Breaking News – The FDA has expanded the EUA for the Pfizer COVID-19 vaccine to included teens who are 12-15 years of age.
How’s that COVID-19 vaccine coming along?
Are we getting close to making a vaccine to protect us against SARS-CoV-2 infections?
Or will a coronavirus vaccine be impossible to make???
Like many things, it depends on who you ask…
COVID-19 Vaccine Update
While that probably doesn’t surprise anyone, let’s take a look at what we really do know.
321 236 COVID-19 vaccines are in development, and at least 44 63 have entered clinical trials, including many that have entered Phase III, the last steps in vaccine development:
- mRNA-1273 (Moderna) – has reported that their COVID-19 vaccine is 94% effective and has an EUA from the FDA and an ACIP recommendation for use in persons aged ≥18 years for the prevention of COVID-19
- Ad5-nCoV (CanSino Biologicals)
- INO-4800 (Inovio)
- LV-SMENP-DC and pathogen-specific aAPC (Shenzhen Geno-Immune Medical Institute)
ChAdOx1nCoV-19 (University of Oxford/AstraZeneca) – when given as a half-dose, followed by a full dose, their vaccine showed vaccine efficacy of 90%
- CoronaVac (Sinovac Biotech)
- 4 different SARS-CoV-2 RNA vaccine candidates (BioNTech SE / Pfizer) – has been given emergency use authorization (EUA) for their BNT162b2 vaccine by the FDA and has been approved in the UK, Canada, and has an ACIP recommendation for use in persons aged ≥16 years for the prevention of COVID-19
- Tableted inactivated vaccine from heat inactivated from COVID-19 patients (Immunitor) – Recruiting
- SARS-CoV-2 inactivated vaccine (Wuhan Institute of Biological Products co., LTD.)
- SARS-CoV-2 inactivated vaccine (Sinopharm)
- NVX-CoV2373 (Novavax)
- Ad26.COV2.S or JNJ-78436735 (Johnson and Johnson) – has received EUA in the US
- CureVac AG
Unfortunately, that means there is still a long way to go for some of these vaccines!
Well, at least it means the majority of people won’t be seeing a COVID-19 vaccine in the next few months.
We are getting much closer to the time whenStill, more and more high risk people front line workers start to get are finally getting vaccinated though.
Even with Operation Warp Speed, the collaboration between the US Dept of Health and Human Services and a number of private firms to accelerate development of 14 vaccine candidates, making a new vaccine takes time.
And right now, we have no idea how well any of these vaccines will work and what side effects they might cause.
None of that is unexpected at this stage. Remember, even though it is likely hard for most folks to believe, the COVID-19 pandemic is still relatively new.
“We have good candidates now. The top ones are around seven, eight. But we have more than a hundred candidates.”WHO Director-General Tedros Adhanom Ghebreyesus
The other thing that is discouraging is that we are still seeing misinformation about COVID-19…
And misinformation about the COVID-19 vaccines that didn’t even exist a few weeks ago!
“The MenACWY vaccine is being used as an ‘active control’ vaccine in this study, to help us understand participants’ response to ChAdOx1 nCoV-19. The reason for using this vaccine, rather than a saline control, is because we expect to see some minor side effects from the ChAdOx1 nCOV-19 vaccine such as a sore arm, headache and fever. Saline does not cause any of these side effects. If participants were to receive only this vaccine or a saline control, and went on to develop side effects, they would be aware that they had received the new vaccine. It is critical for this study that participants remain blinded to whether or not they have received the vaccine, as, if they knew, this could affect their health behaviour in the community following vaccination, and may lead to a bias in the results of the study.”The Oxford Vaccine Centre COVID-19 Phase I Clinical Trial Explained
On the bright side, we know that once these vaccines are developed, manufacturers will be ready to make and distribute them.
Or at least some of them will…
“To bring the disease to an end, we’ll need a safe and effective vaccine. If we do everything right, we could have one in less than 18 months — about the fastest a vaccine has ever been developed. But creating a vaccine is only half the battle. To protect Americans and people around the world, we’ll need to manufacture billions of doses. (Without a vaccine, developing countries are at even greater risk than wealthy ones, because it’s even harder for them to do physical distancing and shutdowns.)
