FDA Opposes COVID-19 Vaccination Dose and Schedule Changes to Vaccinate More People

FDA Opposes COVID-19 Vaccination Dose and Schedule Changes to Vaccinate More People

Only two weeks after the first experimental biologic for SARS-CoV-2 became available, the U.S. was more than 16 millions doses behind Operation Warp Speed’s goal of giving COVID-19 vaccines to 20 million people by the end of 2020.1 Responding to the slow rollout, Operation Warp Speed chief adviser Moncef Slaoui, MD proposed giving half-doses to speed up vaccination efforts.2 “We know [a 50-microgram dose] induces identical immune response to the 100-microgram dose, and therefore we are in discussion with Moderna and with the FDA,” Dr. Slaoui said.3 The call to cut vaccine doses in half in order to give more people a first dose of COVID-19 vaccine is opposed by the U.S. Food and Drug Administration (FDA), which cited lack of scientific evidence to support the change.4

As an alternative to cutting COVID-19 vaccine doses in half, there have been other proposals for giving more people a first dose. An op-ed in the The Washington Post on Jan. 3, 20215 called for delaying the administration of second doses of the vaccine in order to vaccinate more people with a first dose more quickly.

On Dec. 30, 2020, officials in the United Kingdom decided to delay the second dose to “within 12 weeks” of the first one as the best way to apportion a limited number of doses, despite “scant clinical evidence” that a 12-week gap will be as effective as a 21-day one.6 Other European countries are in the process of deciding whether to follow their lead,7 8 although the European Medicines Agency (EMA) has argued against the move, saying it departs from proven clinical trials.

Another idea for accelerating the rollout of different types of COVID-19 vaccines in the U.K. was made by the Joint Committee on Vaccination and Immunization. The committee suggested that in emergencies, a second dose of a different manufacturer’s vaccine might be used if the same manufacturer’s vaccine given as the first dose wasn’t available, or if it was unknown which type of vaccine was first administered.9

Two Experimental mRNA Vaccines Being Distributed in U.S. Under Emergency Use Authorization

In December 2020, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to two experimental COVID-19 vaccines: Moderna’s mRNA-1273 and BioNTech and Pfizer’s BNT162b2, both of which are messenger RNA vaccines that are intended to be administered in two-shot regimens delivered intramuscularly three or four weeks apart. A statement released by the FDA on Jan. 4, 2021 noted…

Those participants who did not receive two vaccine doses at either a three-or four-week interval were generally only followed for a short period of time, such that we cannot conclude anything definitive about the depth or duration of protection after a single dose of vaccine from the single dose percentages reported by the companies.10

The Pfizer and Moderna COVID-19 vaccines are the first using mRNA technology, and the companies did not study extended dosing schedules. Pfizer has objected to the proposal that the vaccine be used with a longer interval time between vaccinations.11

Second Doses of COVID-19 Vaccine Held in Reserve

Due to concerns about manufacturing and supply chain issues, the federal government and some hospitals have held back vaccine doses to ensure those who have received the first shot will have guaranteed access to the second. Currently, the government is holding back more than half of the vaccine inventory for second doses. However, both Pfizer and Moderna are ramping up their vaccine production.12 13

FDA Claims Dosing and Schedule Changes Not Anchored by Evidence

Nobody knows for sure how effective a single dose of COVID-19 vaccine will be in preventing moderate to severe COVID-19 disease or for how long, given that clinical trials were set up to test a two-dose schedule. Furthermore, health officials are concerned that giving people half doses or only one dose of the vaccine or delaying administration of the second dose could increase the chance of the virus evolving to resist any effect of the vaccines.14

FDA chief Stephen Hahn and agency vaccine center director Peter Marks rebuffed any changes to the current plan in a statement, saying, “at this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence… Making such changes that are not supported by adequate scientific evidence may ultimately be counterproductive to public health.”15

“A Risky Venture” To Change Dosing or Schedules for COVID-19 Vaccinations

“I understand some of the rationale to do this, but again, it’s not really data driven,” said Norman Baylor, PhD, former FDA director. “It’s a very risky venture because if it fails, you’re in worse shape.”

