There is good news about possible coronavirus vaccines and when they might be available.

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So, in an effort to balance that, I think it’s time to focus on some good news happening in the coronavirus field, which we’ll explore in a series of articles over the next few weeks. The truth is that we are making undeniable progress in our understanding of the disease, and although that progress is gradual, it is still worth noting.

To be clear, I am not going to choose only the good news: this will not be obvious, I will also include the bad news. And I think it’s important to note that the fact that we are understanding the virus more and more is not inconsistent with the increasing number of cases and deaths. That we are making progress in understanding the virus is, in any case, a reason to continue taking precautions. It is much easier to commit to wearing a mask when you can see the end.

At the start of the pandemic, Pfizer’s vaccine candidates, the “P” is silent, ruining my attempt at alliteration in the title of this section, they were not necessarily at the forefront of the race. But developments in recent weeks have made it clear that those scientists have been working hard and that their vaccine candidates have real potential.

They started by teaming up with Germany-based BioNTech, a smaller company with experience working with RNA vaccines. It was an extension of a flu-focused partnership they started in 2018, but when it became clear in mid-March that a global coronavirus vaccine would be needed, the companies agreed to work on that as well. They started with four candidate vaccines.

This month, they published data from a combined Phase I / II study on the safety and efficacy of one of their vaccines. Remember, these are small trials designed primarily to see if the vaccine is safe and to indicate its effectiveness. Large trials are still needed.

In total, 12 patients received 10 microgram doses on the first and day 21 of the study, 12 patients received 30 microgram doses at those same intervals, and 12 received a single 100 microgram dose at baseline. Nine people received a placebo.

After injecting this vaccine, there were some side effects. Reports of mild to moderate fatigue and headaches occurred in all groups (including placebo), but more frequently at larger doses. After the second injection, one person in the small dose group had a fever, while seven people in the medium group had a fever, and almost all resolved within one day. They decided not to give the large dose group a second injection due to these reactions.

These types of side effects are not uncommon in flu shots, although you obviously want to minimize them. One study found that one day, flu-like symptoms occurred in about 1 in 7 people who received the flu shot.

But the Pfizer vaccine clearly worked.

They compared how many antibodies each dosing group had against a group of people who had recovered from the coronavirus. After the first injection, those in the small dose group had almost twice as many antibodies as those who had recovered from the disease. The medium dose group was almost triple. And after that second dose, the small dose group had eight times the antibodies, while the medium dose group had 50 times the antibodies. There are many antibodies!

However, it is extremely promising that the vaccine worked even in the smallest dose group and even after a single injection. They are going to go ahead with the Phase III trial involving tens of thousands of people with the smallest doses, and think that by September they will have enough data to submit to the FDA, which could give “potential approval in October if we have luck, “according to the CEO of Pfizer at Time. On Monday, Pfizer announced that it had received an accelerated status from the FDA on this vaccine candidate, plus one closely related.

That progress brings Pfizer closer to Oxford, the leader in the vaccine career. Oxford is undergoing phase III trials in Brazil, South Africa and the United Kingdom. The United States is expected to add in August with patients at 33 sites across the country.

While Pfizer says it could receive FDA approval in October, the Oxford effort, fueled by support from AstraZeneca, believes it could have trial results in late August and be ready to administer part of the vaccine in September. , perhaps with the start of widespread distribution in October.

AstraZeneca is already starting to produce the vaccine, even before the Phase III trials are completed. The company recently committed to creating 2 billion doses, including 400 million by the end of 2020.

You may recall the Oxford vaccine from my last summary – it had promising results in humans, but when monkeys were given large doses of the virus, it prevented the severity of the disease but did not completely stop infections. Phase III is the stage designed to evaluate the effectiveness to the highest degree, so we will know soon if this vaccine works well or not.

Tuesday afternoon, Modern Finally He published the results of the first Phase I trial that excited us all in May about his RNA vaccine. Back then, they only had a press release, but now we have the results published in the New England Journal of Medicine. The study supports the hype, though we should note that, unlike the Pfizer vaccine, the levels of antibodies generated were only higher than the patients recovered after people received a second booster injection.

