experiencing IT challenges with vaccine planning and are turning to using online platforms typically used to book entertainment and other events. Hospitals and other facilities receive unequal amounts of vaccine and in some cases are unable to dispense enough doses of vaccine after thawing and must dispose of extra unused vaccine.
These challenges further complicated distribution efforts. It is likely that Biden’s recently appointed COVID-19 response team will continue to assess distribution plans and the balance between federal and state response to maximize vaccine distribution nationwide. , in particular to underserved populations most affected by the virus.
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