Dr. Baylor, who previously headed the FDA’s Center for Biologics Evaluation and Research, further elaborated that there isn’t enough data to fully whether administering just one dose or delaying administration of a prolonged second dose of COVID-19 vaccines will prevent moderate to severe COVID-19 disease. While more people would receive a vaccination by increasing the time between the administration of both doses, the outcome may be different from what the clinical trials suggested.16

STAT described the move in the U.K. to change dosing schedules as “effectively turning [the U.K.] into a living laboratory.” The U.S. news outlet accused the U.K. of basing its new vaccination schedule “on small slices of evidence mined from ‘subsets of subsets’ of participants in clinical trials… and on general principles of vaccinology rather than on actual research into the specific vaccines being used.” It added…

If the efforts succeed, the world will have learnt a great deal. If they fail, the world will also have gained important information, though some fear it could come at a high cost.17

Could a Gap Between Doses Lead to Vaccine Resistant Strains of SARS-CoV-2?

Paul Bieniasz, PhD, a retrovirologist from Rockefeller University, is watching the dosing debate with dread. Dr. Bieniasz, who is studying how the SARS-CoV-2 virus can acquire mutations, has warned that the U.K. was taking a gamble that risked fostering vaccine resistant forms of the virus.”18 He told STAT…

My concern, as a virologist, is that if you wanted to make a vaccine-resistant strain, what you would do is to build a cohort of partially immunized individuals in the teeth of a highly prevalent viral infection.19

Collecting Safety Data Difficult When Vaccines Interchanged

Several researchers have noted that it is far from certain that the vaccines are interchangeable “None of this is being data driven right now,” said Phyllis Tien, MD, an infectious disease physician at the University of California, San Francisco. “We’re kind of in this Wild West.”20

Swapping out one manufacturer’s vaccine for another by allowing different COVID-19 vaccines to be used interchangeably for the first and second doses may still help protect against COVID-19 disease, but it remains a scientific gamble. With different ingredients in each vaccine, there are many outstanding questions about the hybrid vaccination approach.21


Click here to view References:

1 LaVito A. Sluggish Vaccine Campaign Raises Specter of U.S. Dysfunction. Bloomberg Dec. 30, 2020.
2 Ehley B. Feds may cut Moderna vaccine doses in half so more people get shots, Warp Speed adviser says. Politico Jan. 3, 2021.
3 Lee J. Slaoui proposes half-doses of Modern’s COVID-19 vaccine to speed vaccinations. Market Watch Jan. 4, 2021.
4 Vergano D. A. Slow Start to COVID-19 Vaccines Has The FDA Facing Calls To Change Shot Schedules. Buzzfeed News Jan. 7, 2021.
5 Wachter R, Jha A. It’s time to consider delaying the second dose of coronavirus vaccine. The Washington Post Jan. 3, 2021.
6 Dunn K, Kahn J. The U.K. is delaying the second dose of COVID vaccines to 12 weeks. Is that even safe? Fortune Jan. 12, 2021.
7 McKie R. Why is Britain delaying second doses of Covid vaccines? The Guardian Jan. 3, 2021.
8 Hughes C. European countries delay giving second dose of COVID-19 vaccine. UPI Jan. 6, 2021.
9 Vergano D. A Slow Start to COVID-19 Vaccines Has The FDA Facing Calls To Change Shot Schedules. Buzzfeed News, Jan. 7, 2021.
10 Hahn S, Marks P. FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines. FDA Jan. 4, 2021.
11 Branswell H. Britain takes a gamble with Covid-19 vaccines, upping the stakes for the rest of us STAT News Jan. 4, 2021.
12 Dai T, Yadav P. Why holding second doses of COVID-19 vaccines in reserve is the wrong strategy. USA Today Jan. 12, 2021.
13 Ehley B. Feds may cut Moderna vaccine doses in half so more people get shots, Warp Speed adviser says. Politico Jan. 3, 2021.
14 Vergano D. A Slow Start to COVID-19 Vaccines Has The FDA Facing Calls To Change Shot Schedules. Buzzfeed News Jan. 7, 2021.
15 Ibid.
16 Kelley A. ‘Very risky’ to delay second dose of COVID-19 vaccine, says former FDA director. The Hill Jan. 7, 2021.
17 Branswell H. Britain takes a gamble with Covid-19 vaccines, upping the stakes for the rest of us. STAT News Jan. 4, 2021.
18 Iacobucci G, Mahase E. Covid-19 vaccination: What’s the evidence for extending the dosing interval? The British Medical Journal Jan. 6, 2021; 372: n18.
19 Branswell H. Britain takes a gamble with Covid-19 vaccines, upping the stakes for the rest of us. STAT News Jan. 4, 2021.
20 Wu K. Britain Opens Door to Mix-and-Match Vaccinations, Worrying Experts The New York Times Jan. 1, 2021.
21 Ibid.

