Why Get a COVID Booster Vaccine Quickly and How to Know Its Safety

The Food and Drug Administration (FDA), the US drug regulator, Said last week COVID vaccines updated for variants do not need to pass a fully randomized controlled trial.

Booster shots only need to undergo an initial test to ensure they are safe and generate an immune response. There is no need to conduct a lengthy “Phase 3” efficacy study, which typically enrolls tens of thousands of participants.

The European Medicines Agency has not published formal guidelines, but it takes the same position. Marco Cavaleri, Chair of the Institution’s Vaccine Evaluation Team, Told Reuters: “Requires a much smaller trial with hundreds of participants instead of 30,000 to 40,000.” The focus is primarily on safety and immune response data.

This is encouraging news as it means that you can access booster shots much faster than if you had a full trial. Safety is also guaranteed because pharmaceutical companies need to prove that they use the same technology and manufacturing process as the original vaccine.

The Australian Therapeutic Goods Service (TGA) has not yet confirmed if it will do the same, but history tells us that it can probably be expected to follow.

Why do you need a booster?

Mutants of the virus have been detected worldwide. What happened in the UK, South Africa, Brazil. People infected with these variants have been found in Australian hotel quarantine, and the first B.1.1.7 strain found in the United Kingdom has escaped the quarantine system several times.

For those tested, the current crop of vaccine is still Works relatively well For B.1.1.7 shares.

And the data suggest that most COVID vaccines are still Somewhat convenient For prevention of hospitalization and death due to these variants.

However, its effectiveness against mild to moderate illness and viral infections may decline sharply for some of these variants.

For example Preliminary data suggests Vaccine efficacy against AstraZeneca vaccine Dropped to only 10% For mild to moderate illness from the B.1.351 variant that occurred in South Africa. Novavax shot effectiveness slides from 89% Up to 60% for this variant.. These data are from small trials and require more research, but are still of great concern.

There are no solid real-world data on the performance of Pfizer vaccines against the B.1.351 variant.

Why don’t you need a full trial again?

Pharmaceutical companies Develop updated booster shots To cover these new variants, we need to tweak their sequence.

Some scientists say this does not mean that pharmaceutical companies will have to go through a fully randomized controlled trial, including a large phase 3 efficacy trial, to bring these booster shots to market. I was worried about it. These Phase 3 clinical trials involve thousands of volunteers and the main purpose is to determine if the vaccine helps prevent people’s illness.

By the time these trials are completed, it may be too late to control the outbreaks caused by the variants, and new variants that require coverage may emerge. In a pandemic, you can’t afford the time.

But the FDA has dispelled this fear.Drug regulator Seems to be the most interested To ensure that the booster shot is safe and the manufacturing process has not changed from the original approved vaccine.

Boosters will require smaller trials to show that they are safe and generate an immune response. Hundreds of people typically participate in this study to determine the proportion of volunteers vaccinated to make antibodies against the mutant and the strength of the immune response.

This is similar to what is done with an annual flu shot, but not exactly the same. Very different influenza strains are prevalent every few years, but the current COVID-19 vaccine and mutant “booster” may be sufficient for years to use-not yet known.

The FDA has also shown that boosters do not necessarily have to undergo animal testing before proceeding to human testing. This also saves time.But this may be encouraged When the results of human clinical trials are ambiguous..

How can I find out that they are safe and effective?

The potential side effects of the vaccine are: Mainly base About vaccine manufacturing method, technology, and vaccine delivery method.

If pharmaceutical companies keep all these factors the same and make only minor sequence changes to cover the mutants, boosters can still be expected to be a very safe vaccine.

US and EU drug regulators have given data that boosters will be given to those who have already been vaccinated with the original COVID vaccine, given that this is a likely scenario for most people who receive booster shots by the time they are approved. I want to see it.

Boosters will probably be tested even for people with COVID illness or no vaccine. This is to allow the booster to elicit a strong immune response like the original vaccine.

If necessary, TGA will review all this data individually. You may also be asked for advice from internal and external experts.

It’s also unclear when booster shots will be available or when they will be needed in the short term. Melbourne-based biotechnology company CSL, which manufactures AstraZeneca vaccine on land Said this week Booster shots covering coronavirus variants will probably not be available until the end of the year.

U.S. pharmaceutical company Moderna has already sent a new COVID vaccine booster shot for Phase 1 testing, B.1.351 Target the variant.Pfizer too Plan to develop boosters To cover this variant as either a third inoculation or a represcription vaccine.

New variants will continue to emerge, but the most likely to stop or delay this process is to continue public health measures to minimize the number of infected people.

This includes vaccination of as many people as possible with currently approved vaccines. This underscores Australia’s responsibility to support vaccination of countries in the region.

Jamie Triccas is funded by the National Health and Medical Research Council.

Anthony (Tony) Cunningham is funded by NHMRC, NSW Health, Australia’s Center for HIV and Hepatitis Virology, The Snow Foundation, and GSK. His institution receives rewards for consultations from GSK, Seqirus and Merck.