COVID MODERNA VACCINE -17TH NOV 2020-UPDATE

[gmohan]

Covid-19: Moderna vaccine is nearly 95% effective, trial involving high risk and elderly people shows

BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4471 (Published 17 November 2020)
Cite this as: BMJ 2020;371:m4471

The UK government has secured five million doses of the covid-19 vaccine candidate mRNA-1273 from US biotech company Moderna after interim analysis of its phase III trial showed it was 94.5% effective.

If the vaccine meets standards of safety and effectiveness and is approved by the medicines regulator, the vaccine could be delivered to the UK and Europe as early as spring 2021 with the potential to procure more doses next year, a government statement said.

The trial’s Data Safety Monitoring Board—which was appointed by the US National Institute of Health—carried out the analysis based on 95 covid-19 cases, of which 90 were observed in the placebo group and five were reported in the vaccine group.

The trial enrolled more than 30 000 US participants, including 7000 aged over 65 and 5000 under 65 with high risk chronic diseases. More than one third (37%) of the trial participants are non-white, with 6000 participants identifying as Hispanic and more than 3000 identifying as black.

Of the 95 cases, 15 were in adults over 65, and 20 identified as being from diverse communities (12 Hispanic, four black, three Asian American, and one multiracial).

Moderna intends to submit the interim safety and efficacy data to the US Food and Drug Administration (FDA) for emergency use authorisation within the next few weeks, following a final analysis of 151 cases and a median follow-up of more than two months. The trial is being carried out in collaboration with the National Institute of Allergy and Infectious Diseases.

The news comes just over a week after pharmaceutical company Pfizer announced that its covid-19 vaccine candidate was more than 90% effective, following its interim analysis.1 Neither Pfizer nor Moderna have published their full results yet, only releasing information through press releases.

As well as meeting the primary endpoint of the trial (prevention of symptomatic covid-19 disease), the monitoring board looked at the secondary endpoint—prevention of severe disease. There were 11 severe cases of covid-19 reported, all of which occurred in the placebo group.

Professor of experimental medicine at Imperial College London Peter Openshaw, who sits on a Scientific Advisory Group for Emergencies subgroup, said, “This news from is exciting and boosts optimism that we will have a choice of vaccines in the next few months.

“Moderna has announced that the vaccine can be kept in a conventional freezer for up to six months and that once thawed can be kept for up to 30 days in a standard refrigerator. This makes the vaccine much easier to deliver.”

Openshaw added that while more details are needed, this announcement “adds to the general feeling of optimism about vaccines for covid-19. What we still don’t know is how long any protective immunity may last.”

The UK government has so far secured deals for seven vaccine candidates, including Moderna’s. A deal has been secured for the Pfizer vaccine, although concerns over logistics have been raised, as it has been reported that it needs to be stored at −70°C.

No significant safety concerns for the Moderna vaccine candidate have been reported and a review of solicited adverse events found that the vaccine was generally well tolerated.

Eleanor Riley, professor of immunology and infectious disease at the University of Edinburgh, said, “The safety data also look promising. The side effects of vaccination appear to be in line with those typically seen for other adult vaccinations, including the seasonal influenza vaccination which is administered in many millions of doses every year.

“One important unknown is whether this vaccine, or any of the vaccines currently in trials, prevents disease transmission. It is likely that vaccines that prevent symptomatic disease will reduce the duration and level of infectiousness, and thus reduce transmission, but we don’t yet know if this effect will be large enough to make any meaningful difference to the spread of the virus within communities.

“Overall, this is excellent news. Having more than one source of an effective vaccine will increase the global supply and, with luck, help us to get back to something like normal in 2021.

[uamohammed]

Hi Mohan
After a long time we meet in this forum.
you have come up with a topic which is very hot all over the world. That is Covid 19 vaccines.
First thing I want to know is regarding the claim that the potency of the vaccines is retained for six months if kept in a conventional freezer. The discovery of the vaccine is very recent only, not six months in any case. Then how can one vouch for its potency in advance if kept in a freezer for this long?
You have yourself stated they have not released full report. At least they should have apprised the medical profession. They have selected two groups one which was given the vaccine and the other a placebo. The results are impressive though the number is miniscule compared to the world population. What I want know is whether those vaccinated were allowed to mingle with general population without any Covid 19 protocols such as masks, sanitizer and social distancing. There is one school of scientists who say such vaccinated should be challenged with covid 19 viruses by freely mingling with known cases of positively tested symptomatic patients. The second point is the most important. How long one is to wait to know the side effects which may occur months after vaccination. Isn’t it too early to say anything about the distant effects?
Another fear expressed in some section is about the material administered for vaccination. As we all know that usually one gets immunity to particular illness is to suffer from the infection when our immune system comes to deal with the invader and produce antibodies which would stay in our system either permanently or for a specific period. Another way is to administer the specific bacterium or virus either killed or attenuated form to modulate our immune system to produce antibodies against a future challenge. But the present vaccines are believed to be genetically engineered ones. We have already become accustomed to genetically engineered foods for which all over the world there is vehement opposition. The environmentalists warn us that the genetically modified ones may alter our ecosystem and may be harmful to our body itself. If that were so, how can we be sure that the genetically modified vaccines are safe to human beings. Unless we wait for a sufficiently long time how can we be sure of the safety of these vaccines.
What is strikingly evident is that everyone is in a race to defeat the rest to bring the vaccine to the market. Apart from the financial interests of companies, the political clout all over the world is also in a hurry to bring the vaccine to their citizens. The most striking example is the hurry shown by President Trump in coaxing the companies to bring the vaccine out so that he could score in the election. It is said that he even was pressurising regulatory agencies to overlook on the details. The general public is also blindly welcoming the vaccines so that they can get away from the present precautions advised against the spread of this virus. What we see is that people are not ready to follow basics such as wearing masks and observing social distancing. What does it mean? Once the vaccines arrive, the public would become more complacent. Even if the vaccines are effective and safe it would take some time before our system would start producing the antibodies. The period between the vaccination and development of immunity is very danger one. The complacent general public by discarding all the protocols may help accelerate the spread of this dreaded menace during this latent period.

UA Mohammed

[gmohan]

Most relevant and practical questions dear Mohammed.

The BMJ article does not authenticate any other info , and we would need to wait for more published info from Moderna.

Best wishes.

[Badri]

There is a lot of talk about the different vaccines being used by different countries at the moment. With no long term results on the efficacy of any of them, you can never be sure which one is better. We will probably get an answer in only 3 to 5 years time. In the meantime we just have to get vaccinated by one of them and hope for the best. Only thing that we should make sure is that we get the same vaccine for the repeat injection 6 weeks later.

[uamohammed]

yes, that is a reasonable attitude. But we have to continue all the precautions such as mask, sanitizer and social distancing for a long time.

UA Mohammed