We can start now by building the facilities where these vaccines will be made. Because many of the top candidates are made using unique equipment, we’ll have to build facilities for each of them, knowing that some won’t get used. Private companies can’t take that kind of risk, but the federal government can. It’s a great sign that the administration made deals this week with at least two companies to prepare for vaccine manufacturing. I hope more deals will follow.”Bill Gates: Here’s how to make up for lost time on covid-19
Let’s hope they do, as we will surely need a vaccine if the predictions of future waves of SARS-CoV-2 are true.
Other COVID-19 Vaccine Updates
What else is going on in terms of the COVID-19 vaccine?
- the National Vaccine Advisory Committee (NVAC) will meet on June 16 and 17 (scheduled meeting)
- the Advisory Committee on Immunization Practices (ACIP) at the CDC will meet on May 12 (emergency meeting) to discuss the Pfizer COVID-19 vaccine for 12-15 year olds
- the Advisory Committee on Immunization Practices (ACIP) at the CDC met on May 5 (scheduled meeting) to discuss rabies and dengue vaccines
- the Advisory Committee on Immunization Practices (ACIP) at the CDC met on Apr 23 (emergency meeting) to review the safety with Janssen’s COVID-19 vaccine (Ad26.COV2.S), get an update on thromboembolic events and vote on updated recommendations for further use
- the Advisory Committee on Immunization Practices (ACIP) at the CDC met on Apr 14 (emergency meeting) to review the safety with Janssen’s COVID-19 vaccine (Ad26.COV2.S), get an update on thromboembolic events and vote on updated recommendations for further use
- the Advisory Committee on Immunization Practices (ACIP) at the CDC met on Feb 28 and Mar 1 (emergency meeting) to vote on the Janssen COVID-19 vaccine, provide a COVID-19 vaccine safety update, and discuss emerging SARS-CoV-2 variants
- the Center for Biologics Evaluation and Research’s (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on Feb 26 to voted to grant emergency use authorization (EUA) for a COVID-19 vaccine from Janssen Biotech Inc.
- the Advisory Committee on Immunization Practices (ACIP) at the CDC met on Feb 24 and 25 (scheduled meeting)
- the National Vaccine Advisory Committee (NVAC) met on Feb 4 and 5
- the Advisory Committee on Immunization Practices (ACIP) at the CDC met on Jan 27 (emergency meeting) for an Update on COVID-19 Vaccine Administration COVID-19 Vaccine Effectiveness Studies Work Group Interpretation and Next Steps
- the Advisory Committee on Immunization Practices (ACIP) at the CDC met on Dec 19 and 20 (emergency meeting) to vote on the Moderna COVID-19 Vaccine and Allocation of initial supplies of COVID-19 vaccine: Phase 1b and 1c
- the Center for Biologics Evaluation and Research’s (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on Dec 17 “to discuss Emergency Use Authorization (EUA) of the Moderna, Inc., COVID-19 Vaccine for the prevention of COVID-19 in individuals 18 years and older” and voted to recommend that the FDA grant the vaccine EUA.
- the Advisory Committee on Immunization Practices (ACIP) at the CDC met on Dec 11 and 12 (emergency meeting) to talk about the Pfizer-BioNTech COVID-19 vaccine and vote on an Amendment to the 2021 Child and Adolescent and Adult Immunization Schedules (it was approved)
- the Center for Biologics Evaluation and Research’s (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on Dec 10 “to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH” and voted to recommend that the FDA grant the vaccine EUA.
- The National Vaccine Advisory Committee (NVAC) will met on Dec 4 to discuss Approaches to include pregnant women in covid-19 clinical trials and vaccine safety systems and covid-19.