10 Responses to "FDA Opposes COVID-19 Vaccination Dose and Schedule Changes to Vaccinate More People"

  1. Redpill   January 19, 2021 at 12:29 pm

    The manufacturers of these products, which by the way are not vaccines because they don’t immunize or stop transmission, made a point of designating a specific timeline for the vaccine to be given. Now, that their plans have gone haywire and more information is being made public in regards to adverse effects and deaths they want to move the goalpost. They just will not come out and admit that a fast tracked treatment resembling a vaccine that scientists have been trying to make since the late 1990’s but have given up on because they couldn’t make it safe for humans, is a bad idea. Interesting Dr. Peter Hotez stated in a congressional hearing last spring that this virus was not the one to make a vaccine for.

    Reply
    • Kimberly   January 19, 2021 at 6:02 pm

      They’ve been moving the goal posts consistently since March 2020…

      Reply
      • Dun Withfear   January 21, 2021 at 12:06 pm

        The UK would like to opt out of being made into “lab rats” in addition would request all money invested in both government and vaccines as both are not suitable for purpose. In fact both are hazardous to human life.

        Reply
    • Tom   January 19, 2021 at 8:20 pm

      Right on!

      Reply
  2. Mike   January 19, 2021 at 5:58 pm

    So true, vaccination does not equal immunization. The fact that schools ask for immunization papers is a joke. What they really want is proof of vaccination. They could give a damn about immunization.

    Reply
  3. Tom   January 19, 2021 at 8:19 pm

    This all nonsense. Neither of these gene therapy technologies, admitted as such by Moderna, which under no legal definitions can be termed vaccines, were not tested for anything but MILD cases. There were specifically not trialed for severe cases or to see if they might prevent death. In all logical, forthright sense, why would anyone need a gene altering therapy to protect against mild cases that for all intents and purposes has very, very little associated risk?

    The CDC is insane. All other previously approved vaccines had two specific markers in that they would prevent severe, life threatening cases and that they would slow or stop the spread of a disease. And even those claims has never been properly and completely substantiated or documented…EVER! These new concoctions do neither and have not been proven or shown to do either.

    In case you might be wondering, these fake vaccines are still undergoing trials through the next TWO years, at least. And guess what? Anyone taking these potions are the lab rats that Gates is using to perfect his population controlling poisons which will eventually use nano-particles injected into your body to be used as a controlling/thought altering device.

    Reply
  4. Lehcar   January 19, 2021 at 8:35 pm

    So many sheep following. Stay woke people. “Population control” is on! Ready, Set, Go

    Reply
  5. Colorado   January 19, 2021 at 9:44 pm

    Requesting a person or company, whom will provide vaccination records without actually forcing us to get vaccinated. Will pay any price.

    The government did successfully do one thing with these lockdowns and mass psychosis hypochondriac hysteria, they created a black market for fictitious vaccine compliance paperwork.

    People, if you have received the vaccine or someone in your family has, please post those documents online so we can scan them and forge them ourselves. When tyranny becomes law, resistance becomes duty.

    My health is my business. I chain smoke, power drink, eat greasy foods, stay up late, and watch intellectually deficient programming like mainstream news and squidbillies on a regular basis. I don’t give a crap about viruses in the wild. Don’t touch the trim.

    Reply
  6. JennyM   January 19, 2021 at 11:12 pm

    I wonder if they are trying to surreptitiously ‘water down’ the dose and are hoping it keeps people from having such severe reactions to it.

    Reply
  7. Dani   January 20, 2021 at 10:57 am

    I was thinking the same. There’s so much attention right now on the adverse reactions that they’re getting nervous about continued uptake. Clearly it’s a bad idea for actual adverse event tracking purposes, but it may also be a bad idea for their purported efficacy rate. They may be in a position to have to choose what’s worse for their products image. Either way they are going to catch flack for their failures. I’m more concerned about adverse events actually getting tracked…their fake efficacy rates mean nothing to me.

    Reply

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