“The hallmark of a vaccine is one that can really mimic a natural infection and induce the kind of response you would get with a natural infection. And it seems that, at least in this limited and small number of people, that is exactly what is happening, “Dr. Anthony Fauci told STAT News about the trial. “The data really looks pretty good, and there were no serious adverse events.”

The downside is that the vaccine has had some daunting setbacks over time. The biggest is the delay in its Phase III test, which was supposed to start on July 9, but on Tuesday, the company announced that it will start on July 27. I don’t need to tell you that every week matters here, so a delay is not great.

The delay is due to changes in the test plan, the details of which were partially explained in an article by the University of Colorado, where 1,000 of the 30,000 patients nationwide will come from. They will be recruited from a variety of patients and hospital staff, and high-risk individuals will be among the analyzed population.

Trial participants will be followed for two years after receiving the injection, but that does not mean we have to wait two years for results: if the preliminary data is good enough, Moderna will request and will probably receive an emergency authorization from the FDA to give out before.

The Colorado physician cited in the article says that would mean widespread vaccination in the American public “by next spring.” Essentially, Moderna’s production and distribution capabilities may not be as good as that of the large pharmaceutical companies, although Moderna has closed deals to make 100 million vials, starting production in the third quarter.

Overall, Moderna still represents a promising candidate, and is still ahead of Pfizer’s RNA vaccine in terms of starting the Phase III trial.

China’s news about the progress of its vaccine makes fewer waves in the western world, but it still represents progress in our battle to understand what’s happening. I understand why people hesitate to accept the Chinese results, but the truth is that their research on the virus has been one of the best in the world since the end of January.

First, Sinovac reported positive results from its inactivated vaccine in Phase I / II trials in mid-June. Inactivated vaccines are some of the simplest forms of the vaccine: only part of the virus is taken, killed with heat and / or chemicals, and then injected. Then the body recognizes the infection and, hopefully, creates antibodies. Because the virus is dead, the body tends to create a weaker immune response than for other types of vaccines, making it something to watch out for. Still, having multiple ways to attack this problem is potentially really valuable.

Chinese government leaders did something nice with another vaccine candidate. Cansino’s Ad5-nCoV, which is a DNA vaccine quite similar to the Oxford effort, worked well in phase I / II trials. Then they approved its use in the Chinese army. That country is essentially using the military as the arm of the Phase III investigation. It is a defensible but questionable decision, and something that would not fly in the United States.

I don’t think the United States helps to produce and distribute a Chinese vaccine, but other nations plan to do so. Brazil, for example, signed an agreement with Sinovac to distribute millions of doses.

Some other positive aspects of the world of vaccines:

• One thing that doctors were somewhat concerned about is something called antibody dependent improvement (ADE) from these vaccines. You see, in some disease / vaccine combinations, antibodies can be created that bind to the virus that actually help The virus multiplies, it does not stop it. It’s something we’ve seen in dengue fever research, as well as in a small percentage of humans with RSV. Therefore, scientists have been on high alert for any improvement that occurs in any of these vaccine trials.

The good news: we have not seen ADE. We haven’t seen it in any of the human trials so far, in thousands of participants combined. And when we gave a promising vaccine to mice, we also didn’t see any ADE. Of course, it’s something to keep in mind when we start giving vaccines to tens of thousands of people in Phase III trials, but so far so good.

• Another concern was whether the vaccines would work only against certain strains of the virus. Remember, one strain was found in Asia and most of the early spread in the western United States, and another in Europe and the rest of the United States.

But a recent study found that antibodies created by disease in one variant are so effective in preventing infection in the other variant. That’s what most scientists expected, but still, it’s good to confirm. Our developing vaccines that pass the trials are likely to work against all that is currently spreading.

• Some of the first talks about vaccine trials focused on challenge tests: giving people a vaccine candidate, and then literally exposing them to the virus to see if the vaccine works. This is generally unethical, but in a global pandemic, it was something we were considering. More than 30,000 people signed up to be tested on a single website.

But with outbreaks reaching large numbers of people in various places, such as Brazil, India, Arizona, and Florida, there is simply no real need to break that ethical line. Instead, we can give the vaccine to people in those places and see if they get it in their daily lives. Obviously, it is terrible that we are in that position, but we do not need proof of challenge is the positive side.