- the Advisory Committee on Immunization Practices (ACIP) at the CDC met on Dec 1 (emergency meeting) to talk about COVID-19 vaccines, including Allocation of initial supplies of COVID-19 vaccine
- the Advisory Committee on Immunization Practices (ACIP) at the CDC met on Nov 23 to talk about COVID-19 vaccines, including the Phased Allocation of COVID-19 Vaccines
- the Advisory Committee on Immunization Practices (ACIP) at the CDC met on Oct 28-30 and the final day of the meeting was about COVID-19 vaccines
- the Center for Biologics Evaluation and Research’s (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on Oct 22 to discuss “the development, authorization and/or licensure of vaccines to prevent COVID-19”
- the FDA Issued updated Guidance on Emergency Use Authorization for COVID-19 Vaccines
- COVAX is working to have 2 billion doses of COVID-19 vaccines available to protect high risk and vulnerable people around the world by the end of 2021
- the Access to COVID-19 Tools Accelerator is working toward the accelerated development, equitable allocation, and scaled-up delivery of vaccines, therapeutics and diagnostics for COVID-19
And the biggest news?
We finally have COVID-19 vaccines! And are getting closer to getting more and more folks vaccinated and protected.
As Pfizer has asked the FDA to expand the ages for its COVID-19 vaccine to 12 to 15 year olds, we can likely also look for announcements of new meetings from the FDA and ACIP as they make a decision on this new age indication.
More on COVID-19 Vaccines
- COVID Vaccines for Children Should Get Emergency Use Authorization
- Where Are the COVID-19 Package Inserts?
- Will New COVID-19 Vaccines Be Approved for Kids?
- Reasons to Be Confident in a COVID-19 Vaccine
- COVID-19 Vaccine Challenges
- Would Most People Say No to a COVID-19 Vaccine?
- Where Are the Pediatric COVID-19 Vaccine Trials?
- Will COVID-19 Vaccines Be Mandatory?
- About That Russian COVID-19 Vaccine…
- Where Are the Pediatric COVID-19 Vaccine Trials?
- Beware of Folks Pushing the Idea That COVID-19 Vaccine Trials Will Fail from the Start
- QAnon Vaccine Conspiracy Theories
- Can Vaccines Alter Your DNA?
- About That Mass COVID-19 Vaccination Campaign in Senegal…
- What Has Dr. Fauci Said About a COVID-19 Vaccine?
- What You Need to Know About a COVID-19 Vaccine
- Are They Putting the COVID Vaccine in Flu Shots?
- Get All of Your COVID-19 Questions Answered
- The Second COVID-19 Wave Might Not Be COVID-19
- AstraZeneca resumes U.S. COVID-19 vaccine trial and next week J&J prepares to do same
- University of Oxford resumes vaccine trial
- Statement on AstraZeneca Oxford SARS-CoV-2 vaccine, AZD1222, COVID-19 vaccine trials temporary pause
- Pressing the pause button after an adverse event happens to a vaccine trial participant
- Fauci will oppose any rush to announce COVID-19 vaccine before ‘scientifically sound’
- Scientists were close to a coronavirus vaccine years ago. Then the money dried up.
- WHO – Draft landscape of COVID-19 candidate vaccines
- CEPI – 321 vaccine candidates against COVID-19 now in development
- The latest in the COVID-19 vaccine race
- COVID-19 vaccine tracker
- COVID-19 Vaccine Frontrunners
- BARDA’s Rapidly-Expanding COVID-19 Medical Countermeasure Portfolio
- Coronavirus: what have scientists learned about Covid-19 so far?
- The Oxford Vaccine Centre COVID-19 Phase I Clinical Trial Explained
- IVI, INOVIO, and KNIH to partner with CEPI in a Phase I/II clinical trial of INOVIO’s COVID-19 DNA vaccine in South Korea
- WHO – Commitment and call to action: Global collaboration to accelerate new COVID-19 health technologies
- Landmark global collaboration launched to defeat COVID-19 pandemic
- Coronavirus vaccine: when will we have one?
- The Race To Develop A Coronavirus Vaccine
- Bill Gates: Here’s how to make up for lost time on covid-19
- Vaccines are the long-term solution to the pandemic – BBC World News
- Announcing the COVID-19 Therapeutics Accelerator
- CEPI establishes global network of laboratories to centralise assessment of COVID-19 vaccine candidates
- WHO – “Immunity passports” in the context of COVID-19
- How will we know whether the coronavirus will come back stronger in the winter?
- When Will Our Coronavirus Vaccine Arrive?
- NWV Fights COVID-19 Misinformation
- Vaccine challenge studies – can it speed up coronavirus vaccine